Bioequivalence testing of immunosuppressants: concepts and misconceptions

Anne Anastasi Psychological Testing : Basic Concepts and Common Misconceptions

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...

In 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...

In 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...

Concepts and fuzzy sets: Misunderstandings, misconceptions, and oversights

The psychology of concepts has been undergoing significant changes since the early 1970s, when the classical view of concepts was seriously challenged by convincing experimental evidence that conceptual categories never have sharp boundaries. Some researchers recognized already in the early 1970s that fuzzy set theory and fuzzy logic were potentially suitable for modeling of concepts and obtain...