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Generic drug product development = solid oral dosage forms /

紀錄類型:	書目-語言資料,印刷品 : Monograph/item
正題名/作者:	Generic drug product development/ edited by Leon Shargel, Isadore Kanfer.
其他題名:	solid oral dosage forms /
其他作者:	Shargel, Leon,
出版者:	Boca Raton, FL :CRC Press/Taylor & Francis Group, : c2014.,
面頁冊數:	1 online resource (xii, 385 p.) :ill. :
標題:	Generic drugs. -
電子資源:	http://www.crcnetbase.com/isbn/9781420086362
ISBN:	9781420086362 (electronic bk.)

Generic drug product development = solid oral dosage forms /
Generic drug product developmentsolid oral dosage forms /[electronic resource] :edited by Leon Shargel, Isadore Kanfer. - 2nd ed. - Boca Raton, FL :CRC Press/Taylor & Francis Group,c2014. - 1 online resource (xii, 385 p.) :ill. - Drugs and the pharmaceutical sciences ;129.

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.

"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.

ISBN: 9781420086362 (electronic bk.)

LCCN: 2013014696Subjects--Topical Terms:

583185
Generic drugs.

LC Class. No.: RS55.2 / .G455 2014

Dewey Class. No.: 615/.19

National Library of Medicine Call No.: W1 / DR893B v.129 2014

Generic drug product development = solid oral dosage forms /
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490 0 $a Drugs and the pharmaceutical sciences ; $v 129
504 $a Includes bibliographical references and index.
505 0 $a 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.
520 $a "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.
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700 1 $a Kanfer, Isadore. $3 583395
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