Guidances related to bioavailability and bioequivalence: European industry perspective

Author:

Ahr Gertrud,Voith Barbara,Kuhlmann Jochen

Publisher

Springer Science and Business Media LLC

Subject

Pharmacology (medical),Pharmacology

Reference5 articles.

1. Rowland M., Tozer T.N. (1995): Clinical Pharmacokinetics, Concepts and Applications, 3rd edn. London: Williams & Wilkins.

2. Amidon G.L., Lennernäs H., Shah V.P., Crison J.R. (1995): Pharm. Res., 12, 413–420.

3. Gleiter C.H., Klotz U., Kuhlmann J. et al. (1998): J. Clin. Pharm., 38, 908–911.

4. FDA Guideline: In vivo Bioequivalence studies based on Population and Individual Bioequivalence Approaches.

5. CPMP Guideline: Note for Guidance on the Investigation of Bioavailability and Bioequivalence.

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