Oral Formulation Roadmap from Early Drug Discovery to Development

ISBN-13: 9781118907337 / Angielski / Twarda / 2017 / 272 str.

Elizabeth Kwong

Opis

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

Spis treści

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

O autorze

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.

Blurb

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