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Oral Formulation Roadmap from Early Drug Discovery to Development

Oral Formulation Roadmap from Early Drug Discovery to Development

Elizabeth Kwong (Editor)

ISBN: 978-1-118-90733-7

Feb 2017

272 pages

In Stock

$150.00

Description

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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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