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Generic drug product development[electronic resource] :solid oral dosage forms /

紀錄類型:	書目-語言資料,印刷品 : Monograph/item
杜威分類號:	615/.19
書名/作者:	Generic drug product development : solid oral dosage forms // edited by Leon Shargel, Isadore Kanfer.
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.
標題:	Solid dosage forms.
標題:	Drugs, Generic - standards.
標題:	Chemistry, Pharmaceutical - standards.
標題:	Drug Approval.
標題:	Tablets.
ISBN:	9781420086362 (electronic bk.)
書目註:	Includes bibliographical references and index.
內容註:	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.
摘要、提要註:	"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.
電子資源:	http://www.crcnetbase.com/isbn/9781420086362

Generic drug product development[electronic resource] :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:

437927
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[electronic resource] :solid oral dosage forms /
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245 0 0 $a Generic drug product development $h [electronic resource] : $b solid oral dosage forms / $c edited by Leon Shargel, Isadore Kanfer.
250 $a 2nd ed.
260 $a Boca Raton, FL : $b CRC Press/Taylor & Francis Group, $c c2014.
300 $a 1 online resource (xii, 385 p.) : $b ill.
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.
588 $a Description based on print version record.
650 0 $a Generic drugs. $3 437927
650 0 $a Solid dosage forms. $3 431512
650 1 2 $a Drugs, Generic $x standards. $3 437930
650 2 2 $a Chemistry, Pharmaceutical $x standards. $3 657205
650 2 2 $a Drug Approval. $3 553525
650 2 2 $a Tablets. $3 489414
700 1 $a Shargel, Leon, $d 1941- $3 437926
700 1 $a Kanfer, Isadore. $3 437925
856 4 0 $u http://www.crcnetbase.com/isbn/9781420086362