Trial reportPharmaceutical research2010
Population in vitro-in vivo correlation model for pramipexole slow-release oral formulations.
Trial report in Pharmaceutical research, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
6 citing papers in PubMed.
- Population pharmacokinetics of tenofovir alafenamide delivered via an annual subdermal implant in South African women.Scientific reports · 2026Trial
- A semi-mechanistic modeling strategy to link in vitro and in vivo drug release for modified release formulations.Pharmaceutical research · 2012Trial
- Statistical comparison of dissolution profiles to predict the bioequivalence of extended release formulations.The AAPS journal · 2014Article
- A new approach to dissolution testing by UV imaging and finite element simulations.Pharmaceutical research · 2013Article
- Once-daily pramipexole for the treatment of early and advanced idiopathic Parkinson's disease: implications for patients.Neuropsychiatric disease and treatment · 2011Article
- Real-time UV imaging of nicotine release from transdermal patch.Pharmaceutical research · 2010Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeTo establish an in vitro-in vivo level A correlation (IVIVC) for pramipexole slow-release formulations.
methodsThe IVIVC was developed based on data from an immediate-release (IR) and three slow-release (SR) formulations of pramipexole; a fourth SR formulation was used for validation purposes. In vitro dissolution profiles were obtained from all SR formulations. Fifteen volunteers received all pramipexole formulations in a randomized cross-over trial. Data were analyzed using the population modelling approach as implemented in NONMEM VI.
resultsDissolution profiles of the SR formulations were described by the Weibull model. The pharmacokinetics of the IR formulation were described by a two-compartment disposition model with first-order absorption. Difference between the in vivo and in vitro estimates of the release rate constants (k(d)) from the Weibull function suggests the release process occurs faster in vivo. Pharmacokinetic profiles for SR formulations were described based on the in vitro release model with k(d) increased in 0.058 h(-1) and the population pharmacokinetic model developed from the IR formulation.
conclusionA level A IVIVC was established and evaluated for the pramipexole SR formulations, which can be used in the future as a surrogate to avoid certain bioequivalence studies.
Indexed as
Identifiers
20039105What OpenQuestion holds
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.