Bioanalytical method development: considering information from a suite of complementary methods

Bioanalytical Method Development Strategy for Therapeutic Peptides

Bioanalytical Methods in Toxicology

Elżbieta Skrzydlewska Department of Analytical Chemistry, Medical University of Białystok15-230 Białystok 8, P. O. Box 14, Poland The goal of this Special Issue on Bioanalytical Methods in Toxicology is to recapitulate the latest achievements concerning the theory and practice of modern chromatography and related techniques. The interest of such significant and current issues has not been accid...

a paradigm shift away from method-wise teaching to strategy-wise teaching: an investigation of reconstructive strategy versus communicative strategy

چکیده: هدف اصلی این مطالعه ی توصیفی تحقیقی در حقیقت تلاشی پساروش-گرا به منظور رسیدن به نتیجه ای منطقی در انتخاب مناسبترین راهکار آموزشی بر گرفته از چارچوب راهبردی مطرح شده توسط والدمر مارتن بوده که به بهترین شکل سازگار و مناسب با سامانه ی آموزشی ایران باشد. از این رو، دو راهکار آموزشی، راهکار ارتباطی و راهکار بازساختی، برای تحقیق و بررسی انتخاب شدند. صریحاً اینکه، در راستای هدف اصلی این پژوهش، ر...

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...

Bioanalytical 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...