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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
Editorial Board
Free Journal
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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 2017 and holds updated
lists and evaluation reports of Waxman/Gatt Patent / Exclusivity Extensions
for the coming 17 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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