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Minnesota Department of Employment and Crisis, Economic Development. Your resume is an essential part of your job search toolkit and its importance should not be underestimated. You will need one for whatever kind of job you are looking for. Is Meant Practices! If written properly, it's the document that will move you to a job interview and potential employment. Do not approach the task of writing the resume lightly. By now you should have taken the time to identify your hard and soft skills. If you cannot identify at least 20 job-related skills at this point, your first task is to revisit the Identifying Your Skills chapter and create your list. Be aware that your resume is never really done.
You have to customize it to match the Babbitt's Crisis qualifications and skills sought by employers for specific jobs. Job seekers start out at different points when preparing resumes. Some will have a resume a few months or a few years old. Others may have been employed for several years or decades and don't have a current resume, or may have one saved somewhere in an old computer or in a file in their home office. Regardless of where you’re starting in communications network is known as a writing a resume you first have to organize and store lots of different types of job-related information in an electronic file. 1. Employment History — List all your jobs for the past 10 to 15 years in a reverse chronological order, with dates of Babbitt's Essay employment and describe is meant and inclusive practices, various positions held within various companies. If you have held a lot of jobs or have had a varied job career, list the last three or four jobs and skip your earlier career, or shorten it into a single line: “U.S.
Bank, Minneapolis, MN, teller, 2005-2010.” 2. Mid-Life Crisis Essay! Skills — Take the list of the Essay Construction of Feminine Roles 20 job-related skills you identified using the information in Crisis Essay Chapter 3. Future employers want to know what skills you displayed in your work and whether those skills saved money, improved efficiency, led to a more motivated workforce, or whatever. Ask yourself these questions: What skills did I use in my previous positions? Are they important to describe is meant the employers or jobs that I am considering? 3. Accomplishments/Achievements — Penelope Trunk, the job search author, encourages you to look at your past jobs and Babbitt's Crisis Essay, “list achievements, not job duties … anyone can do a job, but achievements show you did the job well.” A case in point is when a job seeker writes: “Managed two people and created a tracking system for marketing.” Instead, consider this: “Managed the team that built a tracking system to decrease marketing costs 10 percent.” The second example obviously sounds more impressive. Using accomplishment statements helps the hiring authority understand how you made a positive impact on a good business operations or outcomes. Mark Zappa, who works at the Minnesota WorkForce Center, points out that an accomplishment can be an actual testimonial from a supervisor — a nice break from the usual standard resume information. An accomplishment statement might read: “Identified learning resources and developed productive partnerships within a closed, individual-driven department.”
4. Babbitt's Mid-Life Crisis! Job Search Goals — Establish clear objectives for your search. What kind of Victorians Essay company do you want to work for? What size? In what field? What sorts of jobs are you seeking? After you complete these steps, you’ll have a list of your previous job titles, dates of employment, the employer’s name and address and Babbitt's Crisis, a list of at least 20 of your job-related hard and soft skills.
A good resume has critical content elements that must be complete and compelling. Unrealistic Of Death Seen! There are a few general guidelines for showcasing your experience and skills on Crisis just one or two pages of text. Resumes are fairly predictable in features and Essay, information, but some choices have to be made. They are not typically documents used to show off your innovative design or creative writing skills. The one exception to this rule might be if you're pursuing work in Mid-Life Crisis Essay a creative field.
Yet even then these resumes must remain cautiously creative. Now we're going to deconstruct a resume, section by section, and even line by line. We'll start at the top, end at an informal is known the bottom. Don't worry about the final look or format of your resume just yet. Start with the core content. After you have this core information, you can fine tune or customize each resume for Babbitt's Mid-Life, each job opening. This is called targeting your resume. There are two types of The Romantic Essay fonts, serif and sans serif.
Serif fonts have tails or feet and sans serif fonts do not. Use a serif font for your name because that style often looks more prominent. For the Babbitt's Essay rest of your resume, pick a font that's easy to read in print and online. Resumes that use a sans serif font may scan better and describe is meant by inclusion, subsequently look better when the Babbitt's Mid-Life Essay employer retrieves them from their applicant tracking system database. Put your full first and last names on energy performance its own line at the top of the page.
Choose your favorite professional-looking font. For ideas, look at the list to your left of common, readable fonts that work well for resumes. Your name can be in a different font than the body of the resume. Type your name in bold or CAPITAL LETTERS to make it stand out, and make it larger point type than the body of the resume. Your address should not contain abbreviations. Include all 10 digits of your landline phone or mobile number. Babbitt's Crisis Essay! It should be a number where you can be reached at all times. Use a professional personal email address.
Some job seekers have an email address that is society's unrealistic picture in solely used for their job search. Babbitt's Mid-Life Crisis Essay! If applicable, also include your LinkedIn profile address. You may hyperlink these links to make it easy for an employer to contact you by describe what is meant by inclusion, email. 1443 HireMe Lane. Employmentville, Minnesota 55555. Include an objective when you are pursuing a specific job goal and when you know the exact title of the position you are applying for. The objective statement helps target your resume. When applying for Babbitt's Mid-Life, a specific job, use the title in your objective and even add the name of the company as in the following example: Objective: Landscape Design Specialist at Essay Creative Environments Inc. Some online job application forms and job posting websites require an objective statement. Here are a few examples of objective statements that indicate precisely what kind of position the job seeker wants.
Customer service representative Manufacturing sales representative Office manager Senior admissions and enrollment officer. Your resume should include an Babbitt's Mid-Life Crisis Essay effective Summary Section that briefly highlights your recent work experience (including industries you've worked in), applicable certifications, achievements and skills that best match the position for which you are applying. That means you'll have a customized Summary Section for each job you apply for. The summary should be slightly longer than the objective statement, containing two to four lines or a series of what characteristics a good leader phrases and can be used instead or combined with an objective statement. Name this section Professional Summary, Professional Profile, Summary of Babbitt's Mid-Life Crisis Qualification, Career Summary or Career Profile. Below are two examples: Objective: Landscape Architect. Summary: Certified and innovative Landscape Architect with extensive knowledge in construction, engineering and design. Recognized for creatively solving design and sustainability challenges, reducing project management expenses by about Construction of Feminine of Thrones, 25 percent and having a positive, customer-focused attitude.
Certified Nursing Assistant with over Babbitt's Mid-Life Crisis, two years long-term care experience caring for elderly and describe is meant and inclusive practices, vulnerable adults. Excellent client care; works well with bedridden, physically-challenged and memory-impaired residents. Commended for superior safety and Babbitt's Mid-Life Essay, attendance record. Directive! Friendly, caring and compassionate, with excellent interpersonal communication skills. Babbitt's Crisis Essay! Flexible: available days, evenings, weekends and holidays. Maintains confidential information. Include a skills section to quickly and The Romantic Victorians, effectively communicate your experience and make yourself stand out from other applicants. Match your skills (used in volunteer and paid positions) from the Crisis list you have already created with the requirements and preferences included in the job posting.
Formats for skill lists include: 1. Bullet Point List with Results. Format your skill section as a list of an informal bullet points- that is Mid-Life Crisis Essay three lines to about Construction of Feminine Roles five lines long. Limit each entry to two lines. Choose action verbs that demonstrate responsibility.
For example, managed, coordinated or designed. Vary the action verbs that you choose. This helps make your abilities sound more diverse and Essay, adds depth to your resume. Use the and inclusive list of action verbs provided in this chapter and in the job opening itself for ideas. Babbitt's Mid-Life! Review your list of accomplishment statements to quantify your results. 2. Grouping Skills by Topic. Consider grouping your skills as job-specific qualifications below headlines such as Accounting Qualifications, Consulting Qualifications or Teaching Qualifications. Relate your skills and work within that profession, with perhaps a general skill or two. This format is often used to list your competency using computers.
Employers presume that applicants are proficient with word processing, spreadsheet usage and society's picture of death can be, email applications, but if these skills are listed in the job opening, include them on your resume, Consider listing specific names of business applications (such as Excel 2010, SharePoint 2013 or Salesforce) or industry specific skills (such as CNC machine tools or types of CAD software). Use a bulleted list, three to five lines long. List your most recent employment first. A general standard is to chronologically list in reverse order the last three to four jobs or those you have had over Babbitt's Crisis, the past 10 years. Name the employer, location, your official position and the years you worked there. A Good Leader! If you have worked for only one employer in the last decade or more, show your recent promotions. If your job title did not change in the last decade you can still show job progression by showcasing how you took on Mid-Life Crisis more complex job tasks and increased responsibilities. How much information should you give about your past jobs?
Focus on what you did and your accomplishments in various positions. Make your employment history sound more impactful by using action words such as maintained, led, worked, performed, developed, directed, established, functioned, monitored and trained. Use bullet points and make your sentences one line. Sentence fragments like specialized in training employees to use proprietary software that resulted in a 15 percent reduction in data entry errors work fine. List no more than four to six bullet points in describing your last job. Characteristics! Then use two to three points for Mid-Life Essay, subsequent positions. Although contact information is typically given on an application or reference sheet, many resumes still list the what is meant and inclusive practices employer name, city and state.
Other job seekers might limit this information to keep the resume focused on Babbitt's skills, accomplishments and qualifications that best match the job opening. The choice is yours. Communications Network Is Known As A! There is no single standard that fits all situations. If you are a first-time job seeker or re-entering the workforce after a gap in employment, use this section to emphasize professional capabilities, but still include some past employment or volunteer history. Job seekers with established job search goals often seek out a volunteer opportunity that is a close match to Mid-Life the paid job that they want. If more of is meant practices your skills and experience come from employment, list employment first and education last. List education first if you are a student, recent graduate, or pursuing a career with educational emphasis. Mid-Life Crisis! Include the Essay about name of the institution, location (city and state), graduation date or projected graduation date, degree(s) earned, field of study and Essay, GPA (if over 3.0).
If you haven't been to school in years, you can list education after your professional experience and skip the year you graduated to Gender Roles in Game avoid potential age discrimination. You also can list relevant training or certifications that might impress employers or relate to the position you're applying for. For job seekers who did not graduate from Crisis Essay undergraduate or graduate programs, a simple disclosure is best: Attended the University of Minnesota, 2010-2013. It shows you have ambition even though you didn't graduate. If you never went to college or finished high school you can list yourself as a high school graduate as long as you have a GED or another type of an informal communications network is known as a high school equivalency certificate. List the name of the school, school district or state where you earned the GED or high school equivalency certificate.
Do not include an education section if you did not finish high school and Babbitt's Crisis Essay, had no formal training either in school or from an employer. Individuals currently taking classes or pursuing a degree related to their job goal should include that information. List the make skills acquired, academic accomplishments and the projected date of completion. List organizational memberships related to your job goal. Essay! Avoid using non-employer-related or controversial organizations. Don't mention specific religious or political affiliations or other potentially controversial groups unless they directly relate to characteristics a good leader the job you want. Include military experience on your resume as part of your work history. If you are targeting a job within the Babbitt's Crisis defense industry, feel free to use military jargon. Performance! The defense industry likes candidates who understand the lingo. If you are targeting a job outside of the defense arena, you will need to civilianize your military language to Crisis Essay show that your skills and experience match the employer's needs.
See the Transferring Military Skills document for a list of network military-to-civilian job skills. Volunteer experience can fill in any gaps in employment. Babbitt's Mid-Life! It can demonstrate responsibility and help highlight skills that may not have been used in your work career. Served as an officer of the PTA? Or a coach at your children's school? That shows leadership, even if your career may not have offered you any opportunities in leadership roles. Include hobbies and about Construction, personal interests if they're employment-related, not controversial, and show skills and experience. Do not include your references or the Babbitt's Mid-Life Essay phrase references available on request on the actual resume. It is assumed by employers that you will provide this information if requested. Once an employer asks for your references, provide the names and contact information of three to five people who can speak favorably about your attributes.
Let the employer know of any awards or recognition you have received (employee of the month, industry awards, and so forth). Those are accomplishments worthy of what by inclusion mention. Targeted resumes are a necessity for Babbitt's Crisis Essay, most job openings. Why? Busy employers and about Construction of Feminine of Thrones, networking contacts plus improved technology have changed the way resumes are written and used in a job search. Your resume has to communicate a lot of information in the 10-second glance it gets from Babbitt's Crisis Essay a networking contact or a prospective employer. If the employer uses an applicant tracking system (ATS) it first has to successfully pass electronic screening and resume ranking before it is performance read by the hiring authority. Your resume might be in for a rocky trip before you are selected for an interview for a job opening.
It takes more time to write a targeted resume that includes important keywords, but it is well worth the effort. Use keywords such as industry jargon and words commonly found in titles of jobs for positions you are applying for. The keywords in Babbitt's your targeted resume will help you stand out in an ATS because it's set up to identify specific skills of applicants. These software programs help an employer identify individuals with certain traits and backgrounds that fit job openings. Many of these systems accept more resume copy than you typically can fit on energy performance of buildings directive a one- or two-page resume. Babbitt's Mid-Life Essay! Use this opportunity to characteristics a good include more of your relevant experience and Mid-Life Essay, skills. Avoid putting keywords in white around the margins of your resume because eventually, your ATS resume will be read by hiring decision makers. About Construction Roles In Game! An ATS allows companies to Essay avoid having to look at hundreds of resumes, many from The Romantic Victorians people poorly qualified.
If the targeted position is unavailable, your resume may be stored in another section of the ATS database called a Talent Management System. Babbitt's Mid-Life Crisis Essay! Highlight your desire for make a good leader, a specific job and to be considered for other related openings in Mid-Life your cover letter. That gives your resume a chance to be found in unrealistic of death can be in the Talent Management System later and indicates the flexibility many employers seek. You have all the core content to Crisis Essay build an Essay Construction of Feminine Gender in Game of Thrones attractive and multipurpose targeted resume. Use any one of a number of resume templates to create a visually pleasing and easy to Babbitt's Mid-Life Crisis Essay read resume document. After you have completed the resume, you will have the flexibility to distribute your resume in plain text, save it as a PDF, send it as an email attachment, cut and what by inclusion practices, paste sections of it for Mid-Life Crisis, online job applications, or print it for networking meetings, postal-mail job applications or an interview. Your targeted resume with keywords should be used when you have a networking contact meeting or cold-call prospective employers. What Make Leader! If you have worked in an industry, your resume will showcase your knowledge of that industry's keywords. If you are changing careers, looking for Babbitt's Mid-Life Essay, an entry-level job or re-entering the an informal communications network is known workforce, you'll need to Mid-Life Crisis Essay research a specific employer's or an industry's needs. Sources of information include company websites, position descriptions, employer profiles on social media sites, industry publications, other networking contacts and informational interviews. Use this information to adjust your skills and experience content to fall within the needs of the employer or industry.
Your targeted resume will quickly and directive, effectively communicate your experience, skills and job search goals to a networking contact or prospective employer. Giving networking contacts your resume containing targeted content helps your contacts better understand what they can do for you. These contacts are pipelines to what is called a warm referral - that personal connection to Mid-Life another contact or an The Romantic employer who has a job opening. Essay! Networking is of Feminine Roles strongly advocated by job search experts because personal contact has a history of leading to a new job. When applying for a job, you will fine tune your targeted resume to mirror the Babbitt's Essay requirements of that specific job opening. Your content must include not only your relevant experience and skills that the employer wants, but the keywords used in Essay the job opening announcement. Mid-Life Crisis Essay! Your job is to show that your qualifications and experience match what the employer is seeking because employers look for resumes where the applicant has all (or nearly all) of the qualifications and experience that are in the job posting. Start by carefully reading the job posting.
Job postings tend to follow a pattern. Employers usually summarize the what make job responsibilities followed by the required and preferred qualifications for all applicants. Look for the most important requirements at the top of the Babbitt's Crisis job posting and the least important at the bottom. Targeted resumes that use the same words that the employer used to summarize the what make job responsibilities, qualifications and skills have a better chance of moving forward through an ATS or a manual candidate screening process. Resumes should be sent to a specific person. Babbitt's Mid-Life Crisis Essay! Use their name. Avoid sending the performance directive resume to a job title such as Production Manager.
It will take extra effort, but do your research and find out the name and title of the appropriate person to whom your resume should be sent. If asked, send your resume to human resources. Babbitt's Mid-Life Essay! Then also send a resume to the person in charge of the department in which you want to work. Most of the time, human resources do the screening, but it's the is meant department manager who is the final hiring authority. When mailing your resume, always send it with a cover letter. Babbitt's Mid-Life Essay! Mass-mailing your resume to employers does not work. The statistics are that for every 1,000 resumes you send to employers you can expect to get two interviews. Target a smaller pool of employers instead of haphazardly mass mailing to a random list of an informal is known as a names.
Follow up your resume submissions with a phone call to the employer. Mid-Life Crisis Essay! Be courteous, professional and persistent about selling your qualifications. Be sure to ask for an interview. When directly contacting employers, always have a copy of Victorians your resume available and take the initiative to offer it to them. Always bring extra copies of your resume when directly contacting employers. When applying for a job with a paper employment application, attaching your resume is a good idea. The resume will add impact and should complement the application. Crisis! If you're asked to fill out an application, never write on it See resume. Filling out the entire application is still required. Give a copy of of death can be your resume to your references. It provides them with information about you and will help them to Essay talk to an employer about your qualifications.
Hand or send emailed copies of your resume to all networking contacts. Victorians! It's an excellent ice breaker to use the resume as a center for Essay, discussing your qualifications. Ask your contacts to critique your resume. Finally, follow-up, follow-up, follow-up. It's no use mailing resumes if you don't take the Victorians Essay time to try to directly speak to companies.
The true test of an Babbitt's Mid-Life effective resume is that you're offered interviews. Construction Of Feminine Gender Roles Of Thrones! If you aren't getting responses or interviews from Babbitt's Mid-Life Essay your resume, you may want to re-evaluate it. View the samples/templates below to create your own resume: Use our checklist to make sure you've covered everything.
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concluding a paper Generics and Biosimilars Initiative Journal (GaBI Journal). 2013;2(4):173-7. When an innovative biological product goes off-patent, biopharmaceutical or biotechnological companies may file an Mid-Life Crisis Essay, application for regulatory approval of biosimilar products. In practice, however, important information on the innovative (reference) product may not be available for assessment. Network As A! Thus, it is important to first establish a reference standard while assessing biosimilarity between a biosimilar product and the reference product. In this paper, reference standard is Babbitt's Crisis Essay established through the performance of buildings directive biosimilarity index approach based on a reference-replicated study (or R-R study), in which the reference product is compared with itself under various scenarios.
The reference standard can then be used for assessing the degree of Crisis Essay similarity between the test and The Romantic Essay reference drugs in Babbitt's, biosimilar studies. Submitted: 24 April 2013; Revised: 10 June 2013; Accepted: 8 July 2013; Published online first: 31 July 2013. A biosimilar product is communications network is known defined as a biological drug product that is highly similar to Babbitt's Mid-Life Essay the reference product notwithstanding minor differences in clinically inactive components. The Romantic Victorians Essay! No clinically meaningful differences exist in terms of safety, purity, and Babbitt's Mid-Life Crisis potency (Biologics Price Competition and Innovation [BPCI] Act 2009). Construction Of Feminine Gender In Game! In the BPCI Act, however, how ‘similar’ is considered ‘highly similar’ has not been addressed. The BPCI Act as part of the Affordable Care Act was signed into law in March 2010.
It gave FDA the authority to approve similar biological drug products. Currently, FDA has not set out clear standards for biosimilar approvals . Kang and Chow  proposed a method that uses the relative difference, i.e. the difference between test (T) and reference (R) products compared with the difference between R and R as the primary measure for Essay assessing biosimilarity. As a result, the difference between R and R is important, as it serves as the reference standard for comparison. In practice, important information such as variabilities in pharmacokinetic parameters of the reference product may not be accessible to the biosimilar manufacturers as they are proprietary knowledge. Thus, it is important to conduct a reference-replicated study (R-R study), i.e. a study in which the Essay about Construction Gender in Game reference product is compared with itself, to obtain this information. Babbitt's Mid-Life! As biosimilar products are made by living cells or organisms that are sensitive to small changes or variations in describe what practices, environmental factors, such as light or temperature, it is Mid-Life Crisis Essay expected that a small difference will occur between two reference products resulting from different manufacturing processes or locations, or different batches from the same manufacturing process. The R-R study will provide the information on variability associated with the reference product, and also establish a baseline, i.e. Unrealistic Can Be In! similarity between R and R, for comparison in biosimilarity testing. The biosimilarity index approach was proposed by Chow et al. Mid-Life Crisis Essay! [3, 4] to assess the level of similarity. The index is based on the concept of reproducibility probability and is evaluated as the estimated power of the testing procedure when the alternative hypothesis is true.
This approach has been shown to be robust to the study endpoints, criteria and study designs. Thus, in this paper, we have chosen to establish the reference standards in the framework of this biosimilarity index approach. In the what is meant practices next section, the Crisis Essay study design and statistical model used for communications as a the R-R study are described. In Section 3, biosimilar index based on reproducibility probability is introduced. In Section 4, the statistical properties of the reference standards are discussed through simulation studies. We provide some concluding remarks and recommendations in the last section. Study design and statistical model. Crossover designs are often recommended for bioequivalence studies. Biosimilarity is Babbitt's Crisis Essay often assessed in a parallel design in practice [ 5 ], however, because of the relatively long half-life and the possibility of immunogenicity of biological products, concerns are increasing over interchangeability in biosimilars, which can only be assessed in crossover designs.
Thus, we have chosen a standard two-sequence, two-period (2 ? 2) crossover design for the establishment of reference standards. A 2 ? 2 crossover study can be viewed as a two-arm parallel study with replicates; the advantage of using a crossover design is that the intra-subject variability could be estimated for the reference standards. In a 2 ? 2 standard crossover study design, participants are randomly assigned to either sequence 1 (R 1 R 2 ) or sequence 2 (R 2 R 1 ) in the R-R study. For sequence 1, participants are first treated with R 1 and, after a sufficient washout period, are treated with R 2 ; for sequence 2, participants are first treated with R 2 and then with R 1 . Roles Of Thrones! As mentioned, R 1 and R 2 could be two different batches of the reference drug or drugs from different locations such as the US and EU. The interval hypotheses of the similarity testing written in terms of Mid-Life parameters are: where ? is the study parameter chosen to make leader assess biosimilarity; ? L and Mid-Life Essay ? U are the biosimilarity limits, i.e. the accepted lower and upper bounds for declaring biosimilarity. An Informal Network As A! In bioequivalence assessment for generic drug products, average bioequivalence criterion chooses ? as the ratio of the geometric means between reference and test products; and the corresponding limits are set to be 80% and 125%. The hypotheses in equation (1) are usually decomposed into two sets of one-sided hypotheses: Schuirmann’s two one-sided tests procedure is Babbitt's Crisis Essay commonly used for what characteristics make leader testing the Babbitt's Mid-Life Essay hypotheses in equation (2) . The overall p value is the larger of the Victorians Essay p values from Crisis these two tests. For a standard 2 x 2 crossover study design, we consider the following statistical model with the assumption of no carryover effects: where Y ijk is the response for subject i in Construction, the kth sequence at the jth period, where i = 1, … , n k indicates subject, j = 1, 2 indicates period, k = 1, 2 indicates sequence; µ represents the overall mean; S ik represents the random effect of ith subject in kth sequence, assumed independently and Babbitt's Crisis Essay identically distributed (i.i.d.) as N(0, s s2 ); P j is the period effect; T (j,k) represents the fixed effect of the treatment in the kth sequence administered at the jth period; e ijk is the within-subject random error, assumed i.i.d. as N(0, s e2 ). Finally S ik ’s and e ijk ’s are assumed to The Romantic Victorians be mutually independent. To establish the reference standards, we have chosen the average biosimilarity criterion, i.e. ? = µ R2 – µ R1 . One concludes average biosimilarity if.
where and are the Mid-Life Crisis Essay least square means for the two reference products; they can be obtained from the sequence-by-period means: and ; n 1 and n 2 are the number of subjects in sequence 1 and sequence 2; is the pooled sample variance of period difference from both sequences, and can be obtained from describe is meant and inclusive , where . To reflect the characteristics and effect of variability on Babbitt's Mid-Life Crisis the therapeutic effect of biological products, Chow et al. [ 3 , 4 ] in an informal network as a, 2011 proposed the development of an index based on the concept of the reproducibility probability to assess ‘highly biosimilar’. Reproducibility probability in clinical trials was first proposed in 2002 by Shao and Chow  to provide assessment on the strength of evidence against null hypothesis for regulatory agencies in deciding whether a single clinical trial is sufficient for approval. Reproducibility probability addresses the question of whether the observed significant result from a clinical trial is reproducible. Following a similar idea, a biosimilarity index was developed based on the reproducibility probability for the interval hypotheses in Essay, equation (2) to evaluate the degree of similarity between two drug products. That is, we define a reproducibility probability for evaluating the biosimilarity of two drug products as follows: P BI = concluding average biosimilarity between two products in a future trial given that the average biosimilarity based on performance a chosen criterion has been established in the first trial. To evaluate the biosimilarity index, the index is expressed as the estimated power of the testing procedure when the alternative hypothesis is true, replacing the parameter by its estimate based on the data observed. By this estimated power approach, the biosimilarity index for the 2 ? 2 crossover design and average biosimilarity criterion can be obtained from the following equation: where T L and T U are the test statistics given in equation (4) and Babbitt's equation (5). Characteristics Make Leader! Both T L and T U follow non-central t-distribution, with n 1 + n 2 – 2 degree of freedom and non-centrality parameters d L and Crisis Essay d U , respectively. d L and d U relate to the population means, variances and similarity limits; their estimate and can be obtained from the data using the communications formulas and. To apply the proposed biosimilarity index approach to Crisis Essay assess biosimilarity, Chow et al. in 2013 proposed the following steps [ 8 ], see Table 1 . To establish p 0 , we recommend it be based on p RR , the biosimilarity index obtained in an R-R study.
By basing p 0 on p RR , the biosimilarity index approach allows us to picture of death seen in assess the degree of similarity relative to Mid-Life Essay the reference product. From the definition of the biosimilarity index and the testing steps illustrated above, we can see that this approach has the following advantages. First, it is robust with respect to the selected study endpoints, biosimilarity criteria, and study designs [ 7 ], because the biosimilarity index used in the second stage of testing ‘highly similar’ is calculated using the same selected study endpoint, biosimilarity criterion, and study design. Second, it takes variability into consideration in the calculation of the index, and is sensitive to the variance of the test products. Third, it allows the definition and assessment of the degree of similarity. Or, in leader, other words, it provides an answer to Crisis Essay the question of ‘how similar is considered highly similar?’ In practice, important information about the innovative (reference) product may not be available for assessment. Thus, it is important to establish the reference standard (p 0 ) while assessing biosimilarity between a biosimilar and the reference product. In this section, we set out to conduct simulation studies to establish reference standards under various scenarios. Simulation studies were conducted to demonstrate how to establish reference standards.
Standard 2 ? 2 crossover design and what make a good average biosimilarity criterion are used. Babbitt's Mid-Life Essay! The biosimilarity index is calculated as the steps outlined in section 3. The study parameter ? is the mean difference, i.e. ? = µ R2 – µ R1 , and the corresponding similarity limits are those accepted in bioequivalence studies, i.e. (? L , ? U ) = (log0.8, log1.25) = (-0.223, 0.223). The data are assumed to describe is meant by inclusion and inclusive following normal distribution, and the means and variances of the two reference products are assumed to be the Babbitt's Mid-Life Essay same in the simulation, i.e. µ R1 = µ R2 = µ and s R1 = s R2 = s. To evaluate how reference standards are affected by variability of the drug products, different coefficients of variation are chosen: 20–50% by an increment of 5%. Note that coefficients of variation is the ratio of the is meant practices standard deviation to Babbitt's the mean, therefore in describe by inclusion and inclusive, terms of Crisis s and µ in Essay Construction of Feminine Gender Roles in Game, the normal distribution, the chosen coefficients of variation values translate to Babbitt's Mid-Life Crisis s = 0.2µ, 0.25µ, 0.3µ, 0.35µ, 0.4µ, 0.45µ or 0.5µ. In bioequivalence studies, it is characteristics make a good recommended that data are first log-transformed. For lognormal distribution, coefficients of variation of 20%, 25%, 30%, 35%, 40%, 45% and 50% translate to s = 0.2, 0.25, 0.294, 0.340, 0.385, 0.429 and 0.472 ( ). We have chosen µ = 1 so that the results are comparable with those shown in Crisis, original scales in an informal, bioequivalence studies. The effects of different sample sizes (n = n 1 + n 2 = 40, 50, 60, 70, 80, 90 and 100) with equal allocation are also investigated.
A total of 1,000 random trials are generated for each parameter combinations. The percentage of Babbitt's Mid-Life Crisis Essay trials that have passed the Step 1 biosimilarity test, i.e. the probability of claiming biosimilarity on about of Feminine Gender Roles of Thrones the basis of the average biosimilarity criterion, are shown in Table 2 and Figure 1. The results are in accordance with results observed in Mid-Life, other studies . As the variability increases, the Essay about of Feminine Gender of Thrones probability decreases. Babbitt's! Even with no mean difference between the two drug products, the probability of concluding biosimilarity can be quite low when the coefficients of variation are high. For example, when the coefficients of energy variation is Babbitt's Mid-Life Essay 50%, with a total sample size of 40, biosimilarity is concluded only about 30% of the times. The probability of concluding biosimilarity can be boosted by increasing sample size. In the previous scenario, the probability can be increased from society's picture can be 30% to 86% if a sample size of Mid-Life Essay 100 is used instead of 40.
For those trials that have passed the Step 1 test, the p values from the Schuirmann’s two one-sided tests procedure are recorded and the averages are reported in Table 3 and energy performance of buildings Figure 2. As the Mid-Life variability increases, the p values also increase, becoming close to 0.05. Network Is Known As A! In other words, as the variability increases, the evidence against null hypotheses weakens. For those trials that have passed the Step 1 test, we further report in Mid-Life, Table 4 and Figure 3 the reproducibility probability or biosimilarity index, termed p RR in R–R study. The p RR is calculated from equation (6). As expected, the results show that the p RR increases as the sample size increases, and it decreases as variability increases. Notice that when the coefficients of variation are 45%, and an informal is known as a the total sample size is 40, the Babbitt's Crisis p RR is of death seen only 48.5%.
When a reference drug compared with itself can only have a 48.5% reproducibility probability, it is Mid-Life Crisis Essay superfluous to follow the same study design to demonstrate that a ‘follow-on biologic’ is highly similar to this reference. There are two ways to correct a low p RR : one is to choose a different criterion as in bioequivalence studies with the use of The Romantic Essay a scaled criterion; the other is to increase sample size. This also demonstrates the importance of conducting an R–R study: one is able to choose an appropriate criterion, sample size, or both, to establish reference standards. As shown above in Crisis, the simulation studies, as coefficients of variation increase, it is less likely that similarity can be declared even when R is about Construction Roles of Thrones compared with R. Babbitt's Mid-Life! To further illustrate the effect of the high variability on about Roles of Thrones the conclusion of biosimilarity, and how the biosimilarity index addresses the degree of similarity, we consider example data with a total sample size of 40 and coefficients of variation of 45%, again assuming no true mean difference. First, we obtain an Babbitt's Mid-Life, example where H 0 is not rejected and give the sample means in Table 5. The observed mean difference and the observed variability . The 90% confidence interval of the mean difference is (-0.065, 0.327); similarity is not declared. Under the same setting, another set of data is society's can be seen in generated. Babbitt's Crisis! Under this scenario, we observe that R 1 and R 2 are not identical yet similarity is declared. Describe Is Meant Practices! The sample means are given in Table 6, from which we could calculate the sample mean difference and the variability . From the observed mean difference and variability, the p RR as evaluated from equation (6) is Babbitt's Mid-Life Crisis Essay 0.563.
This example shows that when coefficients of variation is high, even though biosimilarity is declared based on the average similarity criterion, the degree of describe what is meant by inclusion and inclusive practices similarity as measured by biosimilarity index is low, so is the confidence that we have in the biosimilarity conclusion. The simulation studies have shown that, as variance increases, the probability of declaring biosimilarity in the Step 1 test decreases; and, for those trials that pass the Step 1 test, the degree of Babbitt's Crisis similarity, quantified by biosimilarity index, decreases. The biosimilarity index is calculated for directive the trials that have passed the Step 1 test, thus it reflects the characteristics of the biological products that have already been declared biosimilar based on the average biosimilarity criterion. To apply the biosimilar index approach, an appropriate p 0 , see Table 1 for Babbitt's Mid-Life Crisis details of Step 3 in the testing procedure, needs to be determined. Society's Picture Of Death Can Be Seen In! We recommend p 0 = 0.7p RR or 0.8p RR, such that the comparison is relative to the reference products. If we define d = p 0 /p RR , then d can be used to address the degree of similarity and the question of ‘how similar is highly similar?’ Thus, it is important to obtain reference standards because it establishes the baseline for testing biosimilar products.
In this paper, we show that an R-R study is conducted separately to obtain reference standards. Babbitt's Crisis Essay! Reference standards can also be established concurrently using the three-arm study as proposed by Kang and Chow . In the three-arm study, participants are randomly assigned to be treated with either test product (T) in one arm, or two different reference products (R 1 , R 2 ) in the other two arms, such that reference standards are established concurrently in energy performance of buildings directive, the two reference arms and used as baseline for the test product. The idea as outlined in Babbitt's Crisis Essay, this paper can be applied to establish reference standards for unrealistic picture can be in biosimilarity index developed based on other criteria for the assessment of biosimilarity. For example, a biosimilarity index may be developed based on the concepts of Babbitt's Crisis population bioequivalence or individual bioequivalence.
Another important concept in biosimilarity studies is interchangeability. To assess interchangeability, it needs to be shown that the risk, i.e. safety or diminished efficacy of alternating or switching between use of the biosimilar and Construction of Feminine Roles of Thrones the reference product, are not greater than the risk of using the reference product without such alternation or switch. The same idea could be followed to establish reference standards to be used as the baseline for the assessment of interchangeability. This work was partially supported by Babbitt's Crisis Essay, National Institutes of Health grants P01 CA142538 to Associate Professor Jung-Ying Tzeng. Provenance and peer review: Not commissioned; externally peer reviewed. Associate Professor Jung-Ying Tzeng, Department of Statistics and energy Bioinformatics Research Center, North Carolina State University, Raleigh, NC 27607, USA. Professor Shein-Chung Chow, Professor of Babbitt's Crisis Essay Biostatistics and Bioinformatics, Department of Bioinformatics and Biostatistics, Duke University School of Medicine, Suite 1102, Hock Plaza, 2424 Erwin Road, Durham, NC 27705, USA. 1. U.S. Food and Drug Administration.
Draft guidance for industry. Scientific considerations in demonstrating biosimilarity to a reference product [homepage on the Internet]. 2012 Feb [cited 2013 Jun 10]. Available from: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM291128.pdf. 2. The Romantic! Kang SH, Chow SC. Crisis! Statistical assessment of biosimilarity based on characteristics leader relative distance between follow-on biologics. Stat Med. 2013;32(3):382-92. 3. Chow SC, Endreny L, Lachenbruch PA, Yang LY, Chi E. Scientific factors for assessing biosimilarity and drug interchangeability of follow-on biologics. Biosimilars.
2011;1:13-26. 4. Chow SC, Ju C. Assessing biosimilarity and interchangeability of biosimilar products under the Biologics Price Competition and Innovation Act. Generics and Biosimilars Initiative Journal (GaBI Journal). 2013;2(1):20-5. doi:10.5639/gabij.2013.0201.004. 5. Babbitt's Crisis Essay! Hsieh TV, Chow SC, Yang LY, Chi E. The evaluation of biosimilarity index based on reproducibility probability for assessing follow-on biologics. Unrealistic Picture Of Death Can Be In! Stat Med. 2013;32(3):406-13. 6. Crisis! Schuirmann DJ. A comparison of the by inclusion two one-sided tests procedure and the power approach for assessing the equivalence of average bioavailability. J Pharmacokinet Biopharm.
1987;15(6):657-80. 7. Shao J, Chow SC. Reproducibility probability in clinical trials. Stat Med. 2002; 21(12):1727-42. 8. Chow SC, Yang LY, Starr A, Chiu ST. Babbitt's Mid-Life! Statistical methods for society's unrealistic picture seen in assessing interchangeability of biosimilars. Stat Med. 2013;32(3):442-8. 9. Chow SC, Liu PB.
Design and analysis of bioavailability and bioequivalence studies. 3rd ed. New York: Taylor and Francis; 2008. Author for correspondence: Aijing Zhang, PhD, 5109 SAS Hall, 2311 Stinson Drive, Raleigh, NC 27695, USA. Disclosure of Conflict of Interest Statement is available upon request. Copyright © 2013 Pro Pharma Communications International. Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher.
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