Clinical drug research

Cohen A, Posner J, eds. A Guide to Clinical Drug Research, 2nd ed., Kluwer Academic Publishers, The Netherlands, 2000. 

No attempt will be made to list the major drug interactions. These are readily available in a large number of texts devoted to the subject. The general principles and typical samples of various types of drug interactions, however, which may be of interest in clinical drug research, are discussed below. 

Creativity is a quality that cannot be developed through formal training. Creativity requires bold conjecture and it expresses itself in newer, better ways to accomplish the same goals. An example of creativity in clinical drug research might involve the development of a variable... 

Preparation of materials to be distributed directly to health care professionals, employees, and patients. Setting up and managing clinical drug research and the information derived from it. 

American Society of Health-System Pharmacists. ASHP guidelines on clinical drug research. Am. J. Health-Syst. Pharm. 1998, 55. 369-376. 

More recently, the bottleneck of drug research has shifted from hit-and-lead discovery to lead optimization, and more specifically to PK lead optimization. Some major reasons are (i) the imperative to reduce as much as feasible the extremely costly rate of attrition prevailing in preclinical and clinical phases, and (ii) more stringent concerns for safety. The testing of ADME properties is now done much earlier, i.e. before a decision is taken to evaluate a compound in the clinic. 

Scatter plots are used widely in clinical trial research, as they are intuitive to read and have many applications. We often look for a drug s effect on some parameter (Y axis) over time (X axis). Also, change-from-baseline scatter plots are useful when you plot the baseline on the X axis and the follow-up value on the Y axis. You will see an example of this graph later in this chapter. 

Despite the plethora of new drug developments in neuroscience, most clinical drug trials are conducted in predominantly Caucasian populations even though they are used frequently in non-Caucasian populations. There is an urgent need to clarify the appropriateness of extrapolating research data of clinical drug trials... 

Kaminer, Y., Bukstein, O., Tarter, R. (1989). Teen Addiction Severity Index (T-ASI) Clinical and research implications A preliminary report. National Institute on Drug Abuse Research Monograph, 95, 363. 

Clinical drug trials represent research with human subjects (Cato, 1988). All research involving human subjects that is supported by the federal government or... 

Nichol, F.R., Contract clinical research value to in-house drug development, in Clinical Drug Trials and Tribulations, Cato, A., Sutton, L., and Cato 111, A., Eds., Marcel Dekker, New York, 2002, chap. 21. 

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