東華大學圖書館 |

Language: English

Help

回圖書館首頁

手機版館藏查詢

Back

Switch To: Labeled | MARC Mode | ISBD

Bioequivalence requirements in vario...

Kanfer, Isadore.

Linked to FindBook

Google Book

Amazon

博客來

Bioequivalence requirements in various global jurisdictions

Record Type:	Electronic resources : Monograph/item
Title/Author:	Bioequivalence requirements in various global jurisdictions/ edited by Isadore Kanfer.
other author:	Kanfer, Isadore.
Published:	Cham :Springer Nature Switzerland : : 2025.,
Description:	xiii, 237 p. :ill. (chiefly color), digital ;24 cm.
[NT 15003449]:	Brazil -- Canada -- The European Union (EU) -- India -- Japan -- The United States of America -- World Health Organization (WHO).
Contained By:	Springer Nature eBook
Subject:	Drugs - Therapeutic equivalency. -
Online resource:	https://doi.org/10.1007/978-3-031-76774-6
ISBN:	9783031767746

Bioequivalence requirements in various global jurisdictions
Bioequivalence requirements in various global jurisdictions[electronic resource] /edited by Isadore Kanfer. - Second edition. - Cham :Springer Nature Switzerland :2025. - xiii, 237 p. :ill. (chiefly color), digital ;24 cm. - AAPS advances in the pharmaceutical sciences series,v. 612210-738X ;. - AAPS advances in the pharmaceutical sciences series ;v. 61..

Brazil -- Canada -- The European Union (EU) -- India -- Japan -- The United States of America -- World Health Organization (WHO).

An important objective of Bioequivalence Requirements in Various Global Jurisdictions is to attempt to gather current and updated information, collated in a single source, regarding the various bioequivalence and related requirements to satisfy the regulatory requirements for the market approval of multi-source (generic) drug products in various global jurisdictions. In view of the dynamic nature of regulatory requirements which are usually regularly updated, updating these requirements to remain current is an important necessity to provide such information 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. The revised volume includes updated information based on recent guidances and guidelines from the respective regulatory agencies as well as important trends and descriptions relating to innovative approaches for bioequivalence assessment.

ISBN: 9783031767746

Standard No.: 10.1007/978-3-031-76774-6doiSubjects--Topical Terms:

1359613
Drugs
--Therapeutic equivalency.

LC Class. No.: RM301.45

Dewey Class. No.: 615.1

Bioequivalence requirements in various global jurisdictions
LDR:02290nmm a2200349 a 4500 001 2409628
003 DE-He213
005 20250430130221.0
006 m d
007 cr nn 008maaau
008 260204s2025 sz s 0 eng d
020 $a 9783031767746 $q (electronic bk.)
020 $a 9783031767739 $q (paper)
024 7 $a 10.1007/978-3-031-76774-6 $2 doi
035 $a 978-3-031-76774-6
040 $a GP $c GP
041 0 $a eng
050 4 $a RM301.45
072 7 $a PSB $2 bicssc
072 7 $a SCI013040 $2 bisacsh
072 7 $a PNB $2 thema
082 0 4 $a 615.1 $2 23
090 $a RM301.45 $b .B615 2025
245 0 0 $a Bioequivalence requirements in various global jurisdictions $h [electronic resource] / $c edited by Isadore Kanfer.
250 $a Second edition.
260 $a Cham : $b Springer Nature Switzerland : $b Imprint: Springer, $c 2025.
300 $a xiii, 237 p. : $b ill. (chiefly color), digital ; $c 24 cm.
490 1 $a AAPS advances in the pharmaceutical sciences series, $x 2210-738X ; $v v. 61
505 0 $a Brazil -- Canada -- The European Union (EU) -- India -- Japan -- The United States of America -- World Health Organization (WHO).
520 $a An important objective of Bioequivalence Requirements in Various Global Jurisdictions is to attempt to gather current and updated information, collated in a single source, regarding the various bioequivalence and related requirements to satisfy the regulatory requirements for the market approval of multi-source (generic) drug products in various global jurisdictions. In view of the dynamic nature of regulatory requirements which are usually regularly updated, updating these requirements to remain current is an important necessity to provide such information 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. The revised volume includes updated information based on recent guidances and guidelines from the respective regulatory agencies as well as important trends and descriptions relating to innovative approaches for bioequivalence assessment.
650 0 $a Drugs $x Therapeutic equivalency. $3 1359613
650 1 4 $a Pharmaceutics. $3 3538434
650 2 4 $a Drug Safety and Pharmacovigilance. $3 2108855
650 2 4 $a Pharmacology. $3 634543
700 1 $a Kanfer, Isadore. $3 916535
710 2 $a SpringerLink (Online service) $3 836513
773 0 $t Springer Nature eBook
830 0 $a AAPS advances in the pharmaceutical sciences series ; $v v. 61. $3 3782929
856 4 0 $u https://doi.org/10.1007/978-3-031-76774-6
950 $a Chemistry and Materials Science (SpringerNature-11644)