Assessing risk/benefit for trials using preclinical evidence: a proposal-Reference-Cited by-同舟云学术

Assessing risk/benefit for trials using preclinical evidence: a proposal

Published:2015-10-13 Issue:1 Volume:42 Page:50-53
ISSN:0306-6800
Container-title:Journal of Medical Ethics
language:en
Short-container-title:J Med Ethics

Author:

Kimmelman Jonathan,Henderson Valerie

Publisher

BMJ

Subject

Health Policy,Arts and Humanities (miscellaneous),Issues, ethics and legal aspects,Health(social science)

Reference20 articles.

1. Declaration of Helsinki;World Medical Association;JAMA,2013

2. Should preclinical studies be registered?;Kimmelman;Nat Biotechnol,2012

3. Guidance for Industry: Content and Format of Investigational New Drug Applications (INDs) for Phase 1 Studies of Drugs, Including Well-Characterized, Therapeutic, Biotechnology-derived Products. In: Services USDoH, ed., 1995.

4. Guidance for Industry: Preclinical Assessment of Investigational Cellular and Gene Therapy Products. In: Services USDoHH, ed., 2013.

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