Results 171 to 180 of about 8,550,299 (291)

How to Optimize Healthy Volunteer Screening and Enrolment in Clinical Trials: A Qualitative and Quantitative Approach to Evaluate Processes and Healthy Volunteers' Perceptions

open access: yesClinical Pharmacology &Therapeutics, EarlyView.
Healthy volunteers (HVs) are essential for phase I trials, yet their recruitment and screening remain resource‐intensive and ethically complex. High screening failure (SF) rates highlight the need to evaluate and understand all aspects of the enrolment processes. We analyzed SF patterns in a large German HV cohort and explored participants' motivations,
Evelyn Krohmer   +10 more
wiley   +1 more source

Prevalence and postural risk factors associated with musculoskeletal disorders among medical laboratory personnel in Kashan in 2012

open access: yes, 2016
Background and aims: Musculoskeletal disorders are the most prevalent occupational injuries and disabilities in the world. One of the most important risk factors of these disorders is awkward posture.
Derakhshan, M.   +4 more
core  

Transcriptomic Profiling of SLC and ABC Transporters in the Human Term Placenta

open access: yesClinical Pharmacology &Therapeutics, EarlyView.
Solute carriers (SLC) and ATP‐binding cassette (ABC) transporters are essential for placental solute exchange and fetal protection, yet their transcriptomic profiles in the human placenta remain poorly characterized. Although fetal sex influences placental development and function, its impact on transporter expression is unclear.
Elijah Marsh Jung   +12 more
wiley   +1 more source

Phase I Evaluation of Siltartoxatug, a First‐in‐Class Anti‐Tetanus Monoclonal Antibody: Safety, Pharmacokinetics and Pharmacodynamics in Healthy Australian and Chinese Populations

open access: yesClinical Pharmacology &Therapeutics, EarlyView.
Siltartoxatug, a first‐in‐class monoclonal antibody targeting tetanus toxin for post‐exposure prophylaxis, was evaluated in two phase I trials in Australian and Chinese healthy adults. In these randomized, double‐blind, placebo‐controlled, dose‐escalation studies, participants received a single intramuscular injection of siltartoxatug (10–250 μg/kg) or
Xinyu Liu   +15 more
wiley   +1 more source

A Practical Guide to Implementing Real‐World Evidence as Primary Basis for Approval and Label Expansion

open access: yesClinical Pharmacology &Therapeutics, EarlyView.
In June 2026, the FDA issued a revised draft guidance describing the circumstances in which one adequate and well‐controlled clinical investigation plus confirmatory evidence may satisfy the statutory substantial evidence standard for establishing efficacy and safety. Confirmatory evidence includes real‐world evidence (RWE).
Tracy J. Mayne   +2 more
wiley   +1 more source

Sustainability Assessment of Micro, Small, and Medium Enterprises: A Systematic Review and Hybrid Architecture for Credible, Salient, and Legitimate Knowledge Governance

open access: yesCorporate Social Responsibility and Environmental Management, EarlyView.
ABSTRACT Sustainability assessment advances corporate social responsibility toward inclusive development. Widely recognized approaches prove inadequate for micro, small, and medium enterprises (MSMEs), resulting in fragmented proliferation that hinders cumulative knowledge.
Luísa Couto Gonçalves de Souza   +2 more
wiley   +1 more source

High‐Dimensional Spectral Flow Cytometry Panel for Immunophenotypic Characterization of Fixed Whole Blood Samples

open access: yesCytometry Part A, EarlyView.
ABSTRACT Peripheral blood mononuclear cells (PBMCs) are commonly used for immune profiling in clinical research, but their isolation and cryopreservation present logistical challenges, particularly in settings with limited access to research facilities. To address this, we implemented a whole blood fixation protocol to preserve surface protein epitopes
Vaishnavi Parthasarathy   +8 more
wiley   +1 more source

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