國立高雄大學圖資館 |

語系: 繁體中文

說明(常見問題)

圖資館首頁

登入

回首頁 到查詢結果 [ subject:"Generic drugs." ]

切換: 標籤 | MARC模式 | ISBD

Generic drug product developmentsoli...

Kanfer, Isadore.

Generic drug product developmentsolid oral dosage forms /

紀錄類型:	書目-電子資源 : Monograph/item
正題名/作者:	Generic drug product developmentedited 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 developmentsolid 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:

302680
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 developmentsolid oral dosage forms /
LDR:02812cmm a22003134a 4500 001 485971
005 20140605143349.0
006 m o d
007 cr |n|---|||||
008 161104s2014 flua ob 001 0 eng
010 $a 2013014696
020 $a 9781420086362 (electronic bk.)
020 $z 9781420086355 (hbk.)
035 $a (DNLM)101606012
035 $a 17694826
040 $a DNLM/DLC $c DLC $d DLC
050 0 0 $a RS55.2 $b .G455 2014
060 1 0 $a W1 $b DR893B v.129 2014
060 1 0 $a QV 771
082 0 0 $a 615/.19 $2 23
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 302680
650 0 $a Solid dosage forms. $3 302713
650 1 2 $a Drugs, Generic $x standards. $3 520213
650 2 2 $a Chemistry, Pharmaceutical $x standards. $3 743491
650 2 2 $a Drug Approval. $3 226662
650 2 2 $a Tablets. $3 569864
700 1 $a Shargel, Leon, $d 1941- $3 302856
700 1 $a Kanfer, Isadore. $3 302857
856 4 0 $u http://www.crcnetbase.com/isbn/9781420086362