Considerations regarding the use of nonhuman primates in assessing safety endpoints for pharmaceuticals.

Brown, Paul C; Wange, Ronald L

Brown, Paul C; Wange, Ronald L.

Afiliação

Brown PC; US Food and Drug Administration, Center for Drug Evaluation and Research, Silver Spring, MD, USA.
Wange RL; US Food and Drug Administration, Center for Drug Evaluation and Research, Silver Spring, MD, USA. Electronic address: Ronald.Wange@fda.hhs.gov.

Regul Toxicol Pharmacol ; 143: 105449, 2023 Sep.

Article em En | MEDLINE | ID: mdl-37453554

Assuntos

COVID-19; Pandemias; Animais; Humanos; Testes de Toxicidade; Primatas; Preparações Farmacêuticas

Palavras-chave

3Rs; Animal studies; CDER; COVID-19; FDA; Nonhuman primate; Pharmaceutical regulation; Toxicity testing

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Texto completo: 1 Base de dados: MEDLINE Assunto principal: Pandemias / COVID-19 Tipo de estudo: Guideline Limite: Animals / Humans Idioma: En Revista: Regul Toxicol Pharmacol Ano de publicação: 2023 Tipo de documento: Article País de afiliação: Estados Unidos

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