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Bioequivalence Requirements in Various Global Jurisdictions

door Isadore Kanfer - Verkocht door Dodax EU
Staat: Nieuw
€ 169,87
Incl. BTW - Gratis verzenden
Isadore Kanfer Bioequivalence Requirements in Various Global Jurisdictions
Isadore Kanfer - Bioequivalence Requirements in Various Global Jurisdictions

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Levering: tussen 2020-12-08 en 2020-12-10
Verkoop en verzending: Dodax EU

Beschrijving

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.

Medewerkers

Uitgever Isadore Kanfer

Productdetails

DUIN 12JM7UVSD1H

GTIN 9783319680774

Verschijningsdatum 21.12.2017

Taal Engels

Pagina-aantallen 345

Product type Boek

Maat 235 x 158 x 155  mm

Gewicht van product 6565 g

€ 169,87
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