A Practical Approach to Risk-Benefit Estimation in Pediatric Drug Research

Author:

Koren Gideon

Publisher

Springer Science and Business Media LLC

Subject

Pharmacology (medical),Pediatrics, Perinatology, and Child Health

Reference16 articles.

1. US Department of Health and Human Services. Final Regulation Amending Basic HHS Policy for the Protection of Human Research Subjects. Federal Register 2009, 45 CFR 46 http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html .

2. Royal College of Paediatrics and Child Health. Ethics advisory committee guidelines for the ethical conduct of medical research involving children. Arch Dis Child. 2000;82:177–82.

3. Gupta D, Kishore K, Rastogi S, Singh PK, Agarwal A, Singh U. A comparative evaluation of local application of the combination of eutectic mixture of local anesthetics and capsaicin for attenuation of venipuncture pain. Anesth Analg. 2013;116(3):568–71.

4. Lambert G. Institutional responsibilities in pediatric ethics: the American Academy of Pediatrics new guidelines. Presented at “Ethics of Research at the Outset of Life”, Hospital for Sick Children, Toronto Jan 14–16, 1991.

5. Nicholson RH (editor). Medical research with children: ethics, law, and practice. Oxford: Oxford University Press; 1986.

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