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Pharmacology / Medicine / Pharmaceuticals policy / Validity / Drug Master File / Validation / Excipient / Dosage form / Bioequivalence / Pharmaceutical industry / Pharmaceutical sciences / Clinical research


Quality Overall Summary - Chemical Entities (Applications for Drug Identification Number Submission) (QOS-CE (DINA))
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Document Date: 2013-07-12 14:26:08


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File Size: 37,69 KB

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Company

Drug Substance (Medicinal Ingredient) Company / BP / /

IndustryTerm

container closure systems / aqueous solution subsequent entry product / degradation products / aseptic processing / oral products / drug product / proposed validation protocol / manufacturing / manufacturing site / chemical name / manufacturing process / /

MedicalCondition

Bovine Spongiform Encephalopathy / Transmissible Spongiform Encephalopathy / /

Technology

Quality of Service / proposed validation protocol / Stability protocol / drug development / 8.2 Post-approval Stability Protocol / /

SocialTag