Investigational New Drug Application
Mostrando 1-2 de 2 artigos, teses e dissertações.
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1. Non-clinical studies in the process of new drug development - Part II: Good laboratory practice, metabolism, pharmacokinetics, safety and dose translation to clinical studies
The process of drug development involves non-clinical and clinical studies. Non-clinical studies are conducted using different protocols including animal studies, which mostly follow the Good Laboratory Practice (GLP) regulations. During the early pre-clinical development process, also known as Go/No-Go decision, a drug candidate needs to pass through severa
Braz J Med Biol Res. Publicado em: 12/12/2016
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2. Historical and epidemiological reflections about the epidemiologic foundations of contemporary Clinical Medicine / Reflexão histórico-epistemológica sobre os fundamentos epidemiológicos da Clínica Médica contemporânea
Since 1960 Clinical Medicine suffered a kind of inflection in its internal mechanisms of producing theoretical knowledge, as well as in the way that this knowledge is applied in practical life. The most important difference in relation to the past was that problems of clinical nature like, differential diagnosis, therapeutical decisions, and prognosis estima
Publicado em: 2010