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Development of a Safety Toolkit to Influence Inclusion Barriers for Adolescents and Young Adults (AYA) in Adult Clinical Trials
Development of a Safety Toolkit to Influence Inclusion Barriers for Adolescents and Young Adults (AYA) in Adult Clinical Trials
Lack of long-term safety data for the AYA population has been identified as a key area that reduces enrolment of AYA in ad...
Post-approval Activities Providing Data on the Safety of Medication Use During Pregnancy and Lactation—A TransCelerate Perspective
Post-approval Activities Providing Data on the Safety of Medication Use During Pregnancy and Lactation—A TransCelerate Perspective
Pregnant and lactating women are frequently excluded from clinical trials, leading to a significant global unmet need for ...
Increasing the Utility of Real-World Data to Inform Public Health Decision Making Through a US-based Private–Public Partnership: 10 Lessons Learned from a Principled Approach to Rapid Pandemic RWE Generation
Increasing the Utility of Real-World Data to Inform Public Health Decision Making Through a US-based Private–Public Partnership: 10 Lessons Learned from a Principled Approach to Rapid Pandemic RWE Generation
In response to the COVID-19 pandemic, a collaborative public–private partnership was launched to harness evidence fr...
The Impact of the Inflation Reduction Act on Investment in Innovative Medicines: A Project-Level Analysis
The Impact of the Inflation Reduction Act on Investment in Innovative Medicines: A Project-Level Analysis
The impact of Medicare’s price negotiation on long-term pharmaceutical innovation and patient welfare remains one of...
Cross-sectional Study and Comparison between Japan and the United States on Special Regulatory Pathways for Expedited Drug Development and Approval
Cross-sectional Study and Comparison between Japan and the United States on Special Regulatory Pathways for Expedited Drug Development and Approval
Investigations on the relationship between the designated systems for drug development and regulatory processes in Japan a...
Beyond Reimbursement Status: Availability of Advanced Therapy Medicinal Products Across the European Union
Beyond Reimbursement Status: Availability of Advanced Therapy Medicinal Products Across the European Union
Advanced Therapy Medicinal Products (ATMPs) represent an innovative therapeutic approach with the potential to impact the ...
The Inflation Reduction Act’s Impact Upon Early-Stage Venture Capital Investments
The Inflation Reduction Act’s Impact Upon Early-Stage Venture Capital Investments
The Congressional Budget Office has stated there is no evidence of a systematic decrease in the percentage of venture capi...
Futility Interim Analyses - A Plea for Simplicity
Futility Interim Analyses - A Plea for Simplicity
Futility interim analyses remain a topic of anxiety for most clinical drug development teams. While they can significantly...
Key Findings from Pharmacovigilance Inspections in Saudi Arabia’s Pharmaceutical Sector
Key Findings from Pharmacovigilance Inspections in Saudi Arabia’s Pharmaceutical Sector
Pharmacovigilance is a critical component of pharmaceutical safety; it involves monitoring and assessing the safety of pha...
Navigating the Evolving Eurasian Economic Union’s Pharmaceutical Landscape: Streamlining Drug Registration for Market Access
Navigating the Evolving Eurasian Economic Union’s Pharmaceutical Landscape: Streamlining Drug Registration for Market Access
The Eurasian Economic Union was formed with the aim of achieving economic integration among the five countries, i.e., Russ...
The Inflation Reduction Act and Drug Development: Potential Early Signals of Impact on Post-Approval Clinical Trials
The Inflation Reduction Act and Drug Development: Potential Early Signals of Impact on Post-Approval Clinical Trials
The Inflation Reduction Act’s (IRA) Drug Price Negotiation Program (DPNP) may reduce incentives for industry investm...
Assessing the Value of Integrated Evidence Approaches in Drug Development
Assessing the Value of Integrated Evidence Approaches in Drug Development
The use of Integrated Evidence Plans (IEPs) by the pharmaceutical industry has expanded in recent years with the aim of op...
Untangling the Biosimilars Interchangeability Puzzle: A Provocative Dive into Concepts and Terminology, and Developing a Strategy to Minimize Uncertainties from Interchangeability
Untangling the Biosimilars Interchangeability Puzzle: A Provocative Dive into Concepts and Terminology, and Developing a Strategy to Minimize Uncertainties from Interchangeability
The interchangeability of bioimilars (off-patent biologics) is a topic of ongoing debate in the literature. In the US, the...
Incorporating Patient Input into the Target Product Profile
Incorporating Patient Input into the Target Product Profile
Target product profiles (TPP) are summaries of characteristics which drug developers expect to be necessary for a product ...
The Quality Quotient: Rethinking PSURs for Regulatory Excellence
The Quality Quotient: Rethinking PSURs for Regulatory Excellence
Regulatory Authorities demand high-quality safety reporting to ensure proper oversight of marketed medicinal products. The...
Quality of Randomized Controlled Trials in the Association of Southeast Asian Nations (ASEAN) – A Systematic Review
Quality of Randomized Controlled Trials in the Association of Southeast Asian Nations (ASEAN) – A Systematic Review
This study aimed to assess the quality and characteristics of RCTs in the ASEAN Member States (AMS) during a decade of har...
Has FDA’s Drug Development Tools Qualification Program Improved Drug Development?
Has FDA’s Drug Development Tools Qualification Program Improved Drug Development?
The Drug Development Tools (DDTs) Qualification program creates a pathway to evaluate Clinical Outcome Assessments (COAs) ...
A Comprehensive Retrospective Analysis of Trends and Strategic Implications of 505(b)(2) Approvals (2019–2023)
A Comprehensive Retrospective Analysis of Trends and Strategic Implications of 505(b)(2) Approvals (2019–2023)
The 505(b)(2) pathway, established by the USFDA, enables faster approval of new drug applications (NDAs) by allowing parti...
Effort minimization: A permanent, dynamic, and surmountable influence on physical activity
Volume 14, December 2025, 100971Author links open overlay panelSilvio Maltagliati a †, Layan Fessler b †, Qian Yu c, Zhiha...
Erratum to “Biomechanics associated with tibial stress fracture in runners: A systematic review and meta-analysis” [J Sport Health Sci 12 (2023) 333–342]
Volume 14, December 2025, 101019Author links open overlay panelClare E. Milner a, Eric Foch b, Joseph M Gonzales a, Drew P...
Comparison of objectively measured and estimated cardiorespiratory fitness to predict all-cause and cardiovascular disease mortality in adults: A systematic review and meta-analysis of 42 studies representing 35 cohorts and 3.8 million observations
We found 14% and 16% reductions in all-cause and CVD mortality risk per higher metabolic equivalent of task ((MET) i.e., 3...
Decorin, an exercise-induced secretory protein, is associated with improved prognosis in breast cancer patients but does not mediate anti-tumorigenic tissue crosstalk in mice
However, decorin overexpression in murine muscle or systemic injection of recombinant decorin into mouse models of breast ...
International norms for adult handgrip strength: A systematic review of data on 2.4 million adults aged 20 to 100+ years from 69 countries and regions
BackgroundMuscular strength is a powerful marker of current health status and robust predictor of age-related disease and ...
Commentary on “A systematic review and meta-analysis comparing objectively measured and estimated fitness to predict all-cause and cardiovascular disease mortality in adults”
Cookies are used by this site. Cookie SettingsAll content on this site: Copyright © 2025 Elsevier B.V., its licensors, an...
Does ischemic preconditioning enhance sports performance more than placebo or no intervention? A systematic review with meta-analysis
BackgroundIschemic preconditioning (IPC) is purported to have beneficial effects on athletic performance, although finding...
Sport climbing performance determinants and functional testing methods: A systematic review
Test validity resulted high for climbing-specific cardiorespiratory endurance, muscular -strength, -endurance and -power. ...
Effect of exercise for patients with advanced lung cancer and cancer-related fatigue: A systematic review and meta-analysis
BackgroundCancer-related fatigue (CRF) is a significant burden for patients with advanced lung cancer. While exercise is r...
Sexual dimorphism on the acute effect of exercise in the morning vs. evening: A randomized crossover study
BackgroundMammalian cells possess molecular clocks, the adequate functioning of which is decisive for metabolic health. Ex...
Asymmetry in sprinting: The myth of perfection and the reality of performance
Volume 14, December 2025, 101025Author links open overlay panelOlivier GirardShow morePrevious article in issueNext articl...
Exercised gut microbiota improves vascular and metabolic abnormalities in sedentary diabetic mice through gut‒vascular connection
BackgroundExercise elicits cardiometabolic benefits, reducing the risks of cardiovascular diseases and type 2 diabetes. Th...
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