Previous edition: New York: Informa Healthcare, 2009.

<P><STRONG>Part I. Regulatory and Manufacturing Guidelines</STRONG></P><P>Chapter 1. U.S. FDA Good Manufacturing Practices</P><P>Chapter 2. Guideline on the Common Technical Document for the Registration of Pharmaceuticals for Human Use</P><P>Chapter 3. Process Validation: General Principles and Practices</P><P>Chapter 4. Bioequivalence Regulatory Compliance</P><P>Chapter 5. Bioequivalence Regulatory Review Process and Audit</P><P>Chapter 6. EU Guidelines to Good Manufacturing Practice: Active Drug Substance</P><P>Chapter 7. FDA Pre-approval Inspections</P><P>Chapter 8. Formulation Factors in Uncompressed Dosage Forms</P><P>Chapter 9: Solid-State Properties.</P><P>Chapter 10: Formulation of Flavor.</P><P><STRONG>Part II. Manufacturing Formulations</STRONG></P><P>Uncompressed Solids Formulations</P><P><STRONG>Part III. Commercial Pharmaceutical Formulations.</STRONG></P><P>Commercial Pharmaceutical Formulations.</P>

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