Success for generic drug companies is dependent on their ability to manufacture therapeutic-equivalent drug products in an economical and timely manner, while also being cognizant of patent infringement and other legal and regulatory concerns. In this volume, more than 30 noted specialists describe the development of generic drug products--from the raw materials to the development of a therapeutic-equivalent drug product to regulatory approval. This second edition includes discussion on the relationship between the FDA and ...
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Success for generic drug companies is dependent on their ability to manufacture therapeutic-equivalent drug products in an economical and timely manner, while also being cognizant of patent infringement and other legal and regulatory concerns. In this volume, more than 30 noted specialists describe the development of generic drug products--from the raw materials to the development of a therapeutic-equivalent drug product to regulatory approval. This second edition includes discussion on the relationship between the FDA and the United States Pharmacopeia and the application of Quality by Design (QbD) during formulation development.
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Add this copy of Generic Drug Product Development: Solid Oral Dosage to cart. $244.24, new condition, Sold by Ingram Customer Returns Center rated 5.0 out of 5 stars, ships from NV, USA, published 2013 by CRC Press.
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Seller's Description:
New. Sewn binding. Cloth over boards. 397 p. Contains: Unspecified, Illustrations, black & white, Tables, black & white. Drugs and the Pharmaceutical Sciences.
