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Prescription Assessment
Upon receipt of a request from a prescriber for a pharmacy preparation, the pharmacist must decide whether the request is appropriate and reasonable,...
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Simulation for Communication Skills Assessment
Simulation-based communication skills assessment is an important tool for healthcare providers to develop and improve their communication abilities....
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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In June 2021, FDA released a Draft Guidance on Sponsor Responsibilities for IND Safety Reporting and cited components of a recommended Safety...
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Assessment, Evaluation and Feedback of Simulation in Pharmacy Education
Simulation-based learning is a valuable educational approach that allows students to learn and practice their skills and competencies in a safe and...
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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 inform patients and healthcare...
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Assessment, Evaluation and Feedback of Simulation in Pharmacy Practice
Simulation-based pharmacy practice has emerged as a vital component in the education and training of pharmacy students and professionals, offering a...
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Assessment of vaccine management performance in health facilities of Mwanza Region, Tanzania: a cross-sectional study
BackgroundEffective Vaccine Management (EVM) initiative provides the platform needed to monitor and assess the vaccine supply chain system to...
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Patient Engagement and Patient Experience Data in Regulatory Review and Health Technology Assessment: A Global Landscape Review
BackgroundWorking with patients through meaningful patient engagement (PE) and incorporating patient experience data (PXD) is increasingly important...
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A Survey to Assess the Current Status of Structured Benefit-Risk Assessment in the Global Drug and Medical Device Industry
BackgroundThis industry survey was conducted to gain insight into the ways structured Benefit-Risk assessment (sBRA) of medical products is...
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A Structured Benefit-Risk Assessment Operating Model for Investigational Medicinal Products in the Pharmaceutical Industry
Robust and transparent formal benefit-risk (BR) analyses for medicinal products represent a means to better understand the appropriate use of...
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Homogeneity Assessment of Lyophilized Biological Drug Products During Process Performance Qualification
This chapter provides practitioners with a step-by-step guide for assessing homogeneity of lyophilized drug product batches manufactured during...
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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 optimization, Tufts CSDD collaborated...
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Methodological Approaches to Regional Ecological and Pharmacognostic Quality Assessment of Herbal Medicinal Raw Materials Using Voronezh Region as an Example
Amethodological approach to regional ecological and pharmacognostic quality assessment of medicinal plant raw materials has been developed. Modern...
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Analysis of Off-target Effects and Risk Assessment Leading from Preclinical to Clinical Trials of Gene-edited Therapeutic Products
ObjectiveConcerns about off-target effects (OTEs) of genomic DNA cleavages by gene-editing enzymes have been raised, especially for OTEs that go...
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Regulatory registration timelines of generic medicines in South Africa: Assessment of the performance of SAHPRA between 2011 and 2022
BackgroundVarious regulatory authorities are experiencing backlogs of applications which result in delayed access to medicines for patients. The...
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Relative Risk Assessment for Substandard Antibiotics Along the Manufacturing and Supply Chain: A Proof-of-Concept Study
BackgroundEnsuring good quality of antibiotics is essential for desired health outcomes. Risk assessment of products for quality issues arising along...
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Assessment of the Relationship Between Protocol Adherence, Study Complexity and Personnel in Surgical Clinical Trials
BackgroundIn order to improve quality and efficiency of surgical trials, we assessed protocols complexity and examined whether it influenced the...
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The role of drug regulatory authorities and health technology assessment agencies in sha** incentives for antibiotic R&D: a qualitative study
BackgroundFew antibiotics have entered the market in recent years despite the need for new treatment options. Some of the challenges of bringing new...
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Comprehensive Assessment of Risk-Based Quality Management Adoption in Clinical Trials
BackgroundRisk-based monitoring (RBM) and risk-based quality management (RBQM) offer a compelling approach to increase efficiency, speed and quality...
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Comparative Assessment of Drug Lag for Approved Oncology Targeted Therapies Between Saudi Arabia, the United States, and the European Union
IntroductionPharmaceutical regulation on a global scale is a complex process, with regulatory bodies overseeing various aspects, including licensing,...
