Fundamentals of drug development / Jeffrey S. Barrett.

Format:

Book

Author/Creator:

Barrett, Jeffrey S., author.

Series:

Wiley Online Library ebooks.

Language:

English

Subjects (All):

Pharmacology.

Physical Description:

1 online resource (512 pages)

Place of Publication:

Hoboken, New Jersey : Wiley, [2022]

Summary:

"This book discusses how to conduct pharmaceutical research and the context for how the industry fits into global healthcare. Holistically, the well-qualified author helps readers and students of drug development appreciate the time and expense of the process. Specifically, the work identifies the emerging trends shaping the future of drug development, along with important related topics like generic drugs, data sharing, and collaboration. To aid in seamless reader comprehension, the book includes a glossary of terms and a self-assessment quiz for each chapter at the end. PowerPoint slides are also available as an online ancillary for adopting professors"-- Provided by publisher.

Contents:

The history of drug development

The modern pharmaceutical industry : big and small pharma, biotechnology companies, and generic drug makers

Legal considerations, intellectual property, patents and patent protection

The global regulatory landscape

Phases of drug development : old and new paradigms

Discovery / preclinical

Phase I

Phase II

Phase III

Phase IV, special populations and post marketing commitments

Role and function of project teams

Compound progression and go / no go criteria

Regulatory milestones and the submission process

Life cycle management

Formulation development

Chemistry and manufacturing (CMC)

Health economics and the healthcare industry

Current state of affairs : attrition rates and evolving corporate strategies

Medical devices

Distribution and the supply chain

Sales, marketing and advertising

Generic drugs and the generic industry

The generic approval process

Data sharing and collaboration

The future of the pharmaceutical industry.

Notes:

Includes bibliographical references and index

Includes bibliographical references and index.

Description based on print version record.

ISBN:

1-119-91327-6

1-119-69173-7

1-119-69170-2

OCLC:

1336990538