TY  - BOOK
AU  - edited by Shargel, Leon
AU  - Shargel,Leon
AU  - Kanfer,Isadore
TI  - Generic drug product development: solid oral dosage forms 
T2  - Drugs and the pharmaceutical sciences
SN  - 9781420086355 (hbk. : alk. paper)
AV  - RS55.2 .G455 2014
U1  - 615.19 SHA-L 23
PY  - 2014///
CY  - Boca Raton
PB  - CRC Press
KW  - Generic drugs
KW  - Solid dosage forms
KW  - Drugs, Generic
KW  - standards
KW  - Chemistry, Pharmaceutical
KW  - Drug Approval
KW  - Tablets
N1  - Includes bibliographical references and index; Active pharmaceutical ingredient / Edward M. Cohen, Steven Sutherland -- Analytical methods development and methods validation for solid oral dosage forms / Quanyin Gao, Dilip R. Sanvordeker -- Experimental formulation development / Isadore Kanfer ... [et al.] -- Scale-up, technology transfer, and process performance qualification / Salah U. Ahmed ... [et al.] -- Drug stability / Pranab K. Bhattacharyya -- Quality control and quality assurance / Loren Gelber -- Drug product performance, in vitro / Pradeep M. Sathe, John Duan, and Lawrence X. Yu -- ANDA regulatory approval process / Timothy W. Ames, Aaron Sigler -- Bioequivalence and drug product assessment, in vivo / Barbara M. Davit, Dale P, Conner -- Statistical considerations for establishing bioequivalence / Charles Bon, Sanford Bolton -- Outsourcing bioavailability and bioequivalence studies to contract research organizations / Patrick K. Noonan -- Post-approval changes and post-marketing surveillance / Lorien Armour, Leon Shargel -- United States Pharmacopeia-National Formulary : its history, organization, and role in harmonization / William Brown, Margareth R.C. Marques -- Legal and legislative hurdles to generic drug development, approval and marketing / Arthur T. Tsien
N2  - "This book collects in-depth discussions from more than 30 noted specialists on topics such as quality control, experimental formulations, pharmaceutical ingredients, conventional and modified-release products, and bioequivalence. It considers key elements in the formulation of generic drug products including the availability of raw materials and chemical purity. It contains new chapters on experimental formulation development, and the relationship between the FDA and the United States Pharmacopeia"--Provided by publisher
ER  -