‏874.00 ₪

Oral Formulation Roadmap from Early Drug Discovery to Development

‏874.00 ₪
ISBN13
9781118907337
יצא לאור ב
New York
זמן אספקה
21 ימי עסקים
עמודים
272
פורמט
Hardback
תאריך יציאה לאור
24 במרץ 2017
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.
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
מידע נוסף
עמודים 272
פורמט Hardback
ISBN10 1118907337
יצא לאור ב New York
תאריך יציאה לאור 24 במרץ 2017
תוכן עניינים List of Contributors vii Preface ix 1 Introduction 1 Elizabeth Kwong 2 Lead Identification/Optimization 9 Mei Wong and Mark McAllister 3 Oral Drug Formulation Development in Pharmaceutical Lead Selection Stage 39 Shayne Cox Gad 4 Bridging End of Discovery to Regulatory Filing: Formulations for IND-and Registration -Enabling Nonclinical Studies 89 Evan A. Thackaberry 5 Planning the First Clinical Trials with Clinical Manufacturing Organization (CMO) 115 Elizabeth Kwong and Caroline McGregor 6 Formulation Strategies for High Dose Toxicology Studies: Case Studies 139 Dennis H. Leung, Pierre Daublain, Mengwei Hu and Kung ]I Feng 7 Formulation, Analytical, and Regulatory Strategies for First -in-Human Clinical Trials 165 Lorenzo Capretto, Gerard Byrne, Sarah Trenfield, Lee Dowden and Steven Booth Index 243
זמן אספקה 21 ימי עסקים