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Oral formulation roadmap from early drug discovery to development / edited by Elizabeth Kwong.
- Format:
- Book
- Language:
- English
- Subjects (All):
- Drug development.
- Drugs.
- Physical Description:
- 1 online resource (267 pages) : illustrations (some color), tables
- Edition:
- 1st ed.
- Place of Publication:
- Hoboken, New Jersey : Wiley, 2017.
- Summary:
- 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
- Contents:
- 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.
- Notes:
- Includes bibliographical references at the end of each chapters and index.
- Description based on print version record.
- ISBN:
- 9781118907900
- 1118907906
- 9781118907870
- 1118907876
- 9781118907894
- 1118907892
- OCLC:
- 967938447
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