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Oral Formulation Roadmap from Early Drug Discovery to Development, 1ed

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Many of the challenges facing drug discovery and development stem from a failure to properly identify formulations that translate from preclinical to clinical phases. Further, a lack of collaboration and proper integration between formulation and discovery scientists contribute significantly to most failures in the clinic. Lastly, the regulatory requirements for formulations also increase the timelines and costs of bringing a drug candidate forward.

Written to address these many challenges and issues, this book describes and explains the key factors that help determine the types of formulation needed throughout the stages of drug discovery. Detailing formulation approaches by stage of discovery to early development, Oral Formulation Roadmap from Early Drug Discovery to Development gives a “playbook” of practical and efficient strategies to formulate drug candidates with the least chance of failing in clinical development.

A key reference for practicing pharmaceutical scientists, this book provides a valuable resource that:

• 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

• Covers regulatory filing, drug metabolism and properties, biopharmaceutics classification system (BCS), screening approaches, toxicology studies, clinical formulation development, and outsourcing

About the Author

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.

Contents

۱ Introduction
۲ Lead Identification/Optimization
۳ Oral Drug Formulation Development in Pharmaceutical Lead Selection Stage
۴ Bridging End of Discovery to Regulatory Filing: Formulations for INDand Registration-Enabling Nonclinical Studies
۵ Planning the First Clinical Trials with Clinical Manufacturing Organization (CMO)
۶ Formulation Strategies for High Dose Toxicology Studies: Case Studies
۷ Formulationr Analytical, and Regulatory Strategies for First-in-Human Clinical Trials

قیمت : 2000 تومان
لینک کوتاه : https://bookbaz.ir/?p=53335
نویسنده : Elizabeth Kwong
ناشر : Wiley; 1 edition
سال انتشار : 2017
زبان کتاب : انگلیسی
نوع فایل : PDF
تعداد صفحات : 272
(ISBN) شابک : 1118907337
قیمت کتاب درآمازون : $150.00
حجم فایل : 3 MB

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۲۰۰۰ تـومان – خرید