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[Pharmacologic surveillance and safety evaluation of new drugs].
Acta Med Port. 1991 May-Jun; 4(3):141-6.AM

Abstract

Efficacy and safety evaluation are the main objectives of clinical trials. Through a rigorous scientific methodology they compare the efficacy of the new drugs with that of standard drugs or placebo. However the design of clinical trials in phase III is more centered in the study of efficacy than in its safety. Other reason, apart this, is a natural consequence of the low number of patients recruited for this phase when the incidence of most type B adverse drug reactions is usually of the order of 1:10(-4). Therefore it is the author's contention that post-marketing (phase IV) trials and surveillance should become commoner practices since they can contribute for a permanent evaluation of drugs safety after their approval and introduction in the market.

Authors+Show Affiliations

Cadeira de Medicina Legal e Toxicologia Forense, Faculdade de Medicina de Lisboa.

Pub Type(s)

English Abstract
Journal Article

Language

por

PubMed ID

1950664

Citation

Reys, L L.. "[Pharmacologic Surveillance and Safety Evaluation of New Drugs]." Acta Medica Portuguesa, vol. 4, no. 3, 1991, pp. 141-6.
Reys LL. [Pharmacologic surveillance and safety evaluation of new drugs]. Acta Med Port. 1991;4(3):141-6.
Reys, L. L. (1991). [Pharmacologic surveillance and safety evaluation of new drugs]. Acta Medica Portuguesa, 4(3), 141-6.
Reys LL. [Pharmacologic Surveillance and Safety Evaluation of New Drugs]. Acta Med Port. 1991 May-Jun;4(3):141-6. PubMed PMID: 1950664.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - [Pharmacologic surveillance and safety evaluation of new drugs]. A1 - Reys,L L, PY - 1991/5/1/pubmed PY - 1991/5/1/medline PY - 1991/5/1/entrez SP - 141 EP - 6 JF - Acta medica portuguesa JO - Acta Med Port VL - 4 IS - 3 N2 - Efficacy and safety evaluation are the main objectives of clinical trials. Through a rigorous scientific methodology they compare the efficacy of the new drugs with that of standard drugs or placebo. However the design of clinical trials in phase III is more centered in the study of efficacy than in its safety. Other reason, apart this, is a natural consequence of the low number of patients recruited for this phase when the incidence of most type B adverse drug reactions is usually of the order of 1:10(-4). Therefore it is the author's contention that post-marketing (phase IV) trials and surveillance should become commoner practices since they can contribute for a permanent evaluation of drugs safety after their approval and introduction in the market. SN - 0870-399X UR - https://www.unboundmedicine.com/medline/citation/1950664/[Pharmacologic_surveillance_and_safety_evaluation_of_new_drugs]_ L2 - http://www.actamedicaportuguesa.com/revista/index.php/amp/article/view/3341/2667 DB - PRIME DP - Unbound Medicine ER -