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Biowaiver Monograph 2004-2012

Regulations on biowaivers already existed at that time, according to which an in vitro instead of an in vivo assessment could be used to assess bioequivalence for a new tablet or capsule, or a new formulation of an existing immediate release dosage form. On the basis of the in vitro assessment, a new drug product could be considered bioequivalent to its reference product, without having to perform a pharmacokinetic study in human volunteers. To generally describe the use of an in vitro assessment to waive the need for in vivo (bio) studies, the term biowaiver was coined. As this term was originally applied to waiving in vivo studies for registration of lower dosage strengths of drug products, the more precise term "BCS based biowaiver" is sometimes used to distinguish biowaivers based on BCS considerations from biowaivers used for the approval of lower dose strengths of a product.

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About Us

PT. Pharma Test Indonesia was established at the end of 2009. We are the subsidiary of Pharma Test AG (Germany) in South East Asia which supplies machines for Pharmaceutical Industry. As a part of Pharma Test commitment to Indonesian market, the company was established to fulfill the need for high quality testing equipments and supported with excellent after-sales service. Our company also supported the Pharma Test agents in South East Asia especially for the technical support.

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PT. Pharma Test Indonesia
Rukan Crown Blok A No.8
Green Lake City
Tangerang 15147
Indonesia

Phone: +6221 54318816
Mobile. +62 851 00902797

Marketing: hans@pharma-test-indo.com
Technical Support: teknik@pharma-test-indo.com

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