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Oral formulation roadmap from early drug discovery to development /

Detailing formulation approaches by stage of discovery to early development, this book gives a "playbook" of practical and efficient strategies to formulate drug candidates with the least chance of failing in clinical development. Comes from contributing authors with experience developing...

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Detalles Bibliográficos
Clasificación:Libro Electrónico
Otros Autores: Kwong, Elizabeth, 1954- (Editor )
Formato: Electrónico eBook
Idioma:Inglés
Publicado: Hoboken, NJ : John Wiley & Sons Inc., 2017.
Temas:
Acceso en línea:Texto completo
Tabla de Contenidos:
  • Introduction / Elizabeth Kwong
  • Lead identification/optimization / Dr. Mei Wong And Dr. Mark Mcallister
  • Oral drug formulation development in pharmaceutical lead selection stage / Shayne Cox Gad
  • Bridging end of discovery to regulatory filing : formulations for IND- and registration-enabling nonclinical studies / Evan A. Thackaberry
  • Planning the first clinical trials with clinical manufacturing organization (CMO) / Elizabeth Kwong and Caroline McGregor
  • Formulation strategies for high dose toxicology studies : case studies / Dennis H. Leung, Pierre Daublain, Mengwei Hu, Kung-I Feng
  • Formulation, analytical and regulatory strategies for first in human clinical trials / Lorenzo Capretto, Gerard Byrne, Sarah Trenfield, Lee Dowden, and Steven Booth.