Population-Based Mechanistic Prediction of Oral Drug Absorption
Open accessAbstract
The bioavailability of drugs from oral formulations is influenced by many physiological factors including gastrointestinal fluid composition, pH and dynamics, transit and motility, and metabolism and transport, each of which may vary with age, gender, race, food, and disease. Therefore, oral bioavailability, particularly of poorly soluble and/or poorly permeable compounds and those that are extensively metabolized, often exhibits a high degree of inter- and intra-individual variability. While several models and algorithms have been developed to predict bioavailability in an average person, efforts to accommodate intrinsic variability in the component processes are less common. An approach that incorporates such variability for human populations within a mechanistic framework is described together with examples of its application to drug and formulation development.
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Simcyp provides a variety of options for the input of absorption parameters including several built-in correlation methods to scale in vitro measured values and the SIVA toolkit, whereas these methods are not present in PK-Sim.
“In general, Simcyp provides a variety of options (alternative to user defined/estimated) for the input of absorption parameters including several built‐in correlation methods to scale in vitro measured values as well as the Simcyp In Vitro data Analysis (SIVA) toolkit, 40 whereas in PK‐Sim, these methods are not present.”
From Does the choice of applied physiologically‐based pharmacokinetics platform matter? A case study on simvastatin disposition and drug–drug interaction (2022) · cites this paper as [40]
In Simcyp, different models for absorption with a wide range of complexity are available.
“In Simcyp, different models for absorption with a wide range of complexity are available. 40”
From Does the choice of applied physiologically‐based pharmacokinetics platform matter? A case study on simvastatin disposition and drug–drug interaction (2022) · cites this paper as [40]
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- Authors
- Jamei, M., Turner, D., Yang, J., Neuhoff, S., Polak, S., Rostami-Hodjegan, A., & Tucker, G.
- Affiliations
- Simcyp (United Kingdom) (GB)
- Corresponding author
- Jamei, Masoud
- Venue
- The AAPS Journal
- Published
- 2009-04-21
- Volume
- 11
- Issue
- 2
- Pages
- 225-237
- ISSN
- 1550-7416 (ISSN-L)
- PMC
- PMC2691459
- OpenAlex
- W2006967678
- Cited by
- 452
- References
- 3
- Citations by year
- 2026: 21 · 2025: 40 · 2024: 21 · 2023: 24 · 2022: 33 · 2021: 36 · 2020: 23 · 2019: 25 · 2018: 31 · 2017: 24 · 2016: 31 · 2015: 26 · 2014: 29 · 2013: 25 · 2012: 26
- FWCI
- 2.15
- Type
- journal article
- Language
- en
- Open access
- green
- www.ncbi.nlm.nih.gov
- Licence
- www.springer.com/tdm (tdm)
- Locations
- The AAPS Journal (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- Research Explorer (The University of Manchester) (submittedVersion)
- Topics
- Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Pharmaceutical Science › Drug Solubulity and Delivery Systems
- Health Sciences › Medicine › Pediatrics, Perinatology and Child Health › Pharmaceutical studies and practices
- Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Pharmacology › Pharmacogenetics and Drug Metabolism
- Keywords
- oral drug absorption, bioavailability prediction, population pharmacokinetics, mechanistic modeling, interindividual variability, within-person variability, digestive physiology, drug solubility, drug permeability, food effect, drug formulation development
- MeSH terms
- Animals, Biological Availability, Biotransformation, Chemistry, Pharmaceutical, Pharmaceutical Preparations, Forecasting, Humans, Intestinal Absorption, Pharmacokinetics, Population, Solubility
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