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
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vii | |
| Preface |
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ix | |
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1 | (8) |
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2 Lead Identification/Optimization |
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9 | (30) |
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3 Oral Drug Formulation Development in Pharmaceutical Lead Selection Stage |
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39 | (50) |
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4 Bridging End of Discovery to Regulatory Filing: Formulations for IND- and Registration-Enabling Nonclinical Studies |
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89 | (26) |
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5 Planning the First Clinical Trials with Clinical Manufacturing Organization (CMO) |
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115 | (24) |
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6 Formulation Strategies for High Dose Toxicology Studies: Case Studies |
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139 | (26) |
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7 Formulation, Analytical, and Regulatory Strategies for First-in-Human Clinical Trials |
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165 | (78) |
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| Index |
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243 | |
Elizabeth Kwong, PhD, retired from Merck & Co., Inc. in 2011, after 23 years of service. She then established her own company, Kwong Eureka Solutions, as a consultant for small start-up companies and specialty drug products. Dr. Kwong is on the Board of Directors for the Canadian Society of Pharmaceutical Scientists and is also an adjunct professor in the Department of Pharmaceutics at the University of Montreal and Department of Chemistry at Concordia University. More recently, Dr. Kwong also co-founded a start-up company, Giiant Pharma, working on delivering a colon specific PDEIV Inhibitor prodrug for the treatment of ulcerative colitis.
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