The Federal Food, Drug, and Cosmetic Act prohibits the shipment of a new drug into interstate commerce unless there exists an approved NDA or an effective IND application for that drug. In the European Union countries and countries that follow the EU Directives, the equivalent information that ...
IMPDIndianapolis Metropolitan Police Department(Indianapolis, Indiana) IMPDInvestigational Medicinal Product Dossier IMPDInosine Monophosphate Dehydrogenase IMPDInstitute for Multi-Party Democracy IMPDInstitute of Malaria and Parasitic Diseases(Kabul, Afghanistan) ...
- Congress of the European-association-of-nuclear-medicine 被引量: 0发表: 2013年 The Investigational Medicinal Product Dossier (IMPD): EU's CTA vs. FDA's IND Radiopharmaceuticals are the core of nuclear medicine. This is a statement that no one would or could refute. In fact, during the ...
WhitepaperBiologic drug products: A 5-point strategy for building a robust CMC dossier Getting biological drug products to first-in-human (FIH) trials requires a deep and nuanced understanding of the scientific and regulatory challenges unique to these complex large molecule substances. Prioritizing re...
Certificates of suitability to the monographs of the European Pharmacopoeia (CEP) Active Substance Master Files (ASMF) US: Preparation and review of CMC-data for Investigational New Drug Applications (IND) Common Technical Document (CTD): Module 2.3 (Quality Overall Summary) and Module 3 (Qual...
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