Biomedical subjects

J M Covey

Publications and source records attributed to J M Covey.

At least 19 recordsLinked to original sources

PubMed1994

Strategy and planning for chemopreventive drug development: clinical development plans. Chemoprevention Branch and Agent Development Committee. National Cancer Institute.

At the National Cancer Institute, Division of Cancer Prevention and Control, the Chemoprevention Branch and Agent Development Committee develop strategies for efficiently identifying, procuring, and advancing the most promising drugs into clinical trials. Scientific expertise is applied at each phase of development to critically review the testing methods and results, and to establish and apply criteria for evaluating the agents for further development. The Clinical Development Plan, prepared by the Chemoprevention Branch and the Agent Development Committee, is a summary of the status of the agent regarding evidence for safety and chemopreventive efficacy in preclinical and clinical studies. It also contains the strategy for further development of the drug that addresses pharmacodynamics, drug effect measurements, intermediate biomarkers for monitoring efficacy, toxicity, supply and formulation, regulatory approval, and proposed clinical trials. Sixteen Clinical Development Plans are presented here: N-acetyl-l-cysteine (NAC), aspirin, calcium, beta-carotene, 2-difluoromethylornithine (DFMO), DHEA analog 8354, 18 beta-glycyrrhetinic acid, N-(4-hydroxyphenyl)retinamide (4-HPR), ibuprofen, oltipraz, piroxicam, Proscar, sulindac, tamoxifen, vitamin D3 and analogs, and vitamin E. The objective of publishing these plans is to stimulate interest and thinking among the scientific community on the prospects for developing chemopreventive drugs.

Clinical Trials as Topic↗

PubMed1994

Liquid chromatographic analysis, stability and protein binding studies of the anti-HIV agent benzoic acid, 2-chloro-5[[(1-methylethoxy)thioxomethyl]amino]-,1-methylethyl ester.

A method was developed for the assay of benzoic acid, 2-chloro-5-[[(1-methylethoxyl)thioxomethyl]amino]-,1-meth yle thyl ester (NSC 629243) in hamster, mouse, human and, to a limited extent, dog plasma. Protein in 0.5 ml of plasma was precipitated with four volumes of methanol and the supernatant was analysed for NSC 629243 by LC. Liquid chromatography was carried out on a reversed-phase Nova-Pak C18 column, with a mobile phase of 60% acetonitrile in water at 1 ml min-1, and the compound was quantified with a UV detector set at 283 nm. Two standard curves of NSC 629243 were needed to cover a concentration range of 0.05-100 micrograms ml-1. All standard curves had correlation coefficients > 0.999. In practice, the minimum quantifiable concentration was approximately 0.05 microgram ml-1 in 0.5 ml of plasma. NSC 629243 appeared to have good stability at 37 degrees C in hamster, human and dog plasma at concentrations of 1 and 50 micrograms ml-1 (at least 80% remained in plasma after a 4 h incubation). Breakdown occurred in mouse plasma after 1 h at 37 degrees C, with extensive breakdown occurring after 24 h. NSC 629243 was extensively bound to plasma proteins of Syrian hamsters and humans. The extent of binding ranged from a minimum of 88.6% to a maximum of 99.9% over a concentration range of ca 1-100 micrograms ml-1.

Animals↗

PubMed1994