Publications by authors named "L Korsholm"
Article Synopsis
- * In healthy cells, the homologous recombination (HR) process for rDNA stability is similar to that in other parts of the genome but is disrupted in BLM-deficient cells.
- * Without Bloom helicase (BLM), rDNA can still attract RAD51, which causes genomic instability and micronuclei formation, indicating broader implications for genome integrity.
A Risk-Based Assessment for Determining the Pharmacokinetic Comparability Requirements of Biologic-Device Combination Products Administered by Subcutaneous Injection.
AAPS J
September 2024
The development of new large molecule drug therapies along with the innovation of biologic-device combination products such as prefilled syringes, autoinjectors and pen injectors have significantly impacted the treatment of new diseases and has improved the process of administering parenteral medicines. To support the regulatory approval of a new biologic-device combination products or subsequent chemistry, manufacturing and control changes impacting a combination product, sponsor companies must thoroughly assess the potential impact to product quality, safety and efficacy. In this report, a risk-based process to determine the potential impact to product quality, safety, and efficacy as well as corresponding regulatory actions supporting a chemistry, manufacturing and control change is presented.
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- The study aimed to assess the effectiveness and safety of recombinant activated factor VIIa (rFVIIa) for treating severe postpartum hemorrhage (sPPH) through a multi-center randomized controlled trial and observational studies.
- In the RCT, a significantly lower percentage of women treated with rFVIIa required invasive procedures compared to those who did not receive the treatment, although this was not confirmed in the observational studies.
- Safety analysis revealed no increase in thromboembolic events for rFVIIa-treated women compared to non-treated women, indicating that while the efficacy may vary, the treatment is relatively safe.
Background: Assessment of homologous recombinant deficient (HRD) phenotypes is key for managing Poly (ADP-ribose) polymerase inhibitor (PARPi) treatment. To accommodate the need for a validated HRD platform and enhance targeted treatment of ovarian cancer patients, a Nordic core facility for the myChoice® CDx platform was established in Denmark.
Materials And Methods: Comparative calculations and statistics are based on information from test requisitions and results (Genome Instability Score [GIS], BRCA status and combined HRD status) obtained from ovarian and breast cancer samples submitted for HRD-testing by myChoice® CDx through the Nordic core facility in the 2-year period.
Purpose: To meet the urgent need for accessible homologous recombination-deficient (HRD) test options, we validated a laboratory-developed test (LDT) and a functional RAD51 assay to assess patients with ovarian cancer and predict the clinical benefit of poly(ADP-ribose) polymerase inhibitor therapy.
Methods: Optimization of the LDT cutoff and validation on the basis of samples from 91 patients enrolled in the ENGOT-ov24/NSGO-AVANOVA1&2 trial (ClinicalTrials.gov identifier: NCT02354131), previously subjected to commercial CDx HRD testing (CDx).