ReviewPharmaceutical research2011
Using partial area for evaluation of bioavailability and bioequivalence.
Review in Pharmaceutical research, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 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.
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Who cites it
10 citing papers in PubMed.
- The Finite Absorption Time Concept Guiding Model Informed Drug & Generics Development in Clinical Pharmacology.Pharmaceutical research · 2025Review
- The First Physiologically Based Pharmacokinetic (PBPK) Model for an Oral Vaccine Using Alpha-Tocopherol as an Adjuvant.Pharmaceutics · 2023Article
- Re-examining digoxin bioavailability after half a century: Time for changes in the bioavailability concepts.Pharmaceutical research · 2021Article
- Revising Pharmacokinetics of Oral Drug Absorption: II Bioavailability-Bioequivalence Considerations.Pharmaceutical research · 2021Article
- Article
- Proposing the Use of Partial AUC as an Adjunctive Measure in Establishing Bioequivalence Between Deltoid and Gluteal Administration of Long-Acting Injectable Antipsychotics.European journal of drug metabolism and pharmacokinetics · 2016Article
- The clinical impact of switching attention deficit hyperactivity disorder patients from OROS(®)-MPH to Novo-MPH ER-C(®): A paediatric practice review.Paediatrics & child health · 2013Article
- Use of partial AUC (PAUC) to evaluate bioequivalence--a case study with complex absorption: methylphenidate.Pharmaceutical research · 2013Article
- Metrics for the evaluation of bioequivalence of modified-release formulations.The AAPS journal · 2012Review
- Use of partial area under the curve metrics to assess bioequivalence of methylphenidate multiphasic modified release formulations.The AAPS journal · 2012Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Assessment of bioavailability/bioequivalence generally relies on the comparison of rate and extent of drug absorption between products. Rate of absorption is commonly expressed by peak concentration (C(max)) and time to peak concentration (T(max)), although these parameters are indirect measures of absorption rate. Recognizing the importance of systemic exposure to drug efficacy and safety, FDA recommended that systemic exposure be better used for bioavailability/bioequivalence assessment. Apart from peak exposure and total exposure, FDA also recommended a new metric for early exposure that is considered necessary when a control of input rate is critical to ascertain drug efficacy and/or safety profile. The early exposure can be measured by truncating the area under the curve at T(max) of the reference product (PAUC(r,tmax)) or some designated early time after dosing. The choice of truncation is most appropriately based on PK/PD relationship or efficacy/safety data for the drug under examination. Compared with C(max), PAUC(r,tmax) has higher sensitivity in detecting formulation differences and may be more variable. If the metric is highly variable, the reference-scaling approach can be employed for bioequivalence evaluation. The partial area metric is useful in PK/PD characterization as well as in the evaluation of bioavailability, bioequivalence and/or comparability.
Indexed as
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21487930What 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.