A Comparative Parallel Study of Pharmacokinetics and Immunogenicity Following Single Intravenous Administration of Bevacizumab Biosimilar RPH-001 (Manufactured by R-Pharm Group, Russia) and Avastin® (Manufactured by F. Hoffmann-La Roche Ltd., Switzerland) in Healthy Male Volunteers
Why this work is in the frame
A frame that forgets how it found something cannot be audited. These are the routes that admitted this work.
Bibliographic record
Abstract
Introduction. Bevacizumab is a monoclonal IgG1 antibody that binds to and inhibits the biologic activity of human vascular endothelial growth factor (VEGF). Bevacizumab is used as a targeted mono- or combination therapy for different solid tumors. Phase I clinical trial was performed to assess pharmacokinetics (PK) and immunogenicity of bevacizumab drugs. For this study 80 healthy male volunteers were recruited and randomized to either Avastin or RPH-001 group. Aim. To assess and compare pharmacokinetics and immunogenicity (safety) following single intravenous administration of Avastin® (manufactured by F. Hoffmann-La Roche Ltd.,Switzerland) and bevacizumab biosimilar RPH-001 (manufactured by R-Pharm Group,Russia). Materials and methods. Bevacizumab quantitation and quasi-quantitative anti-bevacizumab antibodies detection in human blood serum were carried out using photometric ELISA. Two different methods were successfully validated. Results and discussion. Bevacizumab quantitation method was validated for selectivity and specificity, calibration curve, sensitivity, accuracy and precision, minimal required dilution, dilution linearity and stability. The anti-bevacizumab antibodies detection method was validated for cut-point (with normalization factor calculation), selectivity, sensitivity, precision, drug tolerance, dilution linearity, matrix effect (in case of serum hemolysis), and stability. The validated methods were successfully applied to pharmacokinetic and immunogenicity assessment of bevacizumab drugs. Conclusion. The results of the PK-study showed that test and reference bevacizumab drugs were equivalent. Immunogenicity study did not show any evidence of anti-bevacizumab antibodies in blood serum samples.
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.
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.001 | 0.000 |
| 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) | 0.000 | 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 it