Generic Drug Product Development
Solid Oral Dosage Forms
1. Auflage
Erschienen am 1. Dezember 2004
Buch
Hardcover
408 Seiten
978-0-8247-5460-0 (ISBN)
Beschreibung
Keeping pace with the latest technologies in the field, this guide describes the development of solid oral generic drug products from project initiation to market approval. Focusing on immediate-release and modified-release dosage forms, the book collects in-depth discussions from more than 30 noted specialists on topics such as quality control, experimental formulation, pharmaceutical ingredients, and bioequivalence, and considers key elements in the formulation of generic drug products including the availability of raw materials, chemical purity. It also highlights constraints in generic drug development that differ from the formulation design of a brand name pharmaceutical product.
Weitere Details
Reihe
Sprache
Englisch
Verlagsort
New York
USA
Verlagsgruppe
Taylor & Francis Inc
Zielgruppe
Für Beruf und Forschung
Pharmacists; pharmacologists; clinical investigators; pharmaceutical industry professionals involved in clinical, regulatory, statistical, and legal development of generic drugs; and graduate and upper-level undergraduate students who intend to pursue careers in the pharmaceutical industry
Illustrationen
5 s/w Photographien bzw. Rasterbilder
5 Halftones, black and white
Maße
Höhe: 229 mm
Breite: 152 mm
Gewicht
658 gr
ISBN-13
978-0-8247-5460-0 (9780824754600)
Copyright in bibliographic data is held by Nielsen Book Services Limited or its licensors: all rights reserved.
Schweitzer Klassifikation
Weitere Ausgaben
Nachauflagen
Leon Shargel | Isadore Kanfer
Generic Drug Product Development
Solid Oral Dosage Forms, Second Edition
Buch
10/2013
2. Auflage
CRC Press
302,50 €
Versand in 15-20 Tagen
Andere Ausgaben
E-Book
10/2014
CRC Press
53,99 €
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Inhalt
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.