Recent trends and success factors in reducing the lag time to approval of new drugs in Japan

Clinical Pharmacology and Therapeutics

Volumn 95, Issue 5, 2014, Pages 467-469

  Honig, P K ^a  

^a NONE

Author keywords

[No Author keywords available]

Indexed keywords

ANTINEOPLASTIC AGENT; IMMUNOMODULATING AGENT; NEUROLOGICAL AGENT; NEW DRUG; UNCLASSIFIED DRUG;

CLINICAL TRIAL (TOPIC); DOSE CALCULATION; DRUG APPROVAL; DRUG EFFICACY; DRUG INDUSTRY; EUROPEAN UNION; HUMAN; JAPAN; PRIORITY JOURNAL; REGISTRATION; REVIEW; UNITED STATES;

CLINICAL TRIALS AS TOPIC; DRUG APPROVAL; DRUG INDUSTRY; EUROPE; HUMANS; JAPAN; TIME FACTORS; UNITED STATES;

EID: 84898999359     PISSN: 00099236     EISSN: 15326535     Source Type: Journal    
DOI: 10.1038/clpt.2013.256     Document Type: Review

References (8)

1. Molzon, J.A. et al. The value and benefits of the International Conference on Harmonisation to drug regulatory authorities: advancing harmonization for better public health. Clin. Pharmacol. Ther. 89, 503-512 (2011).
2. International Conference on Harmonisation. Ethnic factors in the acceptability of foreign clinical trial data: ICH E5(R1) 〈http://www.ich. org/products/guidelines/efficacy/article/efficacy-guidelines.html〉.
3. Arnold, F.L., Fukunaga, S., Kusama, M., Matsuki, N. & Ono, S. Assessment of factors associated with dose differences between Japan and the United States. Clin. Pharmacol. Ther. 95, 542-549 (2014).
4. Huang, S.M. & Temple, R. Is this the drug or dose for you? Impact and consideration of ethnic factors in global drug development, regulatory review, and clinical practice. Clin. Pharmacol. Ther. 84, 287-294 (2008).
5. Malinowski, H.J., Westelinck, A., Sato, J. & Ong, T. Same drug, different dosing: differences in dosing for drugs approved in the United States, Europe and Japan. J. Clin. Pharmacol. 48, 900-908 (2008). (Pubitemid 352009498)
6. Ueno, T., Asahina. Y., Tanaka, A., Yamada, H., Nakamura, M. & Uyama Y. Significant differences in drug lag in clinical development among various strategies used for regulatory submissions in Japan. Clin. Pharmacol. Ther. 95, 533-541 (2014).
7. Honig, P. & Lalonde, R. The economics of drug development: a grim reality and a role for clinical pharmacology. Clin. Pharmacol. Ther. 87, 247-251 (2010).
8. Uyama, Y. New trend of clinical development in Japan; from sequential bridging to simultaneous global development. FIP SIG Regulatory Science Workshop, Taipei, Taiwan, 27-28 November 2013 〈http://www.pmda.go.jp/ regulatory/file/english-presentation/new-drug/M-B-48uyama. pdf〉.