| Popis: |
Introduction to Generic Drug Development Leon Shargel and Izzy Kanfer Active Pharmaceutical Ingredients Edward Cohen and Lih-Yang Lin Analytical Methods Development and Validation Nicholas Cappuccino Experimental Formulation Development Izzy Kanfer, Peter H.R. Persicaner, and Roderick B. Walker Scale-up, Technology Transfer and Validation Salah U. Ahmed, Venkatesh Naini, and Dilip Wadgaonker Product Stability Pranab K. Bhattacharyya Quality Control and Quality Assurance Loren Gelber and Joan Janulis Drug Product Performance, In Vitro Pradeep Sathe, Larry Ouderkirk, Ajaz Hussain, and Lawrence X.Yu ANDA Regulatory Approval Process Timothy W. Ames, Karen A. Bernard, Beth Fabian Fritsch, Koung Lee, Aida L. Sanchez, Krista M. Scardina, and Martin Shimer Bioequivalence and Drug Product. |
