Bioequivalence Testing - Industry Perspective
نویسندگان
چکیده
منابع مشابه
Bioequivalence and Bioequivalency Testing
PROLOGUE This lecture material is covered in one and one-half fiftyminute lecture periods. The primary objectives of the lecture are to: (i) review interpatient and intrapatient pharmacokinetic variability; (ii) introduce the concepts of therapeutic equivalence and bioequivalence; (iii) introduce the current FDA standards on bioequivalence; (iv) introduce the basic approach of bioequivalency te...
متن کاملIn vitro bioequivalence testing.
A statistical test is proposed for in vitro bioequivalence testing between drug products such as nasal aerosols and nasal sprays. The proposed test generalizes the one recommended in the FDA 1999 guidance to the situation where replicated observations obtained from each sampled canister or bottle of the drug product are available. The technique developed by Hyslop, Hsuan and Holder is used so t...
متن کاملIn vivo and In vitro Bioequivalence Testing
For approval of generic drug products, bioequivalence testing is considered as a surrogate for clinical evaluation of the therapeutic equivalence of drug products based on the Fundamental Bioequivalence Assumption that when two drug products (e.g., a brand-name drug and its generic copy) are equivalent in bioavailability, they will reach the same therapeutic effect. Although bioavailability for...
متن کاملBioequivalence Approach for Whole Effluent Toxicity Testing
Increased use of whole effluent toxicity (WET) tests in the regulatory arena has brought increased concern over the statistical analysis of WET test data and the determination of toxicity. One concern is the issue of statistical power. A number of WET tests may pass the current hypothesis test approach because they lack statistical power to detect relevant toxic effects because of large within-...
متن کاملIndividual bioequivalence testing under 2x3 designs.
In recent years, as more generic drug products become available, it is a concern not only whether generic drug products that have been approved based on the regulation of average bioequivalence will have the same quality, safety and efficacy as that of the brand-name drug product, but also whether the approved generic drug products can be used interchangeably. In its recent draft guidance, the ...
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: Journal of Bioequivalence & Bioavailability
سال: 2010
ISSN: 0975-0851
DOI: 10.4172/jbb.1000039