Allometric scaling of therapeutic monoclonal antibodies in preclinical and clinical settings

Author:

Germovsek Eva1ORCID,Cheng Ming2,Giragossian Craig3

Affiliation:

1. Translational Medicine and Clinical Pharmacology, Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany

2. Development Biologicals, Drug Metabolism And Pharmacokinetics, Boehringer Ingelheim Pharmaceuticals Inc, Ridgefield, US

3. Biotherapeutics Discovery, Boehringer Ingelheim Pharmaceuticals Inc, Ridgefield, US

Funder

assist the preparation of this review

Publisher

Informa UK Limited

Subject

Immunology,Immunology and Allergy

Reference163 articles.

1. Rational development and utilization of antibody-based therapeutic proteins in pediatrics

2. Antibodies to watch in 2020

3. U. S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER). General clinical pharmacology considerations for pediatric studies for drugs and biological products. Guidance for Industry, 2014. [accessed 02 June 2021]. Available from: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/general-clinical-pharmacology-considerations-pediatric-studies-drugs-and-biological-products

4. EMA Committee for Medicinal Products for Human Use (CHMP). Guideline on the role of pharmacokinetics in the development of medicinal products in the paediatric population. 2006. [accessed 02 June 2021]. Available from: https://www.ema.europa.eu/documents/scientific-guideline/guideline-role-pharmacokinetics-development-medicinal-products-paediatric-population_en.pdf

5. U. S. Food and Drug Administration, Department of Health and Human Services. Best Pharmaceuticals for Children Act and Pediatric Research Equity Act. Status Report to Congress, 2016. [accessed 30 Apr 2021]. Available from: https://www.fda.gov/science-research/pediatrics/best-pharmaceuticals-children-act-and-pediatric-research-equity-act

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