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

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