International Journal
of Generic Drugs
ISSN 0793-694X

International .Journal of :
Generic Drugs
Drug Development
Drug R&D
Drug Formulation
Generic Formula & Processess
Drug cGMP
Drug Process Validation
Generic Registration

Editorial
Journal TOC
Information
Call for Papers
Vol.1 1997
Vol.2 1998
Vol.3 1999
Vol.4 2000
Vol.5 2001
Vol.6 2002
Vol.7 2003
Vol.4 2000
Vol.5 2001
Vol.6 2002
Vol.7 2003/4
Vol.8 2005
Vol.9 2006
Vol.10 2007
Vol.11 2008
Vol.12 2009
Vol.13 2010
Vol.14 2011
Vol.15 2012
Editorial Board
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Editorial

International Journal of Generic Drugs

The International Journal of Generic Drugs publishes articles reviews and papers on all aspects of Generic and Innovative Drug Development from pre-formulation to aspects of regulatory strategy.

Emphasis is placed on the US exposure of the Generic Drug Industry with special reference to the on-time development of ANDA submissions.

The Chemistry, Manufacture and Controls (CMC) section of NDA development cover hands-on nuts-and-bolts developmental issues that vary across the full drug development spectrum from documentation requirements, excipients specifications, development (pre-to-final) formulation, scale-up, analytical, cleaning and process validation protocols necessary for the entire drug development process.

The overall objective in generic / CMC drug development is to get the newly developed product to the market place on time. The Journal attempts to clarify and simplify development and regulatory issues to achieve this crucial objective.

Articles include pre-formulation; drug development; granule sampling; bioequivalence data; specific container closure aspects, and manufacturing techniques; Quality Control; Quality Assurance; new curent developed analytical assay and impurity methodology; pharmaceutical stability in conjunction with regulatory requirements and complete model Abbreviated New Drug Applications.

Three differing geographic editions (US & Canada; Euro; Pacific Rim) are published highlighting various technological interests specific to the area.

The Journal publishes Drugs-Off-Patent Special Reports up to the year 2020 and holds updated lists and evaluation reports of Waxman/Gatt Patent / Exclusivity Extensions for the coming 10 years.

The Journal reviews issues that impact on all pivotal aspects of drug approval system with specific details for ANDA/AADAs NDAs and EU Dossiers and international perspectives of regulatory affairs. Features unique, authoritative side-by-side comparisons, summaries and development drug checklists as a Journal specialty.

The International Journal of Generic Drugs provides a free exchange of scientific knowledge while promoting the generic and innovative pharmaceutical sciences.

Selected papers, articles and reviews may be compiled by the publishers and incorporated after editing into the 24 volume authoritative Handbooks of Pharmaceutical Drug Development series with each volume, (updated once annually), targeting in full detail a specific dosage form.

Reviews and papers are refereed, while scientific correspondence is subject to editorial oversight. Contributions to this Journal are published free of charge. The Journal is printed on acid-free paper meeting ISO 9706, SFS 1083 and Nordic Environmental Standards of Certification.

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