TY  - BOOK
AU  - Shargel,Leon
AU  - Kanfer,Isadore
TI  - Generic drug product development: solid oral dosage forms 
SN  - 0824754603 (hbk. : alk. paper)
AV  - RS55.2 .G455 2005
U1  - 615.19 22
PY  - 2005///]
CY  - New York
PB  - Marcel Dekker
KW  - Generic drugs
KW  - Solid dosage forms
N1  - Includes bibliographical references and index; 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

N2  - Describes the development of solid oral generic drug products from project initiation to market approval - collecting discussions from more than 30 noted specialists on topics such as quality control and quality assurance, experimental formulation, pharmaceutical ingredients, drug delivery, and bioequivalence
UR  - http://www.loc.gov/catdir/enhancements/fy0647/2005040476-d.html
ER  -