ETHICAL GUIDELINES AND STUDY DESIGN FOR BIOAVAILABILITY AND BIOEQUIVALENCE STUDY
Abstract
Unusual growth in pharma industry has provoked regulatory agencies to establish regulations regarding bioavailability (BA) and bioequivalence
(BE) studies. The BA and BE testing are essential in drug development process, provides the information regarding the kinetics (area under the curve
[AUC], C
max
, T
max
, λ
z
, t
½
, AUC
0→Tss,
C
maxss
, C
minss
, C
avgss
, T
) of single and multiple dose studies and the comparison of medicinal products. Indian Council
of Medical Research (ICMR), Committee for the Purpose of Control and Supervision of Experiments on Animals (CPCSEA), Indian National Science
Academy (INSA), Institutional Animal Care and Use Committee Guidebook (IACUC), National Institutes of Health, Food and Drug Administration,
World Health Organization (WHO) provides the informations for strengthening the ethical guidelines for using humans and animals in clinical trials
globally. Experimental design will help for better selection of models, number of subjects/animals, study conditions, randomizations, selection of
control groups. Statistical evaluation parameters like Analysis of Variance help for the better interpretation of the data. The present study was aimed
to study the need for BA and BE studies, ethical guidelines, experimental designs, pharmacokinetic endpoints, and their statistical evaluations.
maxss
Keywords: Ethical guidelines, Study design, Bioavailability, Bioequivalence.
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