Model‐Informed Evaluation of Hydroxyurea Exposure During Lactation
Clinical Pharmacology &Therapeutics, EarlyView.Hydroxyurea is a cornerstone therapy for sickle cell anemia; however, evidence guiding its use during lactation remains limited. This study aimed to develop a population pharmacokinetic (PK) model to characterize hydroxyurea disposition in maternal plasma and breast milk, and to quantify infant exposure under clinically relevant breastfeeding scenarios.
Anhar Hosawi +5 more
wiley +1 more source
Does Depressed Mood Affect Accuracy of Perceptions of Cognitive Function in Multiple Sclerosis? The Role of Momentary Depressive Symptoms in the Correspondence Between Subjective and Objective Cognition in Multiple Sclerosis. [PDF]
Arch Phys Med RehabilMistretta EG +5 more
europepmc +1 more source
Clinical Pharmacology &Therapeutics, EarlyView.Regulatory bodies play a central role in providing guidance that enables safe and effective use of artificial intelligence tools in medicine development and evaluation. Regulators can also act as catalysts for regulatory science research. To inform these efforts, a European‐wide survey was conducted to solicit stakeholder perspectives on the priority ...
Luis C. Pinheiro +9 more
wiley +1 more source
Mood dynamics in adolescents and young adults with and without a history of suicidal thoughts and actions: a network approach. [PDF]
BMC PsychiatryVoss C +5 more
europepmc +1 more source
Navigating the Prescription Drug Information System
Clinical Pharmacology &Therapeutics, EarlyView.Information on new prescription drugs is increasingly complex and fragmented, posing challenges for healthcare professionals, patients, and payers. Clinicians require concise, actionable guidance to support prescribing decisions, while patients seek to balance benefits and harms when making decisions aligned with their treatment goals.
Irina V. Wang +11 more
wiley +1 more source
Auricular Point Acupressure Self-Management (APA-SM) program for chronic musculoskeletal pain among rural populations: a protocol for a pragmatic, randomized controlled trial. [PDF]
BMJ OpenKawi J +8 more
europepmc +1 more source
Clinical Pharmacology &Therapeutics, EarlyView.External control arms (ECAs) have emerged as important tools to provide benchmark evidence on comparator effectiveness and thereby support regulatory decision making in situations where randomized controlled trials are difficult to conduct. However, how key methodological elements for ECAs are documented and implemented in practice and how residual ...
Suguru Okami, Alexandros Sagkriotis
wiley +1 more source
Clinical Pharmacology &Therapeutics, EarlyView.Precision medicine offers the opportunity to improve the benefit–risk profile of new therapies by prospectively identifying patients most likely to respond or least likely to experience harm; however, its systematic integration into drug development remains inconsistent outside oncology.
Ingrid Holst‐Laubjerg +1 more
wiley +1 more source
Advancing our understanding of valued living: An ecological momentary assessment of behavioral and experiential aspects of valued actions, well-being, and emotional distress. [PDF]
Appl Psychol Health Well BeingSarrión P +5 more
europepmc +1 more source
Clinical Pharmacology &Therapeutics, EarlyView.Marketing authorizations for oncology drugs are often based on single‐arm trials (SATs), and real‐world data‐based external comparator cohorts (ECCs) are increasingly explored to contextualize results. In retrospective studies, comparators may be identified by time of diagnosis but included based on time of relapse; such sampling strategies can ...
Mikkel Runason Simonsen +6 more
wiley +1 more source