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Biopharmaceutics is a scientific discipline that examines the interrelationship of the physicochemical properties of the drug, the dosage form in which the drug is given, and the route of administration on the rate and extent of systemic drug absorption ( Applied Biopharmaceutics and Pharmacokinetics, Shargel, Wu-Pong and Yu, 5th Edition ).
Ultimately, the summary was not adopted during the QbD pilot, but was reintroduced in 2014 when a Pharmaceutical Research and Manufacturers of America (PhRMA) team prepared a whitepaper describing the content and format of an improved Module 2. The results of the risk assessment are used to define experiments.
Ultimately, the summary was not adopted during the QbD pilot, but was reintroduced in 2014 when a Pharmaceutical Research and Manufacturers of America (PhRMA) team prepared a whitepaper describing the content and format of an improved Module 2. The results of the risk assessment are used to define experiments.
Examples include platforms as small as autonomous units placed within a facility and mobile production trailers for compounding to platforms as large as a prefabricated, self-contained GMP facility. POD is suitable for a wide range of products, including oral solid dosage forms, mAbs, and cell therapy. doi:10.1016/j.jbiotec.2015.06.388
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