Assessment of the Anticoagulation Activity of Apixaban

Gonçalves, Luís Moreira; Araújo, Fernando

doi:10.1253/circj.cj-15-0399

Circ J

2015

DOI: 10.1253/circj.cj-15-0399

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Assessment of the Anticoagulation Activity of Apixaban

Luís Moreira Gonçalves

Fernando Araújo

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2024

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An Investigation in the Comparability of the Exposure and Recommended Dose of Selected Pfizer Drugs in East Asian Countries: Is Mutual Usage of Clinical Data Among East Asian Countries Feasible?

Wang,

Yu,

Fukuhara

et al. 2024

The Journal of Clinical Pharma

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Current regulatory path for new drug registration in East Asian countries has led to significant delay of the new medicines in these countries. A unified regulatory path and allowance of mutual usage of clinical data in East Asian countries would lead to cost‐saving in drug development and expedite the new drug registration in these countries. The objectives of the present analyses are to compare the approval dates of a selection of products developed by Pfizer in US and East Asian countries (China, Japan, Korea), and compare the PK and recommended dose of these products in East Asian countries. Eighteen (18) products (20 drugs, 2 products with 2 combination drugs) with exposure data available in at least 2 of the 3 East Asian countries across different therapeutic areas were included in the analyses. The results showed that most products had delayed approval in East Asian countries (up to 8 years) post US or EU approval. No distinct differences were observed in the drug exposure and recommended doses for the selected products in East Asian countries. These results together with literature data of genetic similarity of the East Asian populations support the mutual usage of the clinical data in the East Asian countries for expedited regulatory submission and approval.This article is protected by copyright. All rights reserved

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An Investigation in the Comparability of the Exposure and Recommended Dose of Selected Pfizer Drugs in East Asian Countries: Is Mutual Usage of Clinical Data Among East Asian Countries Feasible?

Wang,

Yu,

Fukuhara

et al. 2024

The Journal of Clinical Pharma

View full text Add to dashboard Cite

show abstract

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Assessment of the Anticoagulation Activity of Apixaban

Cited by 1 publication

References 4 publications

An Investigation in the Comparability of the Exposure and Recommended Dose of Selected Pfizer Drugs in East Asian Countries: Is Mutual Usage of Clinical Data Among East Asian Countries Feasible?

An Investigation in the Comparability of the Exposure and Recommended Dose of Selected Pfizer Drugs in East Asian Countries: Is Mutual Usage of Clinical Data Among East Asian Countries Feasible?

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