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Titlebook: Bioequivalence Requirements in Various Global Jurisdictions; Isadore Kanfer Book 2017 American Association of Pharmaceutical Scientists 20

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The European Union,ribution than in the past 5 years, and no single year will reach the level seen in 2012. Generic medicines will continue to provide the vast majority of the prescription medicines use in the US, rising from 88% to over 90% of all dispensed prescriptions by 2020 [2].
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Russia, Belarus & Kazakhstan,ection with this Agreement which contains an approach to prepare a unified guidance for BE studies, a plan for document preparation has been approved (a Custom Union BE guidance was approved in May 2017).
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World Health Organisation (WHO), enjoy political support for the regulators, or have properly resourced and functioning regulatory authorities [2]. It is no wonder that in many resource-poor settings patients do not trust locally authorized multisource (generic) products.
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Japan, These figures pale in comparison with countries such as the United States, Germany, and the United Kingdom where generic drug product penetration levels are far more than half of the total pharmaceutical products volume.
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