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Characteristics of Anticancer Drugs Approved Under the Accelerated Approval Program in the US: Success or Failure in Converting to Regular Approval
Characteristics of Anticancer Drugs Approved Under the Accelerated Approval Program in the US: Success or Failure in Converting to Regular Approval
Accelerated approval (AA) program expedites access to promising drugs for life-threatening conditions, particularly in onc...
US FDA’s Dose Optimization Postmarketing Requirements and Commitments of Oncology Approvals and the Impact on Product Labels from 2010 to 2022: An Emerging Landscape from Traditional to Novel Therapies
US FDA’s Dose Optimization Postmarketing Requirements and Commitments of Oncology Approvals and the Impact on Product Labels from 2010 to 2022: An Emerging Landscape from Traditional to Novel Therapies
Dose optimization is a focal point of many US Food and Drug Administration (FDA) drug approvals. We sought to understand t...
Predicting the Addition of Information Regarding Clinically Significant Adverse Drug Reactions to Japanese Drug Package Inserts Using a Machine-Learning Model
Predicting the Addition of Information Regarding Clinically Significant Adverse Drug Reactions to Japanese Drug Package Inserts Using a Machine-Learning Model
To develop a machine learning (ML)-based model for predicting the addition of clinically significant adverse reaction (CSA...
Asia Core Dossier: Standardizing CMC Requirement to Facilitate Best Case Submissions in Asia
Asia Core Dossier: Standardizing CMC Requirement to Facilitate Best Case Submissions in Asia
When the regulatory requirements are converged or harmonized, the country-specific variance of countries is often reduced ...
Regulations Governing Medicines for Maternal and Neonatal Health: A Landscape Assessment
Regulations Governing Medicines for Maternal and Neonatal Health: A Landscape Assessment
Limited evidence related to the safety or efficacy of medicines in pregnancy and during breastfeeding is available to info...
An Overview of Current Statistical Methods for Implementing Quality Tolerance Limits
An Overview of Current Statistical Methods for Implementing Quality Tolerance Limits
In 2016, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use updated i...
A Cross-National Comparison of Biosimilars Pricing in Argentina, Australia, Brazil, and Italy
A Cross-National Comparison of Biosimilars Pricing in Argentina, Australia, Brazil, and Italy
Biosimilar medicines are defined as biological products highly similar to an already licensed biological product (RP). The...
Industry Perceptions and Experiences with the Access Consortium New Active Substance Work-Sharing Initiative (NASWSI): Survey Results and Recommendations
Industry Perceptions and Experiences with the Access Consortium New Active Substance Work-Sharing Initiative (NASWSI): Survey Results and Recommendations
The Access Consortium New Active Substance Work-Sharing Initiative, or “Access” for simplicity, allows regulat...
Building a Competency Framework to Integrate Inter-disciplinary Precision Medicine Capabilities into the Medical Technology and Pharmaceutical Industry
Building a Competency Framework to Integrate Inter-disciplinary Precision Medicine Capabilities into the Medical Technology and Pharmaceutical Industry
Integration of precision medicine (PM) competencies across the Medical Technology and Pharmaceutical industry is critical ...
Bridging the Gap: A Comparative Investigation of Pharmaceutical Excipient Regulations
Bridging the Gap: A Comparative Investigation of Pharmaceutical Excipient Regulations
Since the awareness of adverse effects associated with pharmaceutical excipients in drug formulations, these excipients ar...
Quantitative Investigation on Exposure to Potentially Harmful Excipients by Injection Drug Administration in Children Under 2 Years of Age and Analysis of Association with Adverse Events: A Single-Center, Retrospective Observational Study
Quantitative Investigation on Exposure to Potentially Harmful Excipients by Injection Drug Administration in Children Under 2 Years of Age and Analysis of Association with Adverse Events: A Single-Center, Retrospective Observational Study
Potentially harmful excipients (PHEs) for children have been reported and the need for information collection has been adv...
The Renovation of Good Clinical Practice: A Framework for Key Components of ICH E8
The Renovation of Good Clinical Practice: A Framework for Key Components of ICH E8
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use’s (ICH) reno...
A Case Study Assessment on the Rationale for, and Relevance of, Non-Core Protocol Data
A Case Study Assessment on the Rationale for, and Relevance of, Non-Core Protocol Data
To better understand the nature of Non-Core procedures and derive new insight into protocol simplification and optimizatio...
Evaluation of a Pilot: Inspection Facilitation and Collaboration Using a Mixed Reality Device
Evaluation of a Pilot: Inspection Facilitation and Collaboration Using a Mixed Reality Device
The COVID-19 pandemic forced industry and national regulatory authorities (NRAs) to think about innovative ways to ensure ...
Use of Real-World Evidence in Regulatory Decisions for Traditional Chinese Medicine: Current Status and Future Directions
Use of Real-World Evidence in Regulatory Decisions for Traditional Chinese Medicine: Current Status and Future Directions
Traditional Chinese medicine (TCM) is a valuable resource unique to China with a long history of human use and clinical pr...
Analysis on the Marketing Trend and Approval Lag of Imported Orphan Drugs from 2010 to 2021 in China
Analysis on the Marketing Trend and Approval Lag of Imported Orphan Drugs from 2010 to 2021 in China
In order to meet the unmet needs of rare disease patients in China, importing orphan drugs is an important way. The object...
Decisions on Non-oncology Breakthrough Therapy Designation Requests in 2017–2019
Decisions on Non-oncology Breakthrough Therapy Designation Requests in 2017–2019
The US Food and Drug Administration’s Breakthrough Therapy Designation (BTD) program is intended to facilitate and e...
Risk-Based Quality Management: Who Should Be in the Room and When While Assessing Risks During a Clinical Trial?
Risk-Based Quality Management: Who Should Be in the Room and When While Assessing Risks During a Clinical Trial?
Authors and AffiliationsDaiichi Sankyo, Inc., 211 Mount Airy Road, Basking Ridge, NJ, 07920, USATerry Katz MSContego Medic...
An Update from the Benchmark Survey of phactMI™ Member Companies on Providing Medical Information in the Digital Space
An Update from the Benchmark Survey of phactMI™ Member Companies on Providing Medical Information in the Digital Space
The Pharma Collaboration for Transparent Medical Information (phactMI™) benchmarking survey of 32 pharmaceutical com...
Use of Real-World Evidence for Drug Regulatory Decisions in China: Current Status and Future Directions
Use of Real-World Evidence for Drug Regulatory Decisions in China: Current Status and Future Directions
Real-world data (RWD) and real-world evidence (RWE) have garnered great interest for supporting drug research and developm...
Strategy for Generating Blinded Evidence for Single-Arm Trials with External Controls Using Expert Review of Home Video
Strategy for Generating Blinded Evidence for Single-Arm Trials with External Controls Using Expert Review of Home Video
Neurodegenerative diseases cause developmental delays and loss of milestones in infants and children. However, scalable ou...
Global Postmarket Pharmacovigilance: A Generic Drug Perspective
Global Postmarket Pharmacovigilance: A Generic Drug Perspective
Despite the recognized need for generic drug pharmacovigilance harmonization efforts, only a few studies compared generic ...
Identification of Confusing Medicine Proprietary Names: Toward Safe Medicine Use—A Cross-Sectional Study in Sri Lanka
Identification of Confusing Medicine Proprietary Names: Toward Safe Medicine Use—A Cross-Sectional Study in Sri Lanka
Look-alike sound-alike (LASA) medications have similar pronunciation (phonetic) and/or manifestation (orthographic), which...
Direct-to-Consumer Genetic Testing: A Comprehensive Review
Direct-to-Consumer Genetic Testing: A Comprehensive Review
Emerged in the early 2000s, direct-to-consumer (DTC) genetic testing has helped consumers access and understand their gene...
Nature of the Interaction of Alpha-D-Mannose and Escherichia coli Bacteria, and Implications for its Regulatory Classification. A Delphi Panel European Consensus Based on Chemistry and Legal Evidence
Nature of the Interaction of Alpha-D-Mannose and Escherichia coli Bacteria, and Implications for its Regulatory Classification. A Delphi Panel European Consensus Based on Chemistry and Legal Evidence
The nature of alpha-D-mannose—natural aldohexose sugar, C-2 glucose epimer, whose intended use is for preventing uri...
Aiding the Adoption of Master Protocols by Optimizing Patient Engagement
Aiding the Adoption of Master Protocols by Optimizing Patient Engagement
Master protocols (MPs) are an important addition to the clinical trial repertoire. As defined by the U.S. Food and Drug Ad...
Landscape Analysis of Generic Availability for Oncologic Drugs
Landscape Analysis of Generic Availability for Oncologic Drugs
Improving generic drug development in oncology is a key long-term goal in providing safe, effective, and affordable care t...
A Mixed Methods Study to Explore Relevant Metrics for a Results Framework Measuring the Public Health Impact of Reliance-Based Pathways
A Mixed Methods Study to Explore Relevant Metrics for a Results Framework Measuring the Public Health Impact of Reliance-Based Pathways
Reliance-based pathways for the marketing authorization of medical products have been identified as valuable regulatory to...
Digital Health Technologies in Clinical Trials: An Ontology-Driven Analysis to Inform Digital Sustainability Policies
Digital Health Technologies in Clinical Trials: An Ontology-Driven Analysis to Inform Digital Sustainability Policies
Digital health technologies (DHTs) can facilitate the execution of de-centralized trials that can offer opportunities to r...
Statistical Evaluation of Responder Analysis in Stem Cell Clinical Trials
Statistical Evaluation of Responder Analysis in Stem Cell Clinical Trials
In evaluating treatment efficacy, there is an ongoing discussion about which endpoint is more efficient to represent the t...
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