Bioavailability and bioequivalence studies for orally administered drug products—general considerations
by FDA Center for Drug Evaluation and Research
This white paper by the Food and Drug Administration's Center for Drug Evaluation and Research (CDER) provides recommendations to sponsors and/or applicants planning to include bioavailability (BA) and bioequivalence (BE) information for orally administered drug products in investigational new drug applications (INDs), new drug applications (NDAs), abbreviated new drug applications (ANDAs), and their supplements. This paper contains advice on how to meet the BA and BE requirements set forth in 21 CFR Part 320 as they apply to dosage forms intended for oral administration. This paper revises the October 2000 guidance recommendations regarding study design and dissolution methods development, comparisons of BA measures, the definition of proportionality and waivers for bioequivalence studies.
| Published: | 2003 |
| Format: | |
| Length: | 26 pages |
| Type: | White paper |
| Language: | English |
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