Regulatory science as a bridge between science and society

Clinical Pharmacology and Therapeutics

Volumn 90, Issue 1, 2011, Pages 29-31

  Tominaga, T ^a   Asahina, Y ^a   Uyama, Y ^a   Kondo, T ^a  

^a PHARMACEUTICALS AND MEDICAL DEVICES AGENCY   (Japan)

Author keywords

[No Author keywords available]

Indexed keywords

OSELTAMIVIR; ROSIGLITAZONE; THALIDOMIDE;

BEHAVIOR DISORDER; DATA ANALYSIS; DECISION MAKING; DRUG APPROVAL; DRUG DEVELOPMENT; DRUG EFFICACY; DRUG QUALITY; DRUG RESEARCH; DRUG SAFETY; DRUG SURVEILLANCE PROGRAM; FOOD AND DRUG ADMINISTRATION; HEALTH CARE ORGANIZATION; HUMAN; NONHUMAN; PRIORITY JOURNAL; REGULATORY SCIENCE; REVIEW; RISK ASSESSMENT; RISK BENEFIT ANALYSIS;

DATA INTERPRETATION, STATISTICAL; DATABASES, FACTUAL; DECISION MAKING; DRUG APPROVAL; DRUG INDUSTRY; EUROPE; GOVERNMENT AGENCIES; HUMANS; PHARMACOLOGY, CLINICAL; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 79959409355     PISSN: 00099236     EISSN: 15326535     Source Type: Journal    
DOI: 10.1038/clpt.2011.89     Document Type: Review

References (11)

1. US Food and Drug Administration. Advancing Regulatory Science for Public Health (October 2010).
2. European Medicines Agency. Regulatory Science .
3. Uchiyama, M. Regulatory science. PDA J. Pharm. Sci. Technol. 49, 185-187 (1995).
4. Somers, G.S. Thalidomide and congenital abnormalities. Lancet 1, 912-913 (1962).
5. International Conference on Harmonisation. Ethnic Factors in the Acceptability of Foreign Clinical Data: E5 (R1) (11 March 1998).
6. Ichimaru, K., Toyoshima, S. & Uyama, Y. Effective global drug development strategy for obtaining regulatory approval in Japan in the context of ethnicity-related drug response factors. Clin. Pharmacol. Ther. 87, 362-366 (2010).
7. Pharmaceuticals and Medical Devices Agency, Japan. China/Japan/Korea Tripartite Cooperation (2010).
8. Blind, E., Dunder, K., de Graeff, P.A. & Abadie, E. Rosiglitazone: a European regulatory perspective. Diabetologia 54, 213-218 (2011).
9. Woodcock, J., Sharfstein, J.M. & Hamburg, M. Regulatory action on rosiglitazone by the U.S. Food and Drug Administration. N. Engl. J. Med. 363, 1489-1491 (2010).
10. Pharmaceuticals and Medical Devices Agency, Japan. Points to Be Considered by the Review Staff Involved in the Evaluation Process of New Drug (17 April 2008).
11. European Medicines Agency. Benefit-risk methodology project work package 2 report: applicability of current tools and processes for regulatory benefit-risk assessment (31 August 2010).