ArticleCPT: pharmacometrics & systems pharmacology2016
Good Practices in Model-Informed Drug Discovery and Development: Practice, Application, and Documentation.
Article in CPT: pharmacometrics & systems pharmacology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 186 papers, 5 of them syntheses that pooled it.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
186 citing papers in PubMed, 5 syntheses or guidelines pooled it.
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- Skipping a pillar does not make for strong foundations: Pharmacokinetic-pharmacodynamic reasoning behind the shape of dose-response relationships in oncology.CPT: pharmacometrics & systems pharmacology · 2023Pooled it
- A Systematic Review of the Efforts and Hindrances of Modeling and Simulation of CAR T-cell Therapy.The AAPS journal · 2021Pooled it
- Structural identifiability for mathematical pharmacology: models of myelosuppression.Journal of pharmacokinetics and pharmacodynamics · 2018Pooled it
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- Bioavailability of three novel oral, sustained-release pellets, relative to an immediate-release tablet containing 500 mg flucytosine: A randomized, open-label, crossover study in healthy volunteers.Clinical and translational science · 2024Trial
- Quantitative Clinical Pharmacology Supports the Bridging From i.v. Dosing and Approval of s.c. Rituximab in B-Cell Hematological Malignancies.Clinical pharmacology and therapeutics · 2021Trial
- Translational and pharmacokinetic-pharmacodynamic application for the clinical development of GDC-0334, a novel TRPA1 inhibitor.Clinical and translational science · 2021Trial
- How Semiphysiological Population Pharmacokinetic Modeling Incorporating Active Hepatic Uptake Supports Phase II Dose Selection of RO7049389, A Novel Anti-Hepatitis B Virus Drug.Clinical pharmacology and therapeutics · 2021Trial
- An Innovative Pharmacometric Approach for the Simultaneous Analysis of Frequency, Duration and Severity of Migraine Events.Pharmaceutical research · 2020Trial
- Assessing Similarity Among Individual Tumor Size Lesion Dynamics: The CICIL Methodology.CPT: pharmacometrics & systems pharmacology · 2018Trial
- Overview of Regulatory Guidelines Related to Methods and Models for Small Populations.Clinical pharmacology and therapeutics · 2026Review
- Pharmaceutical Industry Perspectives on Exposure-Response Confounding in Large Molecule Therapeutics: Results From an IQ Consortium Survey.CPT: pharmacometrics & systems pharmacology · 2026Article
- The 95% CDIRAs, a Credible Interval Based Method to Capture Uncertainty in Population Modeling: Pharmacokinetics Versus Sum of Exponentials Case Study.CPT: pharmacometrics & systems pharmacology · 2026Article
- From Classical PKPD to Model-Informed Drug Development: Are "Digital Twins" a New Paradigm?Clinical pharmacology and therapeutics · 2026Article
- Physiologically Based Pharmacokinetic Modeling to Predict Human Starting Dose and Pharmacokinetics for Rocbrutinib.Clinical and translational science · 2026Article
- Population Pharmacokinetic Comparability of CT-P16 Versus EU-AvastinBioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2026Article
- Mechanism-Based Pharmacokinetic and Pharmacodynamic Modeling.Pharmaceutics · 2026Article
126 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
19 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
This document was developed to enable greater consistency in the practice, application, and documentation of Model-Informed Drug Discovery and Development (MID3) across the pharmaceutical industry. A collection of "good practice" recommendations are assembled here in order to minimize the heterogeneity in both the quality and content of MID3 implementation and documentation. The three major objectives of this white paper are to: i) inform company decision makers how the strategic integration of MID3 can benefit R&D efficiency; ii) provide MID3 analysts with sufficient material to enhance the planning, rigor, and consistency of the application of MID3; and iii) provide regulatory authorities with substrate to develop MID3 related and/or MID3 enabled guidelines.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.