International
Journal of Drug Development Int .J. of Generic
Drugs
The Int. Journal Series
|
Editorial
The International Journal of Drug Development publishes articles and reviews on all aspects of Pharmaceutical Drug Development from pre-formulation to aspects of regulatory strategy. Emphasis is placed on US and EC exposure to the Drug Development Industry with special reference to the on-time development of EU Dossiers, NDA & 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 Innovative CMC / generic 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. Papers include pre-formulation of drug development,
key biostudies bioequivalence know-how specific container closure aspects, and
manufacturing techniques, Quality Control, Quality Assurance, and pharmaceutical
stability in conjunction with regulatory requirements The Journal publishes Drugs-Off-Patent Special Reports up to the year
2017 and holds updated lists and evaluation reports of every
Waxman and Gatt Patent / Exclusivity Extension for the coming
17 years. Reviews issues that impact on all aspects of drug approval
system with specific details for NDAs / ANDA / AADAs OTCs and EU Dossiers
and international perspectives of regulatory affairs. Features authoritative
side-by-side comparisons, summaries and development drug checklists. The International Journal of Drug Development provides a free exchange
of scientific knowledge while promoting the innovative, generic and OTC pharmaceutical
sciences. Selected papers, articles and reviews may be compiled by the publishers
and incorporated after editing into Handbooks of Pharmaceutical Drug Development
on specific drug dosage forms. A free monthly e-mail subscription to the popular Drug Development Letter is obtainable to pharmaceutical and drug development personnel on request to:- contact |
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