Current status and issues of drug development strategy in japan

Drug Delivery System

Volumn 22, Issue 1, 2007, Pages 65-72

  Saito, Hironobu ^a   Fujieda, Toru ^a   Naganuma, Hideo ^a  

^a DAIICHI SANKYO CO   (Japan)

Author keywords

CRC; drug development; ICH; infrastructure; micro dosing

Indexed keywords

EID: 77956064545     PISSN: 09135006     EISSN: 18812732     Source Type: Journal    
DOI: 10.2745/dds.22.65     Document Type: Article

References (5)

1. Innovation or Stagnation, Challenge and Opportunity on the Critical Path to New Medical Products. FDA, March 2004.
2. Guidance for Industry, Investigators, and Reviewers Exploratory IND Studies. FDA, January 2006.
3. Position paper on non-clinical safety studies to support clinical trials with a single microdose. European Medicines Agency, June 2004.
4. Watanabe I, Koga T et al.: A study to survey susceptible genetic factors responsible for troglitazone-associated hepatotoxicity in Japanese patients with type 2 diabetes mellitus. Clin Pharmacol Ther 73(5): 435-455, 2003.
5. Bauer P, Einfalt J:Application of adaptive designs - A review. Biometrical Journal 48: 493-506, 2006.