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- Title
Pharmacokinetic studies for proving bioequivalence of orally inhaled drug products--critical issues and concepts.
- Authors
Thakkar, Karan; Mhatre, Suyog; Jadhav, Manish; Goswami, Sailendra; Shah, Rajen; van Koppen, Chris J.
- Abstract
The article presents author's comments on the in-vitro and invivo- pharmacokinetic (PK) studies, that prove bioequivalence of inhaled drugs which plays an important role in ensuring substitutability of generics, when the in-vitro data and pharmaceutical data. It offers information on the prove bioequivalence of orally inhaled drug products (OIDPs), and dynamic (PD) studies.
- Subjects
PHARMACOKINETICS; GENERIC drugs; THERAPEUTIC equivalency in drugs; PHARMACEUTICAL industry; IN vivo toxicity testing
- Publication
Frontiers in Pharmacology, 2015, p1
- ISSN
1663-9812
- Publication type
Opinion
- DOI
10.3389/fphar.2015.00117