The influence of market exclusivity on drug availability and medical innovations
Journal Title: The AAPS Journal - Year 2007, Vol 9, Issue 3
Abstract
The interpretation and application of intellectual property laws is enormously complex in the pharmaceutical industry, with companies needing to obtain multiple patents to fully protect their innovations. While patents provide important incentives for biomedical innovation and ecoinomic growth, concern has been expressed over the growing number of patents, the granting of patents on basic research tools (eg, genetically engineered animals), and the possibility that these legal protections may ultimately inhibit scientific advancement.
Authors and Affiliations
Gregory J. Glover
Nonclinical Dose Formulation: Out of Specification Investigations
Nonclinical safety studies are required to follow applicable Good Laboratory Practice (GLP) regulations. Nonclinical dose formulations are required to be analyzed to confirm the analyte concentration, homogeneity, and st...
A Bioequivalence Approach for Generic Narrow Therapeutic Index Drugs: Evaluation of the Reference-Scaled Approach and Variability Comparison Criterion
Various health communities have expressed concerns regarding whether average bioequivalence (BE) limits (80.00–125.00%) for the 90% confidence interval of the test-to-reference geometric mean ratio are sufficient...
Epigenetic Cancer Prevention Mechanisms in Skin Cancer
Epigenetics is an important emerging area for study of mechanisms of cancer prevention. In recent years, it has been realized that cancer prevention agents, derived from natural dietary sources, impact cancer cell surviv...
Etoposide-incorporated tripalmitin nanoparticles with different surface charge: Formulation, characterization, radiolabeling, and biodistribution studies
Etoposide-incorporated tripalmitin nanoparticles with negative (ETN) and positive charge (ETP) were prepared by melt emulsification and high-pressure homogenization techniques. Spray drying of nanoparticles led to free f...
Independence of substituent contributions to the transport of small-molecule permeants in lipid bilayer
Purpose: To explore the independence of functional group contributions to permeability of nonelectrolytes across egg lecithin bilayers. Methods. The transport rates were measured of a series of α-substituted p-me...