PRODUCT DEVELOPMENT GUIDE P RE …

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international journal of Generic Drugs international journal 312of Generic Drugs e-* 0793 694X US/Canada ISSN 0793 7784 EuroISSN 0793 7822 Pacific RimPRODUCT DEVELOPMENT GUIDEPRE-FORMULATION - SOFT GELATIN CAPSULESIntroductionGuidelines for the DEVELOPMENT of a ANDA PRODUCT for the US market, Note: sometests or procedures may be unnecessary. The order of performing the variousstages may change depending on the PRODUCT under DEVELOPMENT . Theseguidelines may be modified for other geographic StageScope of PRODUCT DEVELOPMENT Stage 1Literature SearchLiterature ResearchUSP BP Pharm. Eur, PDR, Martindale, Merck, Florey, Vidal,Text and journalsFDA - FOISummary Basis of Approval - On request form FDAOn-linecomputerizedsearchFDA CDERElectronic Data Base (articles and publication on testmethods, Dissolution synthesis procedures, drug impurities,pharmacokinetics and dynamics)Evaluation of Biostudy parameters, Dissolution evaluationOrange GUIDE + FDA CDER WWW Patent Consultant Stage 2 Active SourcingSourcing for ActiveRaw MaterialInternational Suppliers US, European, Asian, (ACIC-Canada) (AllChem-UK) (Lek-Czech), (Esteves; Moehs;Uquifa-Spain); (Biopharma, , Midy-Italy) (Chemcaps,Reddy; Tricon-India); (Federa-Brussels) - Review suppl

International Journal of Generic Drugs http://www.locumusa.com International Journal 314 of Generic Drugs e-* info@locumEURO.com ISSN 0793 694X US/Canada ISSN 0793 7784 Euro ISSN 0793 7822 Pacific Rim

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