Author:
Van Buskirk Glenn A.,Asotra Satish,Balducci Christopher,Basu Prabir,DiDonato Gerald,Dorantes Angelica,Eickhoff W. Mark,Ghosh Tapash,González Mario A.,Henry Theresa,Howard Matthew,Kamm Jason,Laurenz Steven,MacKenzie Ryan,Mannion Richard,Noonan Patrick K.,Ocheltree Terrance,Pai Umesh,Poska Richard P.,Putnam Michael L.,Raghavan Ramani R.,Ruegger Colleen,Sánchez Eric,Shah Vinod P.,Shao Zezhi Jesse,Somma Russell,Tammara Vijay,Thombre Avinash G.,Thompson Bruce,Timko Robert J.,Upadrashta Satyam,Vaithiyalingam Sivakumar
Publisher
Springer Science and Business Media LLC
Subject
Drug Discovery,Pharmaceutical Science,Agronomy and Crop Science,Ecology,Aquatic Science,General Medicine,Ecology, Evolution, Behavior and Systematics
Reference37 articles.
1. Skelly JP, Van Buskirk GA, Savello DR, Amidon GL, Arbit HM, Dighe S, et al. Scaleup of immediate release oral solid dosage forms. Pharm Res. 1993;10:313–6.
2. Skelly JP, Van Buskirk GA, Arbit HM, Amidon GL, Augsburger L, Barr WH, et al. Scaleup of oral extended-release dosage forms. Pharm Res. 1993;10(12):1800–5.
3. Communication from the Commission—Guideline on the details of the various categories of variations to the terms of marketing authorizations for medicinal products for human use and veterinary medicinal products. Off J Eur Union, 22.1.2010, C17/1-41. http://ec.europa.eu/health/files/eudralex/vol-2/c17_1/c17_1_en.pdf .
4. Post-Notice of Compliance (NOC) Changes—quality guidance appendix 1 for human pharmaceuticals. Canada Ministry of Health, Health Products and Food Branch, Implementation 10/17/2011. http://www.hc-sc.gc.ca/dhp-mps/alt_formats/hpfb-dgpsa/pdf/prodpharma/applic-demande/guide-ld/postnoc_change_apresac/noc_pn_quality_ac_sa_qualite-eng.pdf .
5. FDA challenges and opportunities report—innovation or stagnation: challenge and opportunity on the critical path to new medical products. US Department of Health and Human Services, Food and Drug Administration, March 2004. http://www.fda.gov/ScienceResearch/SpecialTopics/CriticalPathInitiative/CriticalPathOpportunitiesReports/ucm077262.htm .
Cited by
32 articles.
订阅此论文施引文献
订阅此论文施引文献，注册后可以免费订阅5篇论文的施引文献，订阅后可以查看论文全部施引文献