Results 1 to 10 of about 39,022 (246)

Using PBPK to Simulate Target Biopredictive Dissolution Profiles for Long-Acting Injectables - Where to Begin With Critical Bioavailability Attributes? [PDF]

open access: yesCPT Pharmacometrics Syst Pharmacol
ABSTRACT Long‐acting injectables (LAI) are of increasing interest as they facilitate improved medication adherence and exposure, with target plasma concentration levels maintained over weeks/months. Biopredictive in vitro dissolution tests can aid formulation development of LAIs and guide quality control dissolution testing by facilitating accelerated ...
Cleary H   +3 more
europepmc   +2 more sources

Bayesian Ordered Lattice Design for Phase I Clinical Trials. [PDF]

open access: yesStat Med
ABSTRACT We develop a new framework specifically for early Phase I clinical trials called Bayesian Ordered Lattice Design (BOLD). This study is motivated by two key factors. First, Phase I clinical trials typically involve relatively small sample sizes, which can make the use of prior information on dose‐limiting toxicity (DLT) rates highly significant.
Wang GM, Tatsuoka C.
europepmc   +2 more sources

Trabectedin plus CD13-targeted tissue factor tTF-NGR against advanced relapsed or refractory soft tissue sarcoma: translational data, clinical safety and efficacy. [PDF]

open access: yesSci Rep
Hessling K   +27 more
europepmc   +1 more source

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