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Strategy and planning for chemopreventive drug development: Clinical development plans II
Author(s) -
Kelloff Gary J.,
Crowell James A.,
Hawk Ernest T.,
Steele Ver E.,
Lubet Ronald A.,
Boone Charles W.,
Covey Joseph M.,
Doody Linda A.,
Omenn Gilbert S.,
Greenwald Peter,
Hong Waun K.,
Parkinson David R.,
Bagheri Donya,
Baxter Gregory T.,
Blunden Margaret,
Doeltz Mary K.,
Eisenhauer Karen M.,
Johnson Karen,
Knapp Gene G.,
Longfellow David G.,
Malone Winfred F.,
Nayfield Susan G.,
Seifried Harold E.,
Swall Leah M.,
Sigman Caroline C.
Publication year - 1996
Publication title -
journal of cellular biochemistry
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.028
H-Index - 165
eISSN - 1097-4644
pISSN - 0730-2312
DOI - 10.1002/jcb.240630705
Subject(s) - drug development , pharmacology , clinical trial , curcumin , medicine , celecoxib , retinoic acid , drug , chemistry , biochemistry , gene
This is the second publication of Clinical Development Plans from the National Cancer Institute, Division of Cancer Prevention and Control, Chemoprevention Branch and Agent Development Committee. The Clinical Development Plans summarize the status of promising chemopreventive agents regarding evidence for safety and chemopreventive efficacy in preclinical and clinical studies. They also contain the strategy for further development of these drugs, addressing pharmacodynamics, drug effect measurements, intermediate biomarkers for monitoring efficacy, toxicity, supply and formulation, regulatory approval, and proposed clinical trials. Sixteen new Clinical Development Plans are presented here: curcumin, dehydroepiandrosterone, folic acid, genistein, indole‐3‐carbinol, perillyl alcohol, phenethyl isothiocyanate, 9‐ cis ‐retinoic acid, 13‐ cis ‐retinoic acid, l ‐selenomethionine and 1,4‐phenylenebis(methylene)selenocyanate, sulindac sulfone, tea, ursodiol, vitamin A, and (+)‐vorozole. The objective of publishing these plans is to stimulate interest and thinking among the scientific community on the prospects for developing these and future generations of chemopreventive drugs. © 1997 Wiley‐Liss, Inc.