Post‐marketing dosing changes in the label of biologicals-Reference-Cited by-同舟云学术

Post‐marketing dosing changes in the label of biologicals

Published:2019-02-16 Issue:4 Volume:85 Page:715-721
ISSN:0306-5251
Container-title:British Journal of Clinical Pharmacology
language:en
Short-container-title:Br J Clin Pharmacol

Author:

Minnema Lotte A.¹²^ORCID,Giezen Thijs J.²³,Gardarsdottir Helga¹⁴,Egberts Toine C. G.¹⁴,Leufkens Hubert G. M.¹,Mantel‐Teeuwisse Aukje K.¹

Affiliation:

1. Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences (UIPS)Utrecht University Utrecht The Netherlands

2. Medicines Evaluation Board Utrecht The Netherlands

3. Foundation Pharmacy for Hospitals in Haarlem Haarlem The Netherlands

4. Department of Clinical PharmacyUniversity Medical Centre Utrecht Utrecht The Netherlands

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1111/bcp.13843

Reference26 articles.

1. Challenges of general safety evaluations of biologics compared to small molecule pharmaceuticals in animal models

2. Applicability of predictive toxicology methods for monoclonal antibody therapeutics: status quo and scope;Kizhedath A;Arch Toxicol,2016

3. Immunogenicity of mAbs in non-human primates during nonclinical safety assessment

4. Postmarketing drug dosage changes of 499 FDA-approved new molecular entities, 1980-1999

5. Changes and determination of dosing recommendations for medicinal products recently authorised in the European Union

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