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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

MARC

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245 0 0 |a Oral formulation roadmap from early drug discovery to development /  |c edited by Elizabeth Kwong. 
264 1 |a Hoboken, NJ :  |b John Wiley & Sons Inc.,  |c 2017. 
264 4 |c ©2017 
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520 |a 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 formulations on the frontlines of the pharmaceutical industry. Focuses on pre (or non- ) clinical and early stage development, the phases where most compounds are used in drug research. Features case studies to illustrate practical challenges and solutions in formulation selection. Covers regulatory filing, drug metabolism and physical and chemical properties, toxicology formulation, biopharmaceutics classification system (BCS), screening approaches, early stage clinical formulation development, and outsourcing. 
504 |a Includes bibliographical references and index. 
505 0 |a 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. 
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650 0 |a Drug development. 
650 0 |a Drugs  |x Dosage forms. 
650 2 |a Drug Discovery 
650 2 |a Chemistry, Pharmaceutical  |x methods 
650 2 |a Clinical Trials as Topic 
650 2 |a Dosage Forms 
650 2 |a Administratoin, Oral 
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650 6 |a Médicaments  |x Formes pharmaceutiques. 
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650 7 |a Drugs  |x Dosage forms  |2 fast 
650 7 |a Drug development  |2 fast 
655 4 |a Internet Resources. 
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