Drug product classification

Amidon, G. L., Lennemas, H., Shah, V. P., Crison, J. R. A. A theoretical basis for a biopharmaceutic drug classification the correlation of in vitro drug product dissolution and in vivo bioavailability. Pharm. Res. 1995, 12, 413 20. 

The BCS also predicts the possibility of obtaining an in vitro/in vivo correlation. Justification of a biowaiver is based on a combination of the BCS classification of the drug substance and a drug product dissolution profile comparison. In all these instances, an anchor with a bioavailable product is established. Specifically, to obtain a biowaiver for an IR generic product ... 

Amidon GL, Lennernas H, Shah VP and Crison JR (1995) A Theoretical Basis for a Biopharmaceutic Drug Classification The Correlation In Vitro Drug Product Dissolution and In Vivo Bioavailability. Pharm Res 12 pp 413-420. 

Convention, Inc., which also publishes the USP (United States Pharmacopeia). The purpose of the NF is to ensure the uniformity of drug products and to maintain and upgrade standards of drug quality, packaging, labeling, and storage. In 1980, all NF responsibility for white oil classification was transferred to the USP. 

The investigator is generally not permitted to include any observations on the FDA-483 relating to labels, promotional materials, product classifications (new drug application [NDA], premarket application [PMA], etc.), or registration requirements. It is not inappropriate to ask why such observations are included on an FDA-483. It could be an error that could result in either removal of the observation or clarification that headquarters has approved its inclusion. 

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