Abstract
In practical terms, there really are two questions:
-
A.
How does one achieve approval for a drug for even the most limited indication? and
-
B.
How does one get approval for the indication of preventing coronary heart disease?
This is a preview of subscription content, log in via an institution to check access.
Access this chapter
Tax calculation will be finalised at checkout
Purchases are for personal use only
Editor information
Editors and Affiliations
Rights and permissions
Copyright information
© 1989 Kluwer Academic Publishers
About this chapter
Cite this chapter
Sobel, S. (1989). What is Required to Gain Approval of Lipid Altering Drugs?. In: Morganroth, J., Moore, E.N. (eds) Risk/Benefit Analysis for the Use and Approval of Thrombolytic, Antiarrhythmic, and Hypolipidemic Agents. Developments in Cardiovascular Medicine, vol 100. Springer, Boston, MA. https://doi.org/10.1007/978-1-4613-1605-3_17
Download citation
DOI: https://doi.org/10.1007/978-1-4613-1605-3_17
Publisher Name: Springer, Boston, MA
Print ISBN: 978-1-4612-8888-6
Online ISBN: 978-1-4613-1605-3
eBook Packages: Springer Book Archive