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International Journal
of Drug Development

Int .J. of Generic Drugs
Int .J. of Drug Development

Int .J. of Drug R&D
Int .J. of Drug Formulation

Int .J. of GenericFormula & Processes
Int .J. of Drug cGMP
Int .J. of Drug Process Validation

Int .J. of Generic Registration


Editorial
Information
Vol.1 Index 1996
Vol.2 Index 1997
Vol.3 Index 1998
Vol.4 Index 1999
Vol.5 Index 2000
Vol.6 Index 2001
Vol.7 Index 2002
Vol.8 Index 2003
Editorial Board
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Editorial
International Journal of Drug Development

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.

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.

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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