Within-subject pharmacokinetic variability has a strong influence on individual exposure ratios in bioequivalence studies, hence on drug formulation interchangeability

Author:

Lechat Philippe,Kir Fatma,Marquet Pierre,Woillard Jean-Baptiste

Publisher

Springer Science and Business Media LLC

Subject

Pharmacology (medical),Pharmacology,General Medicine

Reference18 articles.

1. Berg MJ, Gross RA, Tomaszewski KJ, Zingaro WM, Haskins LS (2008) Generic substitution in the treatment of epilepsy: case evidence of breakthrough seizures. Neurology 71:525–530

2. Dernières données issues de l'enquête de pharmacovigilance de l'ANSM sur les médicaments à base de lévothyroxine. https://ansm.sante.fr/actualites/medicaments-a-base-de-levothyroxine-lansm-publie-les-dernieres-donnees-issues-de-lenquete-de-pharmacovigilance. Accessed 30 Mar 2023

3. EMA guideline on the investigation of bioequivalence: Guideline o the Investigation of Bioequivalence (europa.eu). Accessed 30 Mar 2023

4. EMA: Questions and answers on bioequivalence studies. https://www.ema.europa.eu/en/human-regulatory/research-development/scientific-guidelines/clinical-pharmacology-pharmacokinetics/clinical-pharmacology-pharmacokinetics-questions-answers. Accessed 30 Mar 2023

5. FDA Guidance for Industry Bioavailability and Bioequivalence Studies Submitted in NDAs or INDs — General Considerations. https://www.fda.gov/files/drugs/published/Bioavailability-and-Bioequivalence-Studies-Submitted-in-NDAs-or-INDs-%E2%80%94-General-Considerations.pdf. Accessed 30 Mar 2023

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