ReviewBritish journal of clinical pharmacology2009
The use of gastrointestinal intubation studies for controlled release development.
Review in British journal of clinical pharmacology, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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
5 citing papers in PubMed, 1 synthesis or guideline pooled it, 18 citations in OpenAlex.
- Population Pharmacokinetics of Sertraline in Healthy Subjects: a Model-Based Meta-analysis.The AAPS journal · 2020Pooled it
- Formulation and Evaluation of Self-Nanoemulsifying Drug Delivery System Derived Tablet Containing Sertraline.Pharmaceutics · 2022Article
- Application of physiologically based pharmacokinetic modeling for sertraline dosing recommendations in pregnancy.NPJ systems biology and applications · 2020Article
- A semi-mechanistic modeling strategy for characterization of regional absorption properties and prospective prediction of plasma concentrations following administration of new modified release formulations.Pharmaceutical research · 2012Article
- Interdisciplinary science and the design of a single-dose antibiotic therapy.Pharmaceutical research · 2011Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
1 author at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
aimsThis review describes clinical results of gastrointestinal intubation studies of eight controlled release (CR) candidates under development during the 1990s and offers suggestions for determining why, when and how to conduct human intubation studies.
methodsExperience with the administration of the following eight compounds to various regions of the gastrointestinal tract is described: CJ-13,610, CP-195,543, CP-331,684, CP-409,092, CP-424,391, azithromycin, sertraline, and trovafloxacin. Also included are human pharmacokinetic studies with prototype CR dosage forms for CJ-13,610 and CP-424,391.
resultsIntubation studies, while appearing invasive, are safe and not unpleasant procedures that have been found to be valuable in the development of CR formulations.
conclusionsThe following recommendations are made regarding intubation studies: (i) no intubation study is recommended for compounds with high permeability, since these compounds are likely to be well absorbed from the colon; (ii) compounds with moderate permeability may require an intubation study if the dog colon and in silico models predict a marginally acceptable CR concentration-time profile; (iii) use a dose that approximates 1 h of the intended CR delivery rate; (iv) use the smallest volume possible; (v) define and record tubing placement; (vi) use a thermodynamically stable solution or/and suspension.
Indexed as
Identifiers
What 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.