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Pharmaceutical toxicology in practice : a guide for non-clinical development /

This book describes, with references to key source materials, €the background to, and conduct of, the principal nonclinical studies€that are central to drug development. The chapters provide an understanding of the key components of the preclinical phase of drug development with a hands-on descripti...

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Detalles Bibliográficos
Clasificación:Libro Electrónico
Otros Autores: Lodola, Alberto, Stadler, Jeanne
Formato: Electrónico eBook
Idioma:Inglés
Publicado: Hoboken, N.J. : Wiley, ©2011.
Temas:
Acceso en línea:Texto completo
Tabla de Contenidos:
  • Frontmatter
  • Introduction / Alberto Lodola, Jeanne Stadler
  • The Regulatory Environment / Claudio Bernardi, Marco Brughera
  • Toxicological Development: Roles and Responsibilities / Franck Chuzel, Bernard Ruty
  • Contract Research Organizations / Maurice Cary
  • Safety Pharmacology / Claudio Arrigoni, Valeria Perego
  • Formulations, Impurities, and Toxicokinetics / Claude Charuel
  • General Toxicology / Alberto Lodola
  • Genetic Toxicology / Peggy Guzzie-Peck, Jennifer C Sasaki, Sandy K Weiner
  • Developmental and Reproductive Toxicology / Jeanne Stadler
  • Data Analysis, Report Writing, and Regulatory Documentation / Monique Y Wells
  • Risk Management / Alberto Lodola
  • Index.
  • Introduction / Alberto Lodola and Jeanne Stadler
  • The regulatory environment / Claudio Bernardi and Marco Brughera
  • Toxicological development : roles and responsibilities / Franck Chuzel and Bernard Ruty
  • Contract research organizations / Maurice Cary
  • Safety pharmacology / Claudio Arrigoni and Valeria Perego
  • Formulations, impurities, and toxicokinetics / Claude Charuel
  • General toxicology / Alberto Lodola
  • Genetic toxicology / Peggy Guzzie-Peck, Jennifer C. Sasaki, and Sandy K. Weiner
  • Developmental and reproductive toxicology / Jeanne Stadler
  • Data analysis, report writing, and regulatory documentation / Monique Y. Wells
  • Risk management / Alberto Lodola.