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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...
Latest Developments in “Adaptive Enrichment” Clinical Trial Designs in Oncology
Latest Developments in “Adaptive Enrichment” Clinical Trial Designs in Oncology
As cancer has become better understood on the molecular level with the evolution of gene sequencing techniques, considerat...
A Framework for the Use and Likelihood of Regulatory Acceptance of Single-Arm Trials
A Framework for the Use and Likelihood of Regulatory Acceptance of Single-Arm Trials
Single-arm clinical trials (SAT) are common in drug and biologic submissions for rare or life-threatening conditions, espe...
Comparison of Product Features and Clinical Trial Designs for the DTx Products with the Indication of Insomnia Authorized by Regulatory Authorities
Comparison of Product Features and Clinical Trial Designs for the DTx Products with the Indication of Insomnia Authorized by Regulatory Authorities
Digital therapeutics (DTx) have attracted attention as the substitutes or add-ons to conventional pharmacotherapy and the ...
Paediatric Drug Development in Japan: Current Status and Future Challenges
Paediatric Drug Development in Japan: Current Status and Future Challenges
Until around 2000, the number of medicinal products labelled for paediatric use was limited worldwide. Regulatory measures...
A Clustering Ensemble Method for Drug Safety Signal Detection in Post-Marketing Surveillance
A Clustering Ensemble Method for Drug Safety Signal Detection in Post-Marketing Surveillance
Post-marketing surveillance refers to the process of monitoring the safety of drugs once they reach the market, after the ...
Pediatric-Specific Drug Loss Issue in Japan: Comparison of Pediatric Development Status Between Japan and the United States
Pediatric-Specific Drug Loss Issue in Japan: Comparison of Pediatric Development Status Between Japan and the United States
The lack of label information for the pediatric population has been a global issue, leading to the introduction of several...
Abstract Versus Concrete Risk Identification in Clinical Research in Japan: Randomized and Prospective Pilot Research on the Effect of Risk Reduction Activities in a Risk-Based Approach
Abstract Versus Concrete Risk Identification in Clinical Research in Japan: Randomized and Prospective Pilot Research on the Effect of Risk Reduction Activities in a Risk-Based Approach
The risk-based approach (RBA) of clinical trial was first introduced in 2011–2012. RBA necessitates implementing ris...
The Effect of Antihyperglycemic Medications on COVID-19: A Meta-analysis and Systematic Review from Observational Studies
The Effect of Antihyperglycemic Medications on COVID-19: A Meta-analysis and Systematic Review from Observational Studies
Diabetes, a chronic disease worldwide, may be associated with a poorer prognosis in patients with coronavirus disease 2019...
Safety of Linagliptin in Patients with Type 2 Diabetes Mellitus: A Systematic Review and Meta-analysis of Randomized Clinical Trials
Safety of Linagliptin in Patients with Type 2 Diabetes Mellitus: A Systematic Review and Meta-analysis of Randomized Clinical Trials
Linagliptin is an oral dipeptidyl peptidase DPP‐4 inhibitor, which is indicated for the treatment of Type 2 diabetes...
How Aggregate Safety Assessment Planning Supports Investigational New Drug Safety Reporting Decisions
How Aggregate Safety Assessment Planning Supports Investigational New Drug Safety Reporting Decisions
In June 2021, FDA released a Draft Guidance on Sponsor Responsibilities for IND Safety Reporting and cited components of a...
A Survey to Assess the Current Status of Structured Benefit-Risk Assessment in the Global Drug and Medical Device Industry
A Survey to Assess the Current Status of Structured Benefit-Risk Assessment in the Global Drug and Medical Device Industry
This industry survey was conducted to gain insight into the ways structured Benefit-Risk assessment (sBRA) of medical prod...
Correction: Comparative Assessment of Drug Lag for Approved Oncology Targeted Therapies Between Saudi Arabia, the United States, and the European Union
Correction: Comparative Assessment of Drug Lag for Approved Oncology Targeted Therapies Between Saudi Arabia, the United States, and the European Union
Cite this articleAlnuhait, M., Alshammari, A., Alharbi, M. et al. Correction: Comparative Assessment of Drug Lag for Appro...
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