http://www.loc.gov/mods/v3 http://www.loc.gov/standards/mods/v3/mods-3-2.xsd
Drug and Biological Development: From Molecule to Product and Beyond offers a complete discussion of product development in the pharmaceutical and biotechnology industries from discovery to product launch, continuing through life cycle management. The book is organized for optimal usefulness in the education and training of health care professionals. The text's narrative descriptions are enhanced by real-life examples, illustrations, controversies in industry, and references. Dr. Ronald Evens and his contributors are industry and research experts in a variety of disciplines.
Health Care and Industry Overview and Challenges -- R&D Planning and Governance -- R&D Outcomes -- Discovery and Nonclinical Development -- Types of Clinical Studies -- Metabolism and Pharmacokinetics -- Laws and Regulations: The Discipline of Regulatory Affairs -- Clinical Trial Operations -- Formulation and Manufacturing -- Commercial Division -- Medical Affairs and Professional Services -- Special Considerations in Research.