Guidance for Industry: ANDAs: Pharmaceutical Solid Polymorphism

The latest guidance for polymorph.
July 2007
http://www.fda.gov/cder/guidance/7590fnl.pdf

 

1. INTRODUCTION.
2. DEFINITION OF TERMS: POLYMORPHIC FORMS AND POLYMORPHISM
3. GENERAL PRINCIPLES OF PHARMACEUTICAL SOLID POLYMORPHISM
   1. IMPORTANCE OF PHARMACEUTICAL SOLID POLYMORPHISM
   2. CHARACTERIZATION OF POLYMORPHS
   3. INFLUENCE OF POLYMORPHISM ON DRUG SUBSTANCE AND DRUG PRODUCT
      1. Influence on Solubility, Dissolution, and Bioavailability (BA) and Bioequivalence (BE)
      2. Influence on Manufacturing of the Drug Product
      3. Influence on Stability
4. POLYMORPHISM AND SAMENESS IN ANDAs
5. CONSIDERATIONS FOR POLYMORPHISM IN ANDAs
   1. INVESTIGATING THE IMPORTANCE OF SETTING SPECIFICATIONS FOR POLYMORPHS
   2. SETTING SPECIFICATIONS FOR POLYMORPHS IN DRUG SUBSTANCES
   3. INVESTINGATING THE IMPORTANCE OF SETTING SPECIFICATIONS FOR POLYMORPHS IN DRUG PRODUCTS