Results 221 to 230 of about 261,789 (293)

Digital Transformation of Medicines Regulation in Africa—Perspectives from a Stakeholder Convening

open access: yesClinical Pharmacology &Therapeutics, EarlyView.
Regulatory authorities worldwide are developing strategies to integrate artificial intelligence (AI) into the lifecycle of health products, technologies, and medicines. While regulators share goals of improving efficiency, strengthening decision‐making, and protecting public health, their approaches differ according to institutional structures ...
Christelna Reyneke   +12 more
wiley   +1 more source

Application of Virtual Twin PBPK Models in Individuals with Obesity via CYP3A4 Phenotyping Using Endogenous Biomarker Data

open access: yesClinical Pharmacology &Therapeutics, EarlyView.
Plasma 4β‐hydroxycholesterol (4β‐OHC) normalized for the levels of its parent cholesterol (4β‐OHC/C) is an endogenous biomarker for hepatic CYP3A4. This study evaluated CYP3A4 activity longitudinally in individuals while their obesity status was changing. 4β‐OHC/C was measured pre‐surgery (n = 54) and 2 years after Roux‐en‐Y gastric bypass (n = 30) and
Nihan Izat   +6 more
wiley   +1 more source

Impact of Opioid Limiting Legislation on Prescribing in Adolescent Breast Surgery at a Tertiary Pediatric Hospital. [PDF]

open access: yesPlast Reconstr Surg Glob Open
Kennedy CC   +10 more
europepmc   +1 more source

Navigating the Prescription Drug Information System

open access: yesClinical 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

Maternal and Neonatal Complications Associated with Breast Cancer Systemic Treatments—A VigiBase Disproportionality Analysis Study

open access: yesClinical Pharmacology &Therapeutics, EarlyView.
Pregnancy‐associated breast cancer (PrBC) presents therapeutic challenges. Understanding maternal–fetal safety of systemic anticancer therapies is critical. We performed a case/non‐case disproportionality analysis using the WHO global pharmacovigilance database up to January 2024, to evaluate maternal–fetal outcomes associated with breast cancer (BC ...
Rayan Kabirian   +12 more
wiley   +1 more source

Calibrated Autonomy: China's 2026 Business Mediation Ordinance and the Reconfiguration of Dispute Resolution

open access: yesConflict Resolution Quarterly, EarlyView.
ABSTRACT This article argues that China's 2026 Business Mediation Ordinance represents neither progress toward rule of law nor retreat from it. I propose instead that we are witnessing something I call “calibrated autonomy”—the strategic construction of spaces for private ordering that remain tethered to Party‐State oversight through multiple ...
M. Francis Cao
wiley   +1 more source

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