Results 271 to 280 of about 2,535,602 (380)

Impact of Model‐Informed Drug Development on Drug Development Cycle Times and Clinical Trial Cost

open access: yesClinical Pharmacology &Therapeutics, EarlyView.
Model‐informed drug development (MIDD) integrates data to quantify benefit/risk informing objective drug discovery and development decisions. An additional critical benefit of MIDD is postulated to be improvement in trial and program efficiencies. While the application of MIDD has grown, there have been no clear examples across programs to demonstrate ...
Vaishali Sahasrabudhe   +4 more
wiley   +1 more source

Dose Selection for DuoBody®‐CD40x4‐1BB (GEN1042/BNT312) Using a mPBPK/RO Model Leveraging Preclinical and Clinical Data

open access: yesClinical Pharmacology &Therapeutics, EarlyView.
Optimizing target engagement for bispecific antibodies (bsAbs) is challenging, as bsAbs bind to two different targets in vivo to form a trimolecular complex (trimer), and likely display a bell‐shaped concentration–response curve. bsAbs trimer formation is expected to be related to efficacy and safety, and determining the dose level at which it is ...
Gaurav Bajaj   +16 more
wiley   +1 more source

SNP prioritization using a Bayesian probability of association. [PDF]

open access: yesGenet Epidemiol, 2013
Thompson JR   +23 more
europepmc   +1 more source

Confirmation of Fixed Quarterly Riliprubart Regimen in Patients with Cold Agglutinin Disease Using Population PK/PD and Exposure‐Response Analyses

open access: yesClinical Pharmacology &Therapeutics, EarlyView.
Riliprubart is a second‐generation, humanized immunoglobulin G4 that inhibits only the activated form of the C1s component of the proximal classical complement pathway. The clinical studies of riliprubart conducted thus far for the treatment of cold agglutinin disease (CAD), a rare autoimmune disease, include a Phase 1 first‐in‐human study in healthy ...
Timothy Chow   +3 more
wiley   +1 more source

Relationship between Dose, Factor IX Activity Levels and Bleeding Probability for rIX‐FP Prophylaxis in Hemophilia B: A Repeated Time‐to‐Event Analysis

open access: yesClinical Pharmacology &Therapeutics, EarlyView.
In hemophilia B, pharmacokinetic (PK)‐guided dosing of extended half‐life factor IX (EHL‐FIX) concentrates can secure targeted FIX exposure. Target FIX activity levels in plasma should be individually set primarily taking bleeding tendency into account, alongside the presence of target joints, physical activity, and preferred dosing schedules. In other
Sjoerd F. Koopman   +4 more
wiley   +1 more source

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