ArticleEuropean journal of drug metabolism and pharmacokinetics2021
Pharmacokinetic Modeling and Predictive Performance: Practical Considerations for Therapeutic Monoclonal Antibodies.
Article in European journal of drug metabolism and pharmacokinetics, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.
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Who cites it
2 citing papers in PubMed, 4 citations in OpenAlex.
- Advancing Precision Medicine: A Review of Innovative In Silico Approaches for Drug Development, Clinical Pharmacology and Personalized Healthcare.Pharmaceutics · 2024Review
- Pharmacokinetics and Adverse Effects of Clofazimine in the Treatment of Pulmonary Non-Tuberculous Mycobacterial Infection.Antimicrobial agents and chemotherapy · 2022Observational
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Authors and funding
4 authors at 2 institutions in 1 country.
Funding
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Abstract
Population pharmacokinetic (PopPK) model parameter estimation and predictive performance depend on the data adequacy for model building. PopPK models of therapeutic monoclonal antibodies (mAbs) may not be well supported by commonly used sparse sampling in late-stage development because of the slow absorption (days) and long half-life (weeks) of mAbs, affecting accuracy of predicted exposure metrics which are often used to support drug development. A case study was presented for a representative mAb to compare the predictive performance of two established PopPK models from their respective data. Differences in datasets for model building (including sample size, sampling schedule and route of administration), model structure and parameters, and key derived exposure metrics were compared, and the resulting differences in model prediction were elaborated. With the majority of the data used for developing models being trough concentration (C
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