Leveraging Healthy Volunteers for Anticancer Drug Clinical Pharmacology Studies: A Review Article Featuring Futibatinib as an Example. [PDF]
ABSTRACT Early clinical development of anticancer drugs traditionally focused on exploring candidate treatments in patients. For instance, due to their cytotoxic action, administration of chemotherapies to healthy volunteers (HVs) for evaluation of their pharmacokinetic profiles was not considered feasible nor ethical from a safety and tolerability ...
van Haarst AD +5 more
europepmc +2 more sources
Model-Informed Approaches for Pediatric Type 2 Diabetes Evidence Generation: Insights from a Model-Based Longitudinal HbA1c Meta-Analysis from EMA Marketing Authorization Applications. [PDF]
Evidence generation for antihyperglycemic therapies in pediatric type 2 diabetes mellitus (T2DM) remains challenging, with most randomized trials failing to demonstrate statistically significant reductions in glycated hemoglobin (HbA1c), partly due to substantial between‐subject variability.
Colin PJ, Manolis E, Koomen JV.
europepmc +2 more sources
Supporting General Practitioners to Deprescribe Benzodiazepines and Z-Drugs in Primary Care: Findings From a Modified Delphi Study. [PDF]
ABSTRACT Long‐term use of benzodiazepines and Z‐drugs (collectively known as benzodiazepine receptor agonists; BZRAs) is associated with a range of adverse effects including dependence and withdrawal on stopping or reducing the dose. Deprescribing is recommended to improve patient outcomes and reduce medication‐related harm, but its implementation in ...
Oldenhof E +11 more
europepmc +2 more sources
How to Optimize Healthy Volunteer Screening and Enrolment in Clinical Trials: A Qualitative and Quantitative Approach to Evaluate Processes and Healthy Volunteers' Perceptions [PDF]
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,
Krohmer E +10 more
europepmc +2 more sources
Making the Case for Organ-on-Chip Platforms in Long-Acting Therapeutics Development. [PDF]
LATs release drug from a tissue‐resident depot over weeks to months, improving adherence, but their development is hampered by preclinical models that cannot reproduce the coupled tissue processes, sustained release, local microenvironment change, interstitial transport, immune and foreign‐body responses, and clearance that govern depot performance in ...
Gowans C +7 more
europepmc +2 more sources
Efficacy, safety and cost‐effectiveness of CAR‐T therapy
CAR T‐cells demonstrate high efficacy in blood cancers, including ALL, MM and DLBCL. Innovations target solid tumours despite challenges such as antigen escape. Combination therapies enhance the delivery and infiltration of CAR T cells. Toxicity, cost and resistance remain major barriers to clinical use.
Emina Karahmet Sher +7 more
wiley +1 more source
Lymphoma is a group of blood cancers that can appear in lymph nodes, blood, bone marrow, spleen, liver, or the central nervous system, which makes drug delivery and disease monitoring difficult. This review summarizes how nanomedicine technologies may improve targeted treatment and imaging, while carefully separating approved or guideline‐supported ...
Mohd Ahmar Rauf +5 more
wiley +1 more source
ABSTRACT Building the skills and knowledge necessary to practice evidence‐based veterinary medicine (EBVM) should occur throughout the veterinary curriculum. Operationalizing EBVM includes asking a clinical question in PICO format, searching the biomedical literature for evidence, critically appraising the evidence, and applying the evidence to make a ...
Virginia R. Fajt +4 more
wiley +1 more source
Fig leaves represent an underutilized source of bioactive compounds and promising functional ingredients. Emerging extraction technologies offer powerful tools to unlock their potential through sustainable and circular valorization, while addressing key safety and regulatory considerations.
Tamara Cilia Attard +4 more
wiley +1 more source
ABSTRACT Agricultural by‐products are increasingly valorized as food ingredients within circular food systems. However, their safety cannot be directly inferred from their corresponding primary commodities. Moreover, agricultural by‐products serve as secondary risk matrices by acting as reservoirs or accumulation points for microbiological hazards ...
Vinothini Boopathi +6 more
wiley +1 more source

