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Generic Drug Product Development: Solid Oral Dosage Forms, Second Edition

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Generic Drug Product Development: Solid Oral Dosage Forms, Second Edition - Shargel, Leon, PhD, Rph (Editor), and Kanfer, Isadore (Editor)
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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 ...

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Generic Drug Product Development: Solid Oral Dosage Forms, Second Edition 2013, CRC Press, Oxford

ISBN-13: 9781420086355

2nd edition

Hardcover