Discussion on dose and dosage regimen exploring and confirming in new drug clinical trials

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Chinese Journal of Clinical Pharmacology and Therapeutics ›› 2008, Vol. 13 ›› Issue (8): 841-846.

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Discussion on dose and dosage regimen exploring and confirming in new drug clinical trials

YANG Jin-bo

Center for Drug Evaluation, State Food and Drug administration, Beijing 100038, China

Received:2008-06-23 Revised:2008-07-08 Online:2008-08-26 Published:2020-10-12

Abstract

Abstract: It is generally concerned by industries that some important questions in new drug clinical trials from designing the first dose in human to confirm the last dosage regimen, which is also one of the key bottlenecks to restrict the promotion of new drug research and development in China.Based on some references and review experience, this article is to discuss dose and dosage regimen exploring and confirming in new drug clinical trials.

Key words: new drug, dosage, explore, confirm

CLC Number:

R969

YANG Jin-bo. Discussion on dose and dosage regimen exploring and confirming in new drug clinical trials[J]. Chinese Journal of Clinical Pharmacology and Therapeutics, 2008, 13(8): 841-846.

[1]	FDA.Estimating the maximum safe starting dose in initial clinical trials for therapeutics in adult healthy volunteers [S].http:www.fda.gov cder guidance, 2005-07-21.
[2]	EMEA.Guideline on requirements for first-in-man clinical trials for potential high-risk medicinal products[S].http:www.emea.europa.eu, 2007-5-23.
[3]	ICH.Dose-response information to support drug registration E4[S].1994-3-10.
[4]	FDA.Development and use of risk minimization action plans[S].http: www.fda.gov cder guidance, 2005-3-24.

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Discussion on dose and dosage regimen exploring and confirming in new drug clinical trials

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