Drugs experiments

Figure 12.8 Drug experience/epidemiological sources available to the FDA (from the CDER Handbook).

Periodic Drug Experience Every 6 months for the first Distribution data... 

Ellis, H. (1961) Mescal A new artificial paradise. In The Drug Experience, edited by D. Ebin, pp. 225-236. Orion Press, New York. 

A case is a basic unit of drug safety surveillance. It is used to assure, to the greatest extent possible, the safety of approved drug products that are still in use. The basic unit of all postmarketing safety submissions is the adverse drug experience case , which is an individual adverse drug experience. 

The number on the outside of the case is required to be numeric or alphanumeric, not the name of the patient. Patient names are not permitted to be publicly disclosed in the context of a MedWatch report according to 21 CFR 21.63(f). The initial report is the first reported information received by the company about an individual s adverse drug experience. There must be a prompt attempt to obtain follow-up information about each initial report. The attempt(s) are made according to the company s written procedures. If the written safety procedures are not followed, the safety reports are not appropriately submitted, or the safety records are not appropriately kept, FDA has the authority under Section 80 of Part 315 to withdraw the market NDA. The follow-up report is the format for submitting additional information about an experience. Each case regards only one individual unless the experience is both temporally and clinically unrelated to a second event experienced by the same person taking the same drug product. 

Postmarketing adverse drug experiences are reported to a drug company by the public via regulatory authorities, literature, attorneys, consumers, and health... 

Postmarketing Surveillance Studies. Any surveillance of safety of a drug after marketing is postmarketing surveillance (PMS) (now often referred to as a postauthorization safety study). In practice the distinction between Phase TV studies and PMS is blurred (e.g., German drug experience studies). 

Keller, W.C., Bataller, N. and Oeller, D.S. (1998). Processing and evaluation of adverse drug experience reports at the Food and Drug Administration Center for Veterinary Medicine. 

Synonyms of adverse reactions generally include adverse medical effects, untoward effects, side effects, adverse drug experiences, and adverse drug reactions. Specific distinctions among some of these terms may be defined operationally. For example, the term adverse reaction is used to denote those signs and symptoms at least possibly related to a medicine, whereas the term adverse experience is used to include nonmedicine-related medical problems in a trial such as those emanating from trauma or concurrent illness. Distinctions among side effects, adverse events, and adverse reactions are illustrated in the definitions of the two former terms. 

Buchanan, J.F., and C.R. Brown. Designer drugs. A problem in clinical toxicology. Medical Toxicology and Adverse Drug Experience 3, 1988. 1-17. 

Adverse drug event (or adverse drug experience) (ADE)... 

Post-test write-up Each subject is encouraged to describe in as much detail as possible what he can recall of the drug experience and how he thinks he would have performed in combat under its influence. 

Zoloft works by making serotonin more available where it is needed. This may help to correct the chemical imbalance that can cause depression. If your brain gets the right amount of serotonin, depression might improve (my emphasis). To stick with drug experiments virtually requires the belief that your biology is bad ... 

Although 2-PAM is an FDA-approved drug, data submitted to the FDA to obtain approval are proprietary and were not released when requests for them were made to the FDA and to the manufacturer. A report of the FDA Adverse Drug Experiences Monitoring Program (October 30, 1983) contained one adverse reaction (hypotension following 1 g by intravenous Injection). 

Practice-orientated. Some drug experiments in healthy volunteers also serve a very practical purpose, namely to assess the effects of specific drugs on everyday activities, e.g. driving a car or operating complicated machinery. Such studies, which are easier to perform in a controlled fashion on healthy volunteers than on psychiatric patients, are based on the assumption that results from healthy subjects can be extrapolated to the conditions prevailing in patients, or at least to those who have recovered from their most severe symptoms and are still kept on medication. 

ASSESSMENT METHODS USED IN DRUG EXPERIMENTS ON HEALTHY VOLUNTEERS... 

Only a small proportion of the methods available, mainly for diagnostic purposes (Lezak, 1995, p. 385), have been used in drug experiments. Special mention should be made of the determination of criticalflicker fusion frequency (CFF) and of tachistoscopic trials, Le. of methods directed at the characteristics of visual perception. In contrast, drug effects on hearing have rarely, and those influencing senses of touch, smell and taste have hardly ever, been investigated (Turner, 1971). 

Executive functions can be sub-classified into volition, planning, purposive action and effective performance. Volition, this most subtle and central realm of human activity (Deutsch Lezak, 1995, p.651), is not usually assessed in drug experiments. Typical tests to assess planning are mazes of different complexity and brain teasers such as the Tower of London or Hanoi In drug experiments with healthy volunteers, purposive action and effective performance are usually measured by means of the methods listed in Tables 3.1 and 3.3. 

Spiegel, R., Dixon, K. Psychotropic drug experiments in normal subjects their relation to animal studies and clinical trials. In Spiegelstein, M.Y., Levy, A. (eds) Behavioral Models and the Analysis of Drug Action. Proc. 27th OHOLO Conf. Elsevier, Amsterdam, 1982, pp. 39-55. 

---