Generic drug product development : solid oral dosage forms
by
Shargel, Leon, 1941-
Title
:
Generic drug product development : solid oral dosage forms
Author
:
Shargel, Leon, 1941-
ISBN
:
9780824754600
Publication Information
:
New York : Marcel Dekker, c2005.
Physical Description
:
xi, 381 s. : res. ; 24 cm.
Series
:
Drugs and the pharmaceutical sciences ; v. 143
Series Title
:
Drugs and the pharmaceutical sciences ; v. 143
Contents
:
Introduction to generic drug product development / Active pharmaceutical ingredients / Analytical methods development and methods validation for solid oral dosage forms / Experimental formulation development / Scale-up, process validation, and technology transfer / Drug stability / Quality control and quality assurance / Drug product performance, in vitro / ANDA regulatory approval process / Bioequivalence and drug product assessment, in vivo / Statistical considerations for establishing bioequivalence / Scale-up, post-approval changes, and post-marketing surveillance / Outsourcing bioavailability and bioequivalence studies to contract research organizations / Legal and legislative hurdles to generic drug development, approval, and marketing
Subject Term
:
İlaçlar, Jenerik
Tabletler
İlaç Onayı
Drugs, Generic
Tablets
Drug Approval
Added Author
:
Shargel, Leon, 1941-
Kanfer, Isadore.
Library | Material Type | Item Barcode | Shelf Number | [[missing key: search.ChildField.HOLDING]] | Status |
---|
Health Sciences Library | Book | 7.2/12/402246 | QV 704 D8426 2005 | | Sağlık Bilimleri Genel Koleksiyon |