Clinical Pharmacology Applications of Real‐World Data and Real‐World Evidence in Drug Development and Approval–An Industry Perspective
Since the 21st Century Cures Act was signed into law in 2016, real‐world data (RWD) and
real‐world evidence (RWE) have attracted great interest from the healthcare ecosystem …
real‐world evidence (RWE) have attracted great interest from the healthcare ecosystem …
Advancing the utilization of real‐world data and real‐world evidence in clinical pharmacology and translational research—Proceedings from the ASCPT 2023 …
J Liu, K Rowland‐Yeo, A Winterstein… - Clinical and …, 2024 - Wiley Online Library
Real‐world data (RWD) and real‐world evidence (RWE) are now being routinely used in
epidemiology, clinical practice, and post‐approval regulatory decisions. Despite the …
epidemiology, clinical practice, and post‐approval regulatory decisions. Despite the …
[HTML][HTML] Complex PK-PD of an engineered IL-15/IL-15Rα–Fc fusion protein in cynomolgus monkeys: QSP modeling of lymphocyte dynamics
XmAb24306 is a lymphoproliferative interleukin (IL)-15/IL-15 receptor α (IL-15Rα) Fc-fusion
protein currently under clinical investigation as an immunotherapeutic agent for cancer …
protein currently under clinical investigation as an immunotherapeutic agent for cancer …
Clinical pharmacology strategies to accelerate the development of polatuzumab vedotin and summary of key findings
MZ Liao, D Lu, T Lu, L Gibiansky, R Deng… - Advanced Drug Delivery …, 2024 - Elsevier
The favorable benefit–risk profile of polatuzumab vedotin, as demonstrated in a pivotal
Phase Ib/II randomized study (GO29365; NCT02257567), coupled with the need for effective …
Phase Ib/II randomized study (GO29365; NCT02257567), coupled with the need for effective …
Real‐World Evidence Application in Translational Medicine: Making Use of Prescription Claims to Inform Drug–Drug Interactions of a New Psoriasis Treatment
CKC Choong, J Rehmel… - The Journal of Clinical …, 2024 - Wiley Online Library
Patients with psoriasis often take multiple medications due to comorbidities, raising
concerns about drug–drug interactions (DDIs) during the development of new medicines …
concerns about drug–drug interactions (DDIs) during the development of new medicines …
Integrated summary of immunogenicity of polatuzumab vedotin in patients with relapsed or refractory B-cell non-Hodgkin's lymphoma
Polatuzumab vedotin, marketed under the trade name POLIVY®, is a CD79b-targeted
antibody-drug conjugate that preferentially delivers a potent anti-mitotic agent (monomethyl …
antibody-drug conjugate that preferentially delivers a potent anti-mitotic agent (monomethyl …
gPKPDviz: A flexible R shiny tool for pharmacokinetic/pharmacodynamic simulations using mrgsolve
GPKPDviz is a Shiny application (app) dedicated to real‐time simulation, visualization, and
assessment of the pharmacokinetic/pharmacodynamic (PK/PD) models. Within the app …
assessment of the pharmacokinetic/pharmacodynamic (PK/PD) models. Within the app …
Ethnic sensitivity assessment: Polatuzumab vedotin pharmacokinetics in Asian and non‐Asian patients with previously untreated diffuse large B‐cell lymphoma in …
MZ Liao, R Deng, L Gibiansky, T Lu… - Clinical and …, 2023 - Wiley Online Library
This ethnic sensitivity analysis used data from the phase III POLARIX study (NCT03274492)
to assess polatuzumab vedotin pharmacokinetics (PKs) in Asian versus non‐Asian patients …
to assess polatuzumab vedotin pharmacokinetics (PKs) in Asian versus non‐Asian patients …
Expanding the use of real‐world data through the development of user‐friendly tools to support drug development: Example of an organ impairment dashboard
B Vora, E Velasquez, R Zhang, K Igras… - Pharmacology …, 2024 - pmc.ncbi.nlm.nih.gov
Real-world data (RWD), and more specifically electronic health record (EHR) data, have
gained increasing interest and utilization in the pharmaceutical industry over the past few …
gained increasing interest and utilization in the pharmaceutical industry over the past few …