Current Use of Physiologically Based Pharmacokinetic modeling in New Medicinal Product Approvals at EMA.

Physiologically Based Pharmacokinetic (PBPK) Models are routinely used in drug development and therefore appear frequently in marketing authorization applications (MAAs) to the European Medicines Agency (EMA). For a model to be a key source of evidence for a regulatory decision, it must be considered qualified for the intended use. Advice on the data expected to allow qualification of a PBPK model or platform is provided in the EMA Guideline on the reporting of PBPK modeling and simulation.

The Evolution of NCI's Health Information National Trends Survey: Methods, Data, and Future Directions.

The National Cancer Institute's (NCI) Health Information National Trends Survey® (HINTS®), was conceived in 1997 during a multidisciplinary conference focused on risk communication that included attendees representing the fields of psychology, health behavior, health education, public health, clinical medicine, and health journalism. The key recommendation from the conference was for NCI to develop a premiere communication-specific population survey to track health and cancer communication-related phenomena. This led to NCI developing and launching HINTS in 2003.

Understanding diagnostic delays and health outcomes for inflammatory bowel disease: a mixed-methods study of patients' perspectives.

Purpose: Inflammatory bowel disease (IBD) is a chronic condition affecting the digestive system with symptoms that are often episodic, unpredictable, socially stigmatizing, and impact quality of life. While a timely diagnosis reduces the risk of complications and improves health outcomes, diagnostic delays (DDs) are common. Our study used narratives and data from patient-reported outcome measures (PROMs) of individuals diagnosed with IBD to examine: (1) What factors helped or hindered achieving a timely diagnosis of IBD? and (2) how do DDs relate to PROMs?

Methods: We conducted a mixed-methods study of 296 individuals diagnosed with IBD in Canada.

Implementing a global mentoring program: A call to action for mentorship in surgery.

Background: The Gender Equity Initiative in Global Surgery organization launched a mentorship program to address the limited opportunities available in low-and-middle-income countries (LMICs). We aimed to evaluate the utility of the virtual program in bridging this critical gap.

Methods: A retrospective review of program surveys containing quantitative and qualitative questions from 2022 to 2023 was performed.

Analysis of the immunomodulatory properties of mycobacterium cell wall fraction on the cytokine production of peripheral blood mononuclear cells of healthy dogs.

Background: Mycobacterium cell wall fraction (MCWF) is derived from nonpathogenic Mycobacterium phlei and is used as an immunomodulatory compound in clinical practice, yet its mode-of-action requires further research.

Objective: To evaluate the host response to MCWF in canine peripheral blood mononuclear cells (PBMCs) by using enzyme-linked immunosorbent assays (ELISA) and quantitative reverse transcription (qRT)-PCR for assessment of cytokines.

Animals: Eight healthy Labrador retrievers.