Results 211 to 220 of about 648,282 (342)

Factors associated with placebo response rate in randomized controlled trials of antiseizure medications for focal epilepsy. [PDF]

open access: yesEpilepsia
Kerr WT   +8 more
europepmc   +1 more source

Adverse immunostimulation in early phase clinical trials: Key findings and recommendations based on the investigator's clinical experience

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
Problem setting The emergence of therapeutic proteins has coincided with an increase of acute adverse immunostimulation (AIS). AIS has occured in clinical trials despite compliance with regulatory guidelines on preclinical evaluation and its incidence is anticipated to increase even further.
Juliette A. van den Noort   +8 more
wiley   +1 more source

Population pharmacokinetics and exposure–response analysis of durvalumab in patients with resectable stage II to IIIB (N2) NSCLC in the phase III AEGEAN study

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
Aims In the AEGEAN study, perioperative durvalumab plus platinum‐based neoadjuvant chemotherapy for patients with resectable stage II to IIIB (N2) non‐small‐cell lung cancer (NSCLC) demonstrated a favourable benefit–risk profile. This study evaluated population pharmacokinetics (PopPK) and exposure–response (ER) relationships of durvalumab in patients ...
Xiaoying Zhao   +12 more
wiley   +1 more source

A Participant-Level Integrative Data Analysis of Differential Placebo Response for Suicidal Ideation and Nonsuicidal Depressive Symptoms in Clinical Trials of Intravenous Racemic Ketamine. [PDF]

open access: yesInt J Neuropsychopharmacol, 2022
Bloomfield-Clagett B   +10 more
europepmc   +1 more source

Pharmacokinetics, pharmacodynamics and safety of vutiglabridin after multiple oral administrations in healthy female and obese subjects

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
Aims Vutiglabridin (HSG4112) is a novel drug under clinical development for antiobesity treatment. This study aimed to evaluate the pharmacokinetics (PKs) and safety of vutiglabridin after multiple oral administrations in healthy Korean female and obese subjects and explore short‐term pharmacodynamic (PD) responses.
Sooyoun Lee   +5 more
wiley   +1 more source

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