共 18 条
- [1] Regulatory and Scientific Aspects of Drug-Drug Interaction Studies [J]. CLINICAL PHARMACOLOGY IN DRUG DEVELOPMENT, 2012, 1 (02): : 43 - +
- [4] The electronic common technical document - Transition to a new paradigm in regulatory submissions [J]. BIOPHARM INTERNATIONAL-THE APPLIED TECHNOLOGIES OF BIOPHARMACEUTICAL DEVELOPMENT, 2003, : 24 - 27
- [6] The Common Technical Document: the changing face of the New Drug Application [J]. Nature Reviews Drug Discovery, 2003, 2 : 71 - 74
- [7] From Cell to Product/Technical and regulatory aspects of the biotechnological production of monoclonal antibodies [J]. PHARMAZEUTISCHE INDUSTRIE, 2013, 75 (02): : 334 - 339
- [8] Drug use in horses and identification document - Regulatory aspects since July 2000 [J]. TIERARZTLICHE PRAXIS AUSGABE GROBTIERE NUTZTIERE, 2001, 29 (02): : 57 - 60
- [9] 3D DOCUMENT - THE NEW TYPE OF THE SCIENTIFIC AND TECHNICAL DOCUMENTATION [J]. HERALD OF AN ARCHIVIST, 2013, (02): : 192 - 203
- [10] Scientific and Regulatory Considerations in Solid Oral Modified Release Drug Product Development [J]. AAPS JOURNAL, 2016, 18 (06): : 1406 - 1417