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...
Άλλοι συγγραφείς: | , |
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Μορφή: | Ηλ. βιβλίο |
Γλώσσα: | English |
Έκδοση: |
Hoboken, N.J. :
Wiley,
[2011]
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Θέματα: | |
Διαθέσιμο Online: | Full Text via HEAL-Link |
Πίνακας περιεχομένων:
- 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.