Decision points in drug development

Clinical Trials of Drugs and Biopharmaceuticals

Volumn , Issue , 2005, Pages 77-85

  Lee, Lucia H ^a   Wu, Christopher L ^b   Lee, Benjamin R ^c,d   Lee, Chi Jen ^a  

^a CENTER FOR BIOLOGICS EVALUATION AND RESEARCH   (United States)

^b JOHNS HOPKINS UNIVERSITY SCHOOL OF MEDICINE   (United States)

^c LONG ISLAND JEWISH MEDICAL CENTER   (United States)

^d ALBERT EINSTEIN COLLEGE OF MEDICINE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

EID: 84937558305     PISSN: None     EISSN: None     Source Type: Book    
DOI: None     Document Type: Chapter

References (7)

1. Griffin, J.P., O'Grady, J., and D'Arcy, P.F., The Textbook of Pharmaceutical Medicine, 3rd ed., The Queens University of Belfast, U.K., 1998.
2. Drews, J., In Quest of Tomorrow.s Medicines, Springer-Verlag, New York, 1998.
3. Graham, M.A. and Kaye, S.B., New approaches in preclinical and clinical pharmacokinetics, Pharma-cokin. Cancer Chemother., 17, 27, 1993.
4. Bolton, S., Design and conduct of clinical trials, in Remington: The Science and Practice of Pharmacy, 20th ed., Gennaro, A.R., Ed., Lippincott Williams & Wilkins, Baltimore, MD, 2000, pp. 130-131.
5. FDA, Guideline on Studies in Support of Special Populations: Geriatrics, U.S. Food and Drug Administration, Washington, D.C., 1994.
6. Colburn, W.A., Gibson, D.M., Wiens, R.E. et al., Food increases the bioavailability of isotretinoin, J. Clin. Pharmacol., 23, 534-539, 1983.
7. ICH, Efficacy Tripartite Guideline on Dose Response Information To Support Drug Registration, International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, Geneva, Switzerland, 1993.