Extrapolation and dosing recommendations for raxibacumab in children from birth to age <18 years

Author:

Oosterholt Sean P.1ORCID,Della Pasqua Oscar12ORCID

Affiliation:

1. Clinical Pharmacology & Therapeutics Group University College London UK

2. Clinical Pharmacology Modelling and Simulation, GlaxoSmithKline Brentford UK

Funder

GlaxoSmithKline foundation

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Reference31 articles.

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2. Code of Federal Regulations.Approval of biological products when human efficacy studies are not ethical or feasible. Title 21 Food and Drug Administration 2002. Available at:https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=601&showFR=1&subpartNode=21:7.0.1.1.2.8. Last accessed on May 11 2020.

3. Food and Drug Administration.CDER DRUG AND BIOLOGIC ANIMAL RULE APPROVALS.2018. Available at:https://www.fda.gov/media/107839/download. Last accessed on May 11 2020.

4. A Phase 1 Study of PAmAb, a Fully Human Monoclonal Antibody against Bacillus anthracis Protective Antigen, in Healthy Volunteers

5. What is the right dose for children?

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