Equivalence of Liquid and Freeze-Dried Formulations of WinRho® SDF.
Bibliographic record
Abstract
Abstract WinRho® SDF is licensed in the USA, Canada and Europe to treat ITP and prevent Rh isoimmunization. Although safe, efficacious and cost-effective, WinRho® SDF has only been available in a freeze-dried formulation. In order to simplify injection preparation and reduce the possibility of preparation errors, a liquid formulation of WinRho® SDF has been developed. The pharmacokinetics and tolerability of the liquid and freeze-dried preparations were compared in 2 randomized, double-blind, multi-center phase 1 studies that were conducted in healthy adult volunteers. Subjects were administered one of the formulations either IM (300 μg or 15 μg/kg) or IV (50 μg/kg). Pharmacokinetics (AUC, Cmax, t1/2, tmax) and safety data (adverse events and laboratory assessments) were assessed over 84 days. In total, 142 subjects received either the liquid or freeze-dried formulations (N=71 each group). Following IV or IM administration, the ratios (90% confidence intervals) for AUC and Cmax were within the FDA required acceptance range of 80–125% to demonstrate bioequivalence. Both formulations had comparable half-lifes of ~18–19 days and ~26 days following IV or IM administration, respectively. While tmax occurred immediately following IV administration, tmax was ~3–7 days after IM administration. Both formulations were similarly tolerated following either IV or IM administration. The most common adverse events were headaches and neck/back pain. Liquid WinRho® SDF was demonstrated to be bioequivalent to the freeze-dried formulation following IV or IM administration. This suggests that liquid WinRho® SDF may be therapeutically equivalent to the freeze-dried formulation and provide a more convenient presentation for use.
Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.
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) | 0.000 | 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 | 0.001 |
| Insufficient payload (model declined to judge) | 0.002 | 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".