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International Journal
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Information International Journal of Generic Drugs Keep informed of the important regulations FDA will adopt this year so you can plan your drug development and manufacturing operations ahead. Learn what the FDA inspectors expect you to do to get new drug product approved quickly. Keep on top of all trends related to the chemistry, manufacturing and controls in the drug development and manufacturing areas. Stay current on PAI know-how, new regulations FDA is adopting this year and important changes to GMP regulations affecting your drug development and pivotal manufacture. Model cleaning validation, process validation and analytical validation protocols and plans that have passed successful PAI reviews. The Journal will save your sales division tens of thousands on lost sales in the first year of marketing. The Journal will speedup approval faster and reduce agency times by eradicating universal ANDA and NDA-CMC pitfalls. The Journal dissects and analyzes common and unusual drug development and file submission faults and tell you how these hazards can be avoided to achieve a speedier and less expensive approval. Subscribe to the Journal and we guarantee it will help you complete drug development faster, cheaper and almost error-free with the FDAs blessing. Electronic Journal on CD The Electronic International Journal of Generic Drugs is available on CD ROM Portable Document Format (PDF). The Electronic Journal on CD may be ordered direct via the Internet, or e-mail (ISSN 0793-7415) Electronic Journal via E-mail The Electronic International Journal of Generic Drugs is transmitted in full color via the Internet direct to the subscribers e-mail address. This popular format is gives exceptional value for money as an invaluable day-to-day drug development tool. Complimentary e-mail issues are transmitted to over 75 International Agency Regulators and Government Departments. (ISSN 0793-7415) The International Journal of Generic Drugs Designed for pharmaceutical researchers in the NDA CMC (chemistry manufacture control) and Generic Drug Development sectors including detailed aspects of ANDA (pivotal) and commercial validation batch manufacture. Regulatory know-how Key know-how on ODGs expectations of the pivotal batch manufacture highlighting side-by-side batch comparisons between pivotal regulatory batch and commercial validation batches. Full coverage - The International Journal Series A comprehensive forum of eight pharmaceutical know-how journals filled with essential drug development data associated with CMC profiles, generic drug development, manufacture, cGMP, process validation, quality assurance and control. Each issue targets specific dosage forms detailing from pre-formulation, developmental to scale-up and process validation topics. Journal issues contains material dedicated to the review of specific dosage forms and specific development know-how and manufacturing topics. This Journal features drug development articles, technical reviews, procedural checklists, SOPs and side-by-side specification comparisons of all major dosage form parameters ranging from A (actives) to V (validation). A primary source Journal to fill the ever changing information gap for CMC and Generic Drug Development. The Journal emphasizes a multidisciplinary approach between all key development and production departments. |
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