The Funding of Biopharmaceutical Research and Development

Index

A

American Research & Development Corporation, 167

Applied research, 111

Approval process, 18–27

Approval processes in Asia, 26

Approval processes in Europe, 23

Biologics license application, 20, 94

Clinical trials, 18–27

Contract research organization, 18

European Medicines Agency, 23

Food and Drug Administration, 18

Interventional trials, 19

Investigational new drug, 19

License, 18

Marketing authorization, 18

Ministry of Health, Labour, and Welfare, 27

New drug application, 20, 91

Observational trials, 19

Orphan medicines, 25

State Food and Drug Administration, 26

Tokyo Drug Control Laboratory, 27

B

Basic research, 110

Bayh-Doyle Act, 2, 119–20

Biocenters, 124–6

Bioclusters, 123–24

Biosimilars, 7

Blockbuster drug, 6

Boyer, H., ...