Pharmacokinetic Profiles for Oral and Subcutaneous Methotrexate in Patients with Crohnʼs Disease
Bibliographic record
Abstract
Purpose: Methotrexate (MTX) is administered subcutaneously to Crohn's disease (CD) patients. There are very few studies evaluating the use of oral (PO) MTX in CD. A drug and its pharmaceutical alternative are equivalent (bioequivalence) when the bioavailability of the alternative falls within 80-125% of the bioavailability of the standard (U.S. Food and Drug Administration - FDA). The aim of this pharmacokinetic (Pk) study was to compare the Pk profiles of PO and subcutaneous (SC) MTX in Crohn's disease patients to determine the bioequivalence of these two routes. Methods: Eight patients received a PO and an SC MTX dose (25 mg) separated by one week over a two week interval. Blood samples were collected at specified times over a 24-hour period for each patient on two separate days. MTX plasma levels were obtained using a sensitive mass spectrometer. Areas under the curve (AUC) were compared between the two routes. Results: The arithmetic mean AUC values (95% confidence intervals) were 2763 ng/ml x hr (PO MTX) and 3211 ng/ml x hr (SC MTX) (p < 0.01). The mean AUC ratio (PO/SC) was 0.86 (0.77-1.08). This correlates with a relative PO bioavailability of 86% in comparison to SC. There were no adverse events. Conclusion: The mean relative bioavailability (PO/SC AUC ratio) in these 8 patients meets the established criteria set by the FDA for bioequivalence. This study suggests that even though there is a statistically significant difference between the bioavailability of PO and SC MTX, clinically, these routes are bioequivalent.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.000 | 0.003 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.000 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.001 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".