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Bioequivalence Studies in Drug Development
Language: en
Pages: 328
Authors: Dieter Hauschke
Categories: Medical
Type: BOOK - Published: 2007-02-27 - Publisher: Wiley

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Studies in bioequivalence are the commonly accepted method to demonstrate therapeutic equivalence between two medicinal products. Savings in time and cost are s
Generic Drug Product Development
Language: en
Pages: 334
Authors: Isadore Kanfer
Categories: Medical
Type: BOOK - Published: 2016-04-19 - Publisher: CRC Press

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Due to a worldwide need for lower cost drug therapy, use of generic and multi-source drug products have been increasing. To meet international patent and trade
Applied Biopharmaceutics and Pharmacokinetics
Language: en
Pages: 625
Authors: Leon Shargel
Categories: Biopharmaceutics
Type: BOOK - Published: 1993 - Publisher: McGraw-Hill/Appleton & Lange

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Bioequivalence and Statistics in Clinical Pharmacology
Language: en
Pages: 461
Authors: Scott D. Patterson
Categories: Mathematics
Type: BOOK - Published: 2017-03-27 - Publisher: CRC Press

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Maintaining a practical perspective, Bioequivalence and Statistics in Clinical Pharmacology, Second Edition explores statistics used in day-to-day clinical phar
FDA Bioequivalence Standards
Language: en
Pages: 472
Authors: Lawrence X. Yu
Categories: Medical
Type: BOOK - Published: 2014-09-05 - Publisher: Springer

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This comprehensive reference provides an in-depth discussion on state-of-the-art regulatory science in bioequivalence. In sixteen chapters, the volume explores