國立高雄大學圖資館 |

Language: English

Back

Bioequivalence requirements in vario...

Kanfer, Isadore.

Bioequivalence requirements in various global jurisdictions

Record Type:	Electronic resources : Monograph/item
Title/Author:	Bioequivalence requirements in various global jurisdictionsedited by Isadore Kanfer.
other author:	Kanfer, Isadore.
Published:	Cham :Springer International Publishing :2017.
Description:	x, 345 p. :ill., digital ;24 cm.
Contained By:	Springer eBooks
Subject:	DrugsTherapeutic equivalency.
Online resource:	http://dx.doi.org/10.1007/978-3-319-68078-1
ISBN:	9783319680781$q(electronic bk.)

Bioequivalence requirements in various global jurisdictions
Bioequivalence requirements in various global jurisdictions[electronic resource] /edited by Isadore Kanfer. - Cham :Springer International Publishing :2017. - x, 345 p. :ill., digital ;24 cm. - AAPS advances in the pharmaceutical sciences series,v.282210-7371 ;. - AAPS advances in the pharmaceutical sciences series ;3..

Brazil -- Canada -- China -- The European Union -- India -- Bioequivalence Studies in Japan -- Middle East and North Africa (MENA) Bioequivalence Requirements -- Russia -- South Africa -- The United States of America -- World Health Organization (WHO)

Although the Bioequivalence (BE) requirements in many global jurisdictions have much in common, differences in certain approaches and requirements such as definitions and terms, choice of comparator (reference) product, acceptance criteria, fasted and fed studies, single and multi-dose studies, biowaivers and products not intended for absorption into the systemic circulation (locally acting medicines and dosage forms), amongst others, provide food for thought that standardisation should be a high priority objective in order to result in a harmonized international process for the market approval of products using BE. An important objective of Bioequivalence Requirements in Various Global Jurisdictions is to attempt to gather the various BE requirements used in different global jurisdictions to provide a single source of relevant information. This information from, Brazil, Canada, China, European Union, India, Japan, MENA, Russia South Africa, the USA and WHO will be of value to drug manufacturers, regulatory agencies, pharmaceutical scientists and related health organizations and governments around the world in the quest to harmonize regulatory requirements for the market approval of generic products.

ISBN: 9783319680781$q(electronic bk.)

Standard No.: 10.1007/978-3-319-68078-1doiSubjects--Topical Terms:

265612
Drugs
--Therapeutic equivalency.

LC Class. No.: RM301.45

Dewey Class. No.: 615.1

Bioequivalence requirements in various global jurisdictions
LDR:02513nmm a2200325 a 4500 001 525626
003 DE-He213
005 20171205202306.0
006 m d
007 cr nn 008maaau
008 180918s2017 gw s 0 eng d
020 $a 9783319680781$q(electronic bk.)
020 $a 9783319680774$q(paper)
024 7 $a 10.1007/978-3-319-68078-1 $2 doi
035 $a 978-3-319-68078-1
040 $a GP $c GP
041 0 $a eng
050 4 $a RM301.45
072 7 $a TDCW $2 bicssc
072 7 $a MED072000 $2 bisacsh
082 0 4 $a 615.1 $2 23
090 $a RM301.45 $b .B615 2017
245 0 0 $a Bioequivalence requirements in various global jurisdictions $h [electronic resource] / $c edited by Isadore Kanfer.
260 $a Cham : $b Springer International Publishing : $b Imprint: Springer, $c 2017.
300 $a x, 345 p. : $b ill., digital ; $c 24 cm.
490 1 $a AAPS advances in the pharmaceutical sciences series, $x 2210-7371 ; $v v.28
505 0 $a Brazil -- Canada -- China -- The European Union -- India -- Bioequivalence Studies in Japan -- Middle East and North Africa (MENA) Bioequivalence Requirements -- Russia -- South Africa -- The United States of America -- World Health Organization (WHO)
520 $a Although the Bioequivalence (BE) requirements in many global jurisdictions have much in common, differences in certain approaches and requirements such as definitions and terms, choice of comparator (reference) product, acceptance criteria, fasted and fed studies, single and multi-dose studies, biowaivers and products not intended for absorption into the systemic circulation (locally acting medicines and dosage forms), amongst others, provide food for thought that standardisation should be a high priority objective in order to result in a harmonized international process for the market approval of products using BE. An important objective of Bioequivalence Requirements in Various Global Jurisdictions is to attempt to gather the various BE requirements used in different global jurisdictions to provide a single source of relevant information. This information from, Brazil, Canada, China, European Union, India, Japan, MENA, Russia South Africa, the USA and WHO will be of value to drug manufacturers, regulatory agencies, pharmaceutical scientists and related health organizations and governments around the world in the quest to harmonize regulatory requirements for the market approval of generic products.
650 0 $a Drugs $x Therapeutic equivalency. $3 265612
650 1 4 $a Biomedicine. $3 273648
650 2 4 $a Pharmaceutical Sciences/Technology. $3 338426
700 1 $a Kanfer, Isadore. $3 302857
710 2 $a SpringerLink (Online service) $3 273601
773 0 $t Springer eBooks
830 0 $a AAPS advances in the pharmaceutical sciences series ; $v 3. $3 559046
856 4 0 $u http://dx.doi.org/10.1007/978-3-319-68078-1
950 $a Biomedical and Life Sciences (Springer-11642)