Results 321 to 330 of about 14,301,803 (394)

Vasovagal syncope: a prospective, randomized, crossover evaluation of the effect of propranolol, nadolol and placebo on syncope recurrence and patients’ well-being

open access: bronze, 2002
Panagiota Flevari   +5 more
openalex   +1 more source

Comparative single‐cell analysis of esophageal cancer subtypes reveals tumor microenvironment distinctions explaining varied immunotherapy responses

open access: yes
Cancer Communications, EarlyView.
Seungbyn Baek   +12 more
wiley   +1 more source

Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Food Effect of Bexicaserin in Healthy Participants: A First‐in‐Human Randomized, Double‐Blind, Placebo‐Controlled Single Ascending Dose Escalation Phase 1 Study

open access: yesClinical Pharmacology in Drug Development, EarlyView.
Abstract Bexicaserin (LP352) is a selective 5‐hydroxytryptamine 2C (5‐HT2C) superagonist in development for the treatment of seizures in developmental and epileptic encephalopathies (DEEs). This double‐blind, placebo‐controlled, single ascending dose (SAD) Phase 1 study aimed to assess the safety, tolerability, and pharmacokinetic (PK) and ...
Rosa Chan   +6 more
wiley   +1 more source

Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Ascending Doses and Dose Titration of Bexicaserin in Healthy Participants in a Randomized, Double‐Blind, Placebo‐Controlled Study

open access: yesClinical Pharmacology in Drug Development, EarlyView.
Abstract Bexicaserin (LP352) is a selective superagonist of the 5‐hydroxytryptamine 2C (5‐HT2C) receptor currently in development for the treatment of seizures that arise from developmental and epileptic encephalopathies. This phase 1, double‐blind, placebo‐controlled multiple ascending dose (MAD) study assessed the safety, tolerability, and ...
Jonathan Williams   +7 more
wiley   +1 more source

Supplementing Single‐Arm Trials with External Control Arms—Evaluation of German Real‐World Data

open access: yesClinical Pharmacology &Therapeutics, EarlyView.
As single‐arm trials (SATs) are increasingly used in pharmaceutical research, the validity of such study designs needs to be critically assessed. We characterize the feasibility of supplementing SATs with real‐world data (RWD)‐derived external control arms by determining the proportion of SATs on breast cancer and amyotrophic lateral sclerosis (ALS ...
Martin Russek   +2 more
wiley   +1 more source

Dose Optimization in Oncology Drug Development: Risk Factors for Postmarketing Requirements and Commitments

open access: yesClinical Pharmacology &Therapeutics, EarlyView.
Optimal dosing of oncological drugs is historically determined based on the “higher is better” paradigm. However, a paradigm shift in optimal dose selection has occurred in the development of new modalities, including molecularly targeted drugs, antibody drugs, and immunotherapies.
Hiroe Kitagaki   +3 more
wiley   +1 more source

Navigating the Real World: A Scoping Review of Structured Frameworks to Effectively Identify, Evaluate, and Select Real‐World Data Sources for Fit‐for‐Purpose Studies

open access: yesClinical Pharmacology &Therapeutics, EarlyView.
The potential of real‐world data (RWD), particularly from patient registries, has been increasingly recognized over the last decade by academia, regulators, and health technology assessment (HTA) bodies for its role in assessing a product's effectiveness and supporting regulatory submissions.
Sonia Zebachi   +13 more
wiley   +1 more source

Home - About - Disclaimer - Privacy