Bioanalytical Method Development and Validation of Biosimilars: Lessons Learned
نویسندگان
چکیده
منابع مشابه
Bioanalytical Method Development and Validation of Biosimilars: Lessons Learned
[1]. In order to evaluate biosimilarity between an innovator and biosimilar product, the FDA recommended a stepwise, riskbased totality of evidence approach. In addition to extensive structural and functional characterization, effort must also be made on preclinical development in terms of animal toxicity studies and the assessment of pharmacokinetics (PK) and immunogenicity. Although there are...
متن کاملBioanalytical challenges of biosimilars.
Biologics such as monoclonal antibodies and recombinant proteins represent a significant portion of the pharmaceutical market. With many of the first generation biologics' patents expiring, an increasing number of biosimilars will be submitted for approval in the near future. The successful development of a biosimilar requires the demonstration of biosimilarity in terms of efficacy, safety and ...
متن کاملBioanalytical method validation
A syntetic discussion on bioanalytical methods validation is presented from the point of view of regulatory documents, scientific articles and books. The validation parameters are described, together with an example of validation methodology applied in the case of chromatographic methods used in bioanalysis, taking in account to the recent Food and Drug Administration (FDA) guidelines and docum...
متن کاملBioanalytical Method Development and Validation of Capecitabine by RP-HPLC Method
A rapid high-performance liquid chromatographic bioanalytical method has been developed and validated for capecitabine in human plasma. Capecitabine a prodrug of 5-fluorouracil (5-FU), is an oral tumor – selective fluoro pyrimidine carbamate approved in the treatment of colorectal and breast cancer. Capecitabine was found with symmetrical peak shapes on an analytical column, Phenomenex Luna C18...
متن کاملBioanalytical Method Development and Validation of Lamivudine by Rp-hplc Method
A simple, accurate, precise and sensitive HPLC method with UV detection was developed and validated to separate and detect lamivudine in human plasma using Stavudine as an internal standard.Lamivudine (3-TC) and Stavudine (internal standard) were extracted from human plasma using methanol protein precipitation and were chromatographed on a Phenomenex C18 (250X4.6mm.,5mμ particle size) column us...
متن کاملذخیره در منابع من
با ذخیره ی این منبع در منابع من، دسترسی به آن را برای استفاده های بعدی آسان تر کنید
ژورنال
عنوان ژورنال: MOJ Immunology
سال: 2014
ISSN: 2373-4442
DOI: 10.15406/moji.2014.01.00004