Getting Innovative Therapies Faster to Patients at the Right Dose: Impact of Quantitative Pharmacology Towards First Registration and Expanding Therapeutic Use
Open accessAbstract
Quantitative pharmacology (QP) applications in translational medicine, drug‐development, and therapeutic use were crowd‐sourced by the ASCPT Impact and Influence initiative. Highlighted QP case studies demonstrated faster access to innovative therapies for patients through 1) rational dose selection for pivotal trials; 2) reduced trial‐burden for vulnerable populations; or 3) simplified posology. Critical success factors were proactive stakeholder engagement, alignment on the value of model‐informed approaches, and utilizing foundational clinical pharmacology understanding of the therapy.
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The ASCPT Quantitative Pharmacology Network provides case studies of modeling impact, including the key question addressed, impact on decision making, and estimated time saving.
“The impact examples collected by the American Society for Clinical Pharmacology and Therapeutics (ASCPT) Quantitative Pharmacology Network84 provide a number of case studies, including the key question that needed to be addressed, impact on decision making, and estimated time saving.”
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References 9 · Cited by 23
Research works printed but not linked: 4
- [1]Zhang, L. et al Model‐based drug development: the road to quantitative pharmacology. J. Pharmacokinet. Pharmacodyn. 33, 369– 393 (2006). 16770528
- [3]Milligan, P.A., Brown, M.J., Marchant, B., Martin, S.W., van der Graaf, P.H. & Benson, N. Model‐based drug development: a rational approach to efficiently accelerate drug development. Clin. Pharmacol. Ther. 93, 502– 514 (2013). 23588322
- [4]Allerheiligen, S.R. Impact of modeling and simulation: myth or fact? Clin. Pharmacol. Ther. 96, 413– 415 (2014). 25236663
- [5]Visser, S.A., Norton, J., Marshall, S. & O'Kelly, M. Common best practice in modeling & simulation across quantitative disciplines: a comparison of independently emerging proposals. Stat. Biopharm. Res. doi: 10.1080/19466315.2017.1385520 (2017) [Epub ahead of print]. · DOI
- Authors
- Nayak, S., Sander, O., Al‐Huniti, N., de Alwis, D., Chain, A., Chenel, M., Sunkaraneni, S., Agrawal, S., Gupta, N., & Visser, S. A. G.
- Affiliations
- Pfizer (United States) (US)
- Novartis (Switzerland) (CH)
- Quantitative Clinical Pharmacology AstraZeneca Waltham Massachusetts USA
- MSD Rahway New Jersey USA
- Merck & Co., Inc., Rahway, NJ, USA (United States) (US)
- Servier, Clinical Pharmacokinetics and Pharmacometrics Suresnes France
- Sunovion (United States) (US)
- Bristol-Myers Squibb (United States) (US)
- Takeda Oncology (United States) (US)
- GlaxoSmithKline (United States) (US)
- Corresponding author
- Visser, Sandra A.G.
- Venue
- Clinical Pharmacology & Therapeutics
- Publisher
- Wiley
- Published
- 2018-01-13
- Volume
- 103
- Issue
- 3
- Pages
- 378-383
- ISSN
- 0009-9236 (ISSN-L)
- 1532-6535
- PMC
- PMC5838712
- OpenAlex
- W2783424399
- Cited by
- 23
- References
- 9
- Citations by year
- 2024: 1 · 2023: 2 · 2022: 2 · 2021: 6 · 2020: 2 · 2019: 7 · 2018: 3
- FWCI
- 4.97
- Type
- journal article
- Language
- en
- Update notices
- correction (2018-09-14)
- Open access
- hybrid
- doi.org
- Licence
- Locations
- Clinical Pharmacology & Therapeutics (publishedVersion, cc-by-nc-nd)
- Europe PMC (PubMed Central) (publishedVersion, cc-by-nc-nd)
- PubMed Central (publishedVersion, cc-by-nc-nd)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Pediatrics, Perinatology and Child Health › Pharmaceutical studies and practices
- Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
- Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Pharmacology › Pharmacogenetics and Drug Metabolism
- Keywords
- quantitative pharmacology, drug development, dose selection, regulatory approval, therapeutic applications, trial burden, vulnerable populations, stakeholder engagement, model-informed drug development, translational medicine
- MeSH terms
- Clinical Trials as Topic, Drug Therapy, Pharmaceutical Preparations, Humans, Pharmacology, Clinical, Research Design, Therapies, Investigational, Translational Research, Biomedical, Crowdsourcing
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