This is a preview of subscription content, log in via an institution to check access.
References
Sheiner L.B. (1997): Learning versus confirming in clinical drug development. Clin. Pharmcol. Ther., 61, 275–291.
US Department of Health and Human Services, Food and Drug Administration. (1999): 21 CFR 320.1, Office of the Federal Register, National Archives and Records Administration.
Rowland M., Tozer T.N. (1995): Clinical Pharmacokinetics: Concepts and Applications, 3rd edn. Media, PA: Williams & Wilkins.
US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research. (1999): Draft Guidance for Industry: BA and BE studies for orally administered drug products — general considerations. (Internet) http://www.fda.gov/cder/guidance/index.htm.
International Conference on Harmonization (ICH). (1999): Q6A specifications: test procedures and acceptance criteria for new drug substances and new drug products: chemical substances. (Internet) http://www.ifpma.org/ich1.htm.
US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research. (1999): Approved drug products with therapeutic equivalence evaluations (The Orange Book), 19th edn. Office of Information Technology, Division of Database Management and Services.
Endrenyi L., Fritsch S., Yan W. (1991): Cmax/AUC is a clearer measure than Cmax for absorption rates in investigations of bioequivalence. Int. J. Clin. Pharmacol. Ther. Toxicol., 29, 394–399.
Chen M.L. (1992): An alternative approach for assessment of rate of absorption in bioequivalence studies. Pharm. Res., 9, 1380–1385.
Bois F.Y., Tozer T.N., Hauck W.W., Chen M.L., Patnaik R., Williams R. (1994): Bioequivalence: Performance of several measures of rate of absorption. Pharm. Res., 11, 966–974.
Lacey L.F., Keene O.N., Duquesnoy C., Bye A. (1994): Evaluation of different indirect measures of rate of drug absorption in comparative pharmacokinetic studies. J. Pharm. Sci., 83, 212–215.
Rostami-Hodjegan A., Jackson P.R., Tucker G.T. (1994): Sensitivity of indirect metrics for assessing ‘rate’ in bioequivalence studies — moving the ‘goalposts’ or changing the ‘game’. J. Pharm. Sci., 83, 1554–1557.
Tothfalusi L., Endrenyi L. (1995): Without extrapolation, Cmax/AUC is an effective metric in investigations of bioequivalence. Pharm. Res., 12, 937–942.
Tozer T.N., Bois F.Y., Hauck W.W., Chen M.L., Williams R.L. (1996): Absorption rate vs. exposure: which is more useful for bioequivalence testing? Pharm. Res., 13, 453–456.
Endrenyi L., Csizmadia F., Tothfalusi L., Balch A., Chen M.L. (1997): The duration of measuring partial AUCs for the assessment of bioequivalence. Pharm. Res., 15, 399–404.
US Department of Health and Human Services, Food and Drug Administration. (1999): 21 CFR 320.24, the Office of the Federal Register, National Archives and Records Administration.
Singh G.J.P., Adams W.P., Lesko L.J. et al. (1999): Development ofin vivo bioequivalence methodology for dermatologic corticosteroids based on pharmacodynamic modeling. Clin. Pharmacol. Ther., 66, 346–357.
US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research. (1999): Draft Guidance for Industry: Waiver ofin vivo bioavailability and bioequivalence studies for immediate release solid oral dosage forms containing certain active moieties/active ingredients based on a biopharmaceutics classification system. (Internet) http://www.fda.gov/cder/guidance/index.htm.
US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (1992): Guidance on statistical procedures for bioequivalence studies usings standard two-treatment crossover design. (Internet) http://www.fda.gov/cder/guidance/index.htm.
Chen M.L., Patnaik R., Hauck W.W., Schuirmann D.J., Hyslop T., Williams R.L. (1999): Individual bioequivalence criterion: Regulatory considerations. Stat. Med., In press.
European Court of Justice, Case C-368/96, 3 December 1998.
Federal Register. (1997): 62; 14917–14918.
US Department of Health and Human Services, Food and Drug Administration, International Conference on Harmonization (ICH). (1998): E5 Ethnic factors in the acceptability of foreign clinical data. (Internet) http://www.fda.gov/cder/guidance/index.htm.
Sheiner L.B. (1991): The intellectual health of clinical drug evaluation. Clin. Pharmacol. Ther., 50, 4–9.
Steinijans V.W., Hartmann M., Huber R., Radtke H.W. (1991): Lack of pharmacokinetic interaction as an equivalence problem. Int. J. Clin. Pharmacol. Ther., 29, 323–328.
Williams R.L. (1998): Early phase clinical studies: a regulatory perspective. Clinical Development of New Drugs and Therapeutic Agents: Art, Science, and New Frontiers, Center for Drug Development Science, Georgetown University, May 15, 1998.
World Health Organization (1999): Guidance on the selection of the comparator pharmaceutical product for equivalence assessment of interchangeable multi-source (generic) products. Geneva: WHO, In press.
Author information
Authors and Affiliations
Consortia
Rights and permissions
About this article
Cite this article
Williams, R.L., Adams, W., Chen, ML. et al. Where are we now and where do we go next in terms of the scientific basis for regulation on bioavailability and bioequivalence?. Eur. J. Drug Metab. Pharmacokinet. 25, 7–12 (2000). https://doi.org/10.1007/BF03190049
Issue Date:
DOI: https://doi.org/10.1007/BF03190049