Early drug development : strategies and routes to first-in-human trials /

The focus of early drug development has been the submission of an Investigational New Drug application to regulatory agencies. Early Drug Development: Strategies and Routes to First-in-Human Trials guides drug development organizations in preparing and submitting an Investigational New Drug (IND) ap...

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Detalles Bibliográficos
Clasificación:Libro Electrónico
Otros Autores: Cayen, M. N.
Formato: Electrónico eBook
Idioma:Inglés
Publicado: Hoboken, N.J. : Wiley, ©2010.
Temas:
Drug development.
Drug Discovery > methods
Clinical Trials, Phase I as Topic
Drug Approval > organization & administration
Drugs, Investigational > therapeutic use
Research Design
Médicaments > Développement.
MEDICAL > Drug Guides.
MEDICAL > Pharmacology.
MEDICAL > Pharmacy.
MEDICAL > Nursing > Pharmacology.
Drug development
Acceso en línea:Texto completo
Tabla de Contenidos:
  • Drug discovery and early drug development / Mitchell N. Cayen
  • ADME strategies in lead optimization / Amin A. Nomeir
  • Prediction of pharmacokinetics and drug safety in humans / Peter L. Bullock
  • Bioanalytical strategies / Christopher Kemper
  • Chemistry, manufacturing and controls : the drug substance and formulated drug product / Orn Almarsson and Christopher J. Galli
  • Nonclinical safety pharmacology studies recommended for support of first-in-human clinical trials / Duane B. Lakings
  • Toxicology program to support initiation of a clinical phase I program for a new medicine / Hugh E. Black, Stephen B. Montgomery, and Ronald W. Moch
  • Toxicokinetics in support of drug development / Gary Eichenbaum, Vangala Subrahmanyam, and Alfred P. Tonelli
  • Good laboratory practice / Anthony B. Jones, Kathryn Hackett-Fields, and Shari L. Perlstein
  • Estimation of human starting dose for phase I clinical programs / Lorrene A. Buckley [and others]
  • Exploratory INDS/CTAS / Mitchell N. Cayen
  • Unique considerations for biopharmaceutics / Laura P. Andrews and James D. Green
  • Project management and international regulatory requirements for first-in-human trials / Carolyn D. Finkle and Judith Atkins
  • First-in-human regulatory submissions / Mary M. Sommer [and others].

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