Bibliographic record
Abstract
Neoral absorption profiling is a concept in therapeutic drug monitoring (TDM) designed to further optimize the clinical benefits of Neoral (cyclosporin) in transplant patients without a significant increase in workload commitment to patient management.Neoral absorption profiling is a cyclosporine (CyA) monitoring strategy that unites several advanced methods that utilized markers of the absorption phase of Neoral to optimize dosing in the individual patient.This absorption phase -which typically occurs during the first 4 hours following Neoral administration -provides markers that are much more accurate predictors of drug exposure, and consequently of clinical response, than the standard trough-level measurement.The Neoral Absorption Profiling concept is not associated with any specific monitoring protocol, but is an umbrella term for the clinically tested protocols that use surrogate markers of the absorption phase of Neoral.A single blood-level measurement made 2 hours after dosing (C-2) has been shown in liver transplant patients to be a significantly more accurate predictor of drug exposure than trough levels, and its use results in a reduction in the incidence and severity of cellular rejection.In long term liver transplant recipients, adoption of C2 monitoring defines patients both over and under dosed which is not distinguished by CO (trough) measurements.Adjustments of C2 levels to recommended targets even at 5-10 years post -transplant results in improvement in nephrotoxicity as measured by serum creatinine without exposing the patient to the risk of rejection.In renal transplant recipients, utilizing parameters that measure this absorption phase (AUCO-4) resulted in a low incidence of acute cellula rejection and excellent graft and patient outcomes.Patients whose AUCO-4 during week one post transplant fell within the range of 4400-5500ng/mL had an incidence of acute cellular rejection of 6%.In contrast CO (Cmin) values correlated poorly with both AUCO-4 and the incidence of acute cellular rejection.In a prospective trial in de novo renal transplant recipients, those patients receiving Neoral who achieved target levels of 4400-5500ng/mL within 5days had an incidence of acute cellular rejection of 7% at 6 months post transplant.Compared with an incidence of 37% in those patients who did not achieve this target within 5days demonstrating the importance of reaching target early.Furthermore, in those patients who achieved target early the serum creatinine at 6 months was 127 umole/L compared to 172 umole/L in patients who did not achieve target early.Of single sample points, C2 correlates best with AUCO-4 throughout the study range (r2=0.86);CO had the poorest correlation.In an international study in 21 centers examining absorption profiling, two hour post dose (C2) samples were the most accurate single predictor of AUCO-4 and defined absorption status of patients, identifying those who need more aggressive dosing to achieve target levels.In summary, despite a level of simplicity comparable to trough-level measurement, Neoral Absorption Profiling is a much more sensitive approach to assessing the pharmacokinetics and predicting the clinical impact of Neoral in the individual patient.By adopting this new approach, the clinician is able to tailor the dose of Neoral more accurately to the needs of the individual patient and can expect to see an improvement in outcomes.
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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 | 0.001 | 0.001 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.000 |
| Bibliometrics | 0.001 | 0.000 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.002 | 0.002 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.011 | 0.003 |
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".