International .Journal of :
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International Journal of Generic
International Journal of Generic Drugs
Editor in Chief:
Prof. Dr. Jeremy David Block
B.Sc.(Eng.) M.Sc. D.Pharm. (Wits) N.I.E (Wits)
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 CTD / eCTD / ANDA
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 / CTD 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 current 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 e-CTD/CTD/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
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. Locum R&D concentrates on all 81 neuro-degenerative
diseases (from Stickmans to M/S) with a very special emphasis on the
epidemiology, etiology and epigenetics of Mulltiple Sclerosis.
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.