Clinical Pharmacology Review of Plasma‐derived and Recombinant Protein Products: CBER Experience and Perspectives on Model‐Informed Drug Development-Reference-Cited by-同舟云学术

Clinical Pharmacology Review of Plasma‐derived and Recombinant Protein Products: CBER Experience and Perspectives on Model‐Informed Drug Development

Published:2019-05-26 Issue: Volume: Page:
ISSN:1351-8216
Container-title:Haemophilia
language:en
Short-container-title:Haemophilia

Author:

Tegenge Million A.¹^ORCID,Mahmood Iftekhar²^ORCID,Forshee Richard¹

Affiliation:

1. Office of Biostatistics & Epidemiology Center for Biologics Evaluation and Research, Food & Drug Administration Silver Spring Maryland

2. Division of Clinical Evaluation and Pharmacology/Toxicology Office of Tissue and Advanced Therapies (OTAT) Center for Biologics Evaluation and Research, Food & Drug Administration Silver Spring Maryland

Publisher

Wiley

Subject

Genetics(clinical),Hematology,General Medicine

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1111/hae.13767

Reference32 articles.

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3. The history of clotting factor concentrates pharmacokinetics;Morfini M;J Clin Med,2017

4. Population pharmacokinetics of recombinant factor VIII: the relationships of pharmacokinetics to age and body weight;Bjorkman S;Blood,2012

5. Estimating and interpreting the pharmacokinetic profiles of individual patients with hemophilia A or B using a population pharmacokinetic approach: communication from the SSC of the ISTH;Iorio A;J Thromb Haemost,2017

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