Generic drug product development: solid oral dosage forms

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"This book collects in-depth discussions from more than 30 noted specialists on topics such as quality control, experimental formulations, pharmaceutical ingredients, conventional and modified-release products, and bioequivalence. It considers key elements in the formulation of generic drug products including the availability of raw materials and chemical purity. It contains new chapters on experimental formulation development, and the relationship between the FDA and the United States Pharmaco…

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Title Statements

Full title :Generic drug product development : solid oral dosage forms / edited by Leon Shargel, Isadore Kanfer.

Summary

Edition Statements

Publication Date:2014.
Edition:2nd ed

Publication Statements

Publisher(s):CRC Press/Taylor & Francis Group
Place of Publication:Boca Raton, Fla
Language:eng
Publication Date:2014.

The Physical Object

Description:1 online resource (xii, 385 p.) : : illustrations.

Edition Identifiers

ISBN:9781420086362, 1420086367
oclc:ocn941218447

Ch. 1. Generic drug product development and therapeutic equivalence / Leon Shargel and Isadore Kanfer -- ch. 2. Active pharmaceutical ingredients / Edward M. Cohen and Steven Sutherland -- ch. 3. Analytical methods development and methods validation for oral solid dosage forms / Quanyin Gao and Dilip R. Sanvordeker -- ch. 4. Experimental formulation development / Isadore Kanfer ... [et al.] -- ch. 5. Scale-up, technology transfer, and process performance qualification / Salah U. Ahmed ... [et al.] -- ch. 6. Drug stability / Pranab K. Bhattacharyya -- ch. 7. Quality control and quality assurance / Loren Gelber -- ch. 8. Drug product performance : in vitro / Pradeep M. Sathe, John Duan, and Lawrence X. Yu -- ch. 9. ANDA regulatory approval process / Timothy W. Ames and Aaron Sigler -- ch. 10. Bioequivalence and drug product assessment : in vivo / Barbara M. Davit and Dale P. Conner -- ch. 11. Statistical considerations for establishing bioequivalence / Charles Bon and Sanford Bolton -- ch. 12. Outsourcing bioavailability and bioequivalence studies to contract research organizations / Patrick K. Noonan -- ch. 13. Postapproval changes and postmarketing reporting of adverse drug experi…

Subjects

Chimie pharmaceutique Comprimés Drug Approval Generic drugs Médicaments -- Autorisation de mise sur… Médicaments génériques Pharmaceutical chemistry Tablets (Medicine)