Regulatory considerations of pharmaceutical solid polymorphism in Abbreviated New Drug Applications (ANDAs).

Raw, Andre S

Regulatory considerations of pharmaceutical solid polymorphism in Abbreviated New Drug Applications (ANDAs). [electronic resource] - Advanced drug delivery reviews Feb 2004 - 397-414 p. digital

Publication Type: Journal Article; Review

0169-409X

10.1016/j.addr.2003.10.011 doi


Biological Availability
Carbamazepine--chemistry
Cefuroxime--analogs & derivatives
Chemistry Techniques, Analytical
Crystallography
Decision Trees
Drug Approval--methods
Drug Stability
Drugs, Generic--chemistry
Enalapril--chemistry
Humans
Molecular Conformation
Phase Transition
Prazosin--analogs & derivatives
Quality Control
Ranitidine--chemistry
Solubility
Sulfonamides--chemistry
Technology, Pharmaceutical
Therapeutic Equivalency
Torsemide
United States
United States Food and Drug Administration
Warfarin--chemistry