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Generic drug product development : solid oral dosage forms / [edited by] Leon Shargel, Isadore Kanfer.

Contributor(s): Material type: TextTextSeries: Drugs and the pharmaceutical sciences ; v. 143Publisher: New York : Marcel Dekker, [2005]Copyright date: ©2005. Description: xi, 381 pages : illustrations ; 24 cmContent type:
  • text
Media type:
  • unmediated
Carrier type:
  • volume
ISBN:
  • 0824754603 (hbk. : alk. paper)
Subject(s): DDC classification:
  • 22 615.19 G
LOC classification:
  • RS55.2 .G455 2005
Online resources:
Contents:
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.
Summary: 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.
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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.

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.

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