Scientific and Regulatory Policy Committee Points to Consider Review: Inclusion of Reproductive and Pathology End Points for Assessment of Reproductive and Developmental Toxicity in Pharmaceutical Drug Development.

Halpern, Wendy G; Ameri, Mehrdad; Bowman, Christopher J; Elwell, Michael R; Mirsky, Michael L; Oliver, Julian; Regan, Karen S; Remick, Amera K; Sutherland, Vicki L; Thompson, Kary E; Tremblay, Claudine; Yoshida, Midori; Tomlinson, Lindsay

Halpern, Wendy G; Ameri, Mehrdad; Bowman, Christopher J; Elwell, Michael R; Mirsky, Michael L; Oliver, Julian; Regan, Karen S; Remick, Amera K; Sutherland, Vicki L; Thompson, Kary E; Tremblay, Claudine; Yoshida, Midori; Tomlinson, Lindsay.

Afiliação

Halpern WG; Genetech, South San Francisco, California, USA halpern.wendy@gene.com.
Ameri M; GlaxoSmithKline, King of Prussia, Pennsylvania, USA.
Bowman CJ; Pfizer, Groton, Connecticut, USA.
Elwell MR; Covance, Chantilly, Virginia, USA.
Mirsky ML; Pfizer, Groton, Connecticut, USA.
Oliver J; Incyte, Wilmington, Delaware, USA.
Regan KS; Regan Path/Tox Services, Ashland, Ohio, USA.
Remick AK; WIL Research, a Charles River Company, Hillsborough, North Carolina, USA.
Sutherland VL; NIEHS/NTP, Research Triangle Park, North Carolina, USA.
Thompson KE; Bristol-Myers Squibb, New Brunswick, New Jersey, USA.
Tremblay C; Charles River Laboratories, Senneville, Quebec, Canada.
Yoshida M; Food Safety Commission of Japan, Minato-ku, Tokyo, Japan.
Tomlinson L; Pfizer, Cambridge, Massachusetts, USA.

Toxicol Pathol ; 44(6): 789-809, 2016 08.

Article em En | MEDLINE | ID: mdl-27235322

Assuntos

Avaliação Pré-Clínica de Medicamentos/métodos; Avaliação Pré-Clínica de Medicamentos/normas; Toxicologia/métodos; Toxicologia/normas; Animais; Fidelidade a Diretrizes; Humanos; Patologia Clínica/métodos; Patologia Clínica/normas; Testes de Toxicidade/métodos; Testes de Toxicidade/normas

Palavras-chave

clinical pathology; developmental pathology; preclinical research and development; reproductive system; safety assessment; teratology; toxicologic pathology

Texto completo

Imprimir

XML

PubMed Links

Buscar no Google

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Toxicologia / Avaliação Pré-Clínica de Medicamentos Tipo de estudo: Guideline / Qualitative_research Limite: Animals / Humans Idioma: En Revista: Toxicol Pathol Ano de publicação: 2016 Tipo de documento: Article País de afiliação: Estados Unidos

Texto completo

Imprimir

XML

PubMed Links

Buscar no Google