Regulations and guidance documents published by the fda concerning women rsquo s participation in industry sponsored clinical trials have changed significantly over the past half century 17 after the tragedies caused by the use of thalidomide in pregnant women the fda issued ldquo general considerations for the clinical evaluation of drugs rdquo in 1977.

In malaysia similar guidelines were formulated in the wake of greater demand by the pharmaceutical industry to conduct clinical trials in the country the malaysian guidelines for gcp was first published in october 1999 and the second edition was released in january 2004.

The considerations investigators must take into account when designing clinical trials include patient population previous therapies assessment of the central nervous system end points and leptomeningeal disease according to the new guidelines new guidance from the fda informs clinical trial.

Phase 2 and 3 clinical trials that require fda ind or ide application this protocol template aims to facilitate the development of two types of clinical trials involving human participants the first type of trials are phase 2 and 3 clinical trial protocols that require a food and drug administration fda investigational new drug ind or.

Pre clinical trials tests screening tests tests on isolated organs tests on bacterial culture tests on animal models of human diseases 11 importance of pre clinical trials bull triparanol is a drug that lowers the concentration of cholesterol in plasma bull it was marketed in the usa in 1959.