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Data from: A critical appraisal of clinical trials conducted and subsequent drug approvals in India and South Africa
- 负责人：
- DOI：
- doi:10.5061/dryad.013hq
- 摘要：
- ipation of test centres in India and/or South Africa, 39.6% (India) clinical trials and 60.1% (South Africa) clinical trials led to market authorisation in the EU
Data from: Quality expectations and tolerance limits of trial master files (TMF) - Developing a risk-based approach for quality assessments of TMFs
- 负责人：
- DOI：
- doi:10.5061/dryad.t2f61
- 摘要：
- and published by the EMA in 2014. Based on quality risk management principles in clinical trials the authors defined the quality expectations for the different
Data from: Progressive parkinsonism in older adults is related to the burden of mixed-brain pathologies
- 负责人：
- DOI：
- doi:10.5061/dryad.vn42tj2
- 摘要：
- of parkinsonism in older adults. Methods: We used data from decedents who had undergone annual clinical testing prior to death and structured brain au
\u2022\tRegulatory requirement for drug development and approval in United States: review
- 负责人：
- 关键词：
- 111701 Aboriginal and Torres Strait Islander Health 111001 Aged Care Nursing 111702 Aged Health Care 110301 Anaesthesiology 110901 Autonomic Nervous System 111501 Basic Pharmacology Biomarkers 110601 Biomechanics 111201 Cancer Cell Biology 111202 Cancer Diagnosis
- DOI：
- doi:10.6084/m9.figshare.3381274.v1
- 摘要：
- involving drugdiscovery, laboratory development, animal studies, clinicaltrials, and regulatory registration. This lengthy process isnecessary to assure
Data from: Primary care clinics can be a source of exposure to virulent Clostridium (now Clostridioides) difficile: an environmental screening study
- 负责人：
- DOI：
- doi:10.5061/dryad.6nk2n87
- 摘要：
- C. difficile, we measured the frequency of environmental contamination with spores in clinic examination rooms and hospital rooms in Dallas-Fort Worth (DFW) area
Data from: Medical-device recalls in the UK and the device-regulation process: retrospective review of safety notices and alerts
- 负责人：
- DOI：
- doi:10.5061/dryad.585t4
- 摘要：
- er of recalls, the clinical data requirements for regulation and the impact on patient safety are poorly understood. Methods: The authors defined a device usi
Data from: Clinician-rated measures for distal symmetrical axonal polyneuropathy: ACTTION systematic review
- 负责人：
- DOI：
- doi:10.5061/dryad.24bt62r
- 摘要：
- agencies. Reliable and responsive outcome measures are integral to developing new DSP treatments. Multiple clinician-rated measures that incorporate
tions of randomized clinical trials
- 负责人：
- DOI：
- doi:10.5061/dryad.3s6j7
- 摘要：
- . Methods and Findings: We used a retrospective cohort of randomized clinical trials (RCTs) based on archived protocols approved by six research ethic
Data from: Influence of needle-insertion depth on epidural spread and clinical outcomes in caudal epidural injections: a randomized clinical trial
- 负责人：
- 关键词：
- DOI：
- doi:10.5061/dryad.8pp13mm
- 摘要：
- the achievement of successful epidurograms and patient-reported clinical outcomes following different needle-insertion depths during CESI. Methods
Data from: Mathematical modeling for the prediction of cerebral white matter lesions based on clinical examination data
- 负责人：
- 关键词：
- 2016-2017;cerebral white matter lesions;clinical examination data;mathematical modeling;Homo Sapiens
- DOI：
- doi:10.5061/dryad.73bh2q8
- 摘要：
- ng clinical data for 1,904 examinees (988 males and 916 females) from medical checkups that did include the head MRI. The logistic regression model was selected
