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Semin Oncol ; 19(6): 613-21, 1992 Dec.
Artículo en Inglés | MEDLINE | ID: mdl-1462163


The discovery and development of new anticancer drugs is a complex and largely empirical process. New compounds can be discovered by screening, modification of existing compounds, rational drug design, and serendipitous basic research observations. Selection of compounds for clinical trials depends on assays of uncertain predictive value. In the pharmaceutical industry, priorities for development of potentially active entities are set and available resources allocated based on the availability and cost of supplies, patent status, potential spectrum of activity, ability to meet regulatory requirements, and market assessments. Competition for resources also occurs from noncancer drugs, eg, cardiovascular agents. Clinical development (testing and approval for commercial distribution) requires close attention to the requirements of national regulatory agencies such as the United States Food and Drug Administration. The arbitrary nature by which compounds with antitumor potential are chosen for development means that some that would be useful never reach clinical trial and others are never made generally available. This article reviews the decision making process in the pharmaceutical industry by which compounds are identified and selected for clinical trial, the regulations in the United States that govern such trials, and what is required to have the drug approved for commercial distribution.

Industria Farmacéutica , Drogas en Investigación , Animales , Antineoplásicos , Ensayos Clínicos como Asunto , Aprobación de Drogas , Evaluación Preclínica de Medicamentos , Humanos , Estados Unidos
Radiother Oncol ; 12(4): 301-13, 1988 Aug.
Artículo en Inglés | MEDLINE | ID: mdl-3055073


The development of new anticancer agents is a long-term process, which involves the acquisition of new compounds, screening for antitumor activity, production and formulation, animal toxicology and finally, evaluation of toxicity and antitumor activity of the compound in man (Table I). In this paper, the main steps in the early development of new cytotoxic agents up to phase II clinical studies will be discussed. However, clinical phase III-IV trails, where the efficacy of the drug has been proven, should be dealt with separately.

Antineoplásicos , Animales , Evaluación de Medicamentos/métodos , Evaluación Preclínica de Medicamentos/métodos , Humanos
In Vivo ; 1(1): 1-13, 1987.
Artículo en Inglés | MEDLINE | ID: mdl-2979758


In an attempt to increase the predictability of preclinical antitumor testing, the value of human tumor lines in immune-deficient nude mice is assessed by reviewing the relevant literature. This test model is rather elaborate due to the nature of the animal as well as test and evaluation procedure. However, it represents a realistic simulation of clinical drug treatment. This is demonstrated by (a) a good correlation of drug effects in the nude mouse with clinical results in the donating patient's tumor and (b) by a good predictability of a panel of human tumor lines for clinically effective drugs. In order to avoid clinical trials with inactive drugs and no therapeutic benefit for a large number of patients, the application of human tumor xenografts in anticancer drug development is warranted.

Antineoplásicos/uso terapéutico , Neoplasias/tratamiento farmacológico , Trasplante Heterólogo , Animales , Evaluación Preclínica de Medicamentos/métodos , Humanos , Ratones , Ratones Desnudos , Trasplante de Neoplasias , Neoplasias/patología