HANDBOOK OF GENERIC DRUG DEVELOPMENTH ANDBOOKDRUG DEVELOPMENTofPharmaceutical

Generic Development
Controlled Release

Oral Tablets
Pharmaceutical Drug Development

VOLUME I0 - Part One
DRUG Development - Solid CR Oral Dosage Forms

DRUG DEVELOPMENTHANDBOOK OF GENERIC DRUG DEVELOPMENTDRUG DEVELOPMENTHANDBOOK OF GENERIC DRUG DEVELOPMENTDRUG DEVELOPMENTThe Complete H a n d b o o k S e r i e s o f
Pharmaceutical Drug Development
ISBN 0793 8632 - Electronic Version
Handbook Development 24 Volume Series
ISSN Series Number 0793 761X - Electronic Version

Handbook of Pharmaceutical Generic Development
Part I (Development) & Part II (Development ANDA or EU Dossier)Handbook of Pharmaceutical Generic Development
Part I (Development) & Part II (Development ANDA or EU Dossier)Handbook of Pharmaceutical Generic Development
Part I (Development) & Part II (Development ANDA or EU Dossier)Handbook of Pharmaceutical Generic Development
Part I (Development) & Part II (Development ANDA or EU Dossier)Handbook of Pharmaceutical Generic Development
Part I (Development) & Part II (Development ANDA or EU Dossier)Handbook of Pharmaceutical Generic Development
Handbook of Pharmaceutical Generic Development
Part I (Development) & Part II (Development ANDA or EU Dossier)Handbook of Pharmaceutical Generic Development
Part I (Development) & Part II (Development ANDA or EU Dossier)Handbook of Pharmaceutical Generic Development
Part I (Development) & Part II (Development ANDA or EU Dossier)Handbook of Pharmaceutical Generic Development
Part I (Development) & Part II (Development ANDA or EU Dossier)Handbook of Pharmaceutical Generic Development
Part I (Development) & Part II (Development ANDA or EU Dossier)Handbook of Pharmaceutical Generic Development
Part I (Development) & Part II (Development ANDA or EU Dossier)Handbook of Pharmaceutical Generic Development
Part I (Method Validation) & Part II (Analytical Methods 1994-2003)

Handbook of Pharmaceutical Innovative Development
Handbook of Pharmaceutical Innovative Development
Handbook of Pharmaceutical Innovative Development
Handbook of Pharmaceutical
Drug Development(Master Formula & Manufacturing Instructions Parts 1 - 5)

Handbook of PharmaceuticalVol. 1 - Tablets Oral
Vol. 2 - Capsules Oral
Vol. 3 - Semisolids
Vol. 4 - Liquids Oral
Vol. 5 - SG Capsules
Vol. 6 - e-SOPs / SOPs
Vol. 7 - Suspensions
Vol. 8 - Eye & NoseVol. 9 - Aerosols MDI
Vol. 10 -Tablets CR/MR
Vol. 11 -Capsules ER
Vol. 12 - Tablets Oral DRVol. 13 - Analytical (Top50 Generic Assay Methods)

Vol. 14 - Tablets Oral
Vol. 15 - Capsules Oral
Vol.16 Suspensions Oral
Vol. 17 - MF and MMI

Drug Development Vol. 18 - MF and MMI(Master Formula & Manufacturing Instructions Parts 6 -10)

Handbook of Pharmaceutical Innovative Development
Part I, II & III (Development, Manufacturing & Engineering)

Handbook of Pharmaceutical Drug Development
Part I (Development) & Part II (Development ANDA or EU Dossier)Vol. 19-SOPs/PAI-Checklist
Vol. 20 - Sterile Injections

Available as Print, Online, CD ROM or electronic mail attachment. Additional Drug Specific Volumes in Preparation.
Pentoxifylline ER; Gabapentin ER, Glipizide ER; Felodipine ER; Naproxen DR; Sinemet ER.
An on-going electronic and print series. Available either as Hard Bound, Soft Bound or Soft Spiral Cover (for Updating).
For Drug Specific Handbooks refer to the 120+ Drug Development Series titled
READY-TO-GO™ DRUG DEVELOPMENT SERIES

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HPGD Series CR Tablets Oral - Part I.
First International Edition - 01. First published and distributed in United Kingdom, EuropeanUnion, RSA, Israel and Japan in January 1995 by Locum International Publishing House(Houston, Israel, South Africa).
Second International Edition - 02.
Published and distributed in United Kingdom, United States, European Union, Israel, Asia andJapan in June 1998 by Locum International Publishing House (Houston, Israel, South Africa).
Third International Edition - 03. Published in March 2001 and distributed in United Kingdom,
United States, European Union, Israel, Asia and Japan by Locum International Publishing House(Houston, Israel, South Africa).
Copyright © 1995 -2001 Handbook of Pharmaceutical Generic Development
Text Copyright © 1994 - Handbook of Pharmaceutical Generic Development
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Locum International Publishing House PO Box 874, 50 Gilad Street Kochav Yair 44864 Israel.
All right reserved.
ISSN Series 0793 8772 - Part One
ISSN Series 0793 8780 - Part Two
GENERAL Drug Development Series ISSN 0793 7601
GENERAL Generic Series ISSN 0793 7407
GENERAL Generic e-Series ISSN 0793 7792 - Electronic Disc / CD ROM Version
GENERAL ISSN Drug Development e-Series 0793 761X - Electronic Disc Version

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Acknowledgments
I.A.G.I.M. (R&D) Foundation.

I.A.G.I.M. Members (1994 - 2001).
Contributions - Generic & Research Firms
Associate Universities, Technicons and Consultants.
Handbook Series Coordinating Committee.
International Journal of Drug Development.
Journal of Pharmaceutical Development.
International Journal of Generic Drugs.
I.A.G.I.M. Drug Development Archives
Locum International Archives.
FDA/OGD/CDER Maryland
Guides and Guidelines
Library of Congress.
AIC Conferences.
Editorial Board.
Pharm. Eur.
USP/NF.
USPC.
BP.
°

To Doribelle
for her years of support and help
to Sean for his expert knowledge on computerization
to David and Ari for running the project's computersand lastly to Pat for his inestimablecontribution.

Third International Edition.
2001

L O C U M

P U B L I S H I N G

H O U S E

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HANDBOOK OF GENERIC DRUG DEVELOPMENTDRUG DEVELOPMENT