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Mitigating the Nocebo Effect in Biosimilar Use and Switching: A Systematic Review
Mitigating the Nocebo Effect in Biosimilar Use and Switching: A Systematic Review
In the context of biosimilar use and switching, a patient’s negative perception of a biosimilar might trigger a noce...
European Pharmaceutical Industry Medical Information: A Role to Play in the Provision of Medicine-Related Information to Patients
European Pharmaceutical Industry Medical Information: A Role to Play in the Provision of Medicine-Related Information to Patients
European pharmaceutical companies have a professional and legal obligation to provide objective, factual and non-promotion...
Automated Mass Extraction of Over 680,000 PICOs from Clinical Study Abstracts Using Generative AI: A Proof-of-Concept Study
Automated Mass Extraction of Over 680,000 PICOs from Clinical Study Abstracts Using Generative AI: A Proof-of-Concept Study
Generative artificial intelligence (GenAI) shows promise in automating key tasks involved in conducting systematic literat...
Artificial Intelligence in Medical Affairs: A New Paradigm with Novel Opportunities
Artificial Intelligence in Medical Affairs: A New Paradigm with Novel Opportunities
The advent of artificial intelligence (AI) revolutionizes the ways of working in many areas of business and life science. ...
Evaluation of the Effectiveness of Additional Risk Minimization Measures for Ixazomib Citrate for Relapsed/Refractory Multiple Myeloma in Japan: A Web-Based Survey Among Pharmacists
Evaluation of the Effectiveness of Additional Risk Minimization Measures for Ixazomib Citrate for Relapsed/Refractory Multiple Myeloma in Japan: A Web-Based Survey Among Pharmacists
Ixazomib citrate (IXA) in combination with lenalidomide and dexamethasone (IRD therapy) has been approved for the treatmen...
P.O.L.A.R. Star: A New Framework Developed and Applied by One Mid-Sized Pharmaceutical Company to Drive Digital Transformation in R&D
P.O.L.A.R. Star: A New Framework Developed and Applied by One Mid-Sized Pharmaceutical Company to Drive Digital Transformation in R&D
Digital transformation has become a cornerstone of innovation in pharmaceutical research and development (R&D). Ph...
How Can General Managers Best Leverage Medical Affairs Now and in the Future?
How Can General Managers Best Leverage Medical Affairs Now and in the Future?
General managers (GMs) play a crucial role as enterprise leaders of the country affiliate of multi-national pharmaceutical...
Considerations for Planning Effective and Appealing Advisory Boards and Other Small-Group Meetings with Health Care Providers: Importance of Participant Preferences
Considerations for Planning Effective and Appealing Advisory Boards and Other Small-Group Meetings with Health Care Providers: Importance of Participant Preferences
To optimize cost effectiveness, engagement, reach, inclusivity, insight quality and quantity, and participant satisfaction...
Maximizing the Value of Real-World Data and Real-World Evidence to Accelerate Healthcare Transformation in China: Summary of External Advisory Committee Meetings
Maximizing the Value of Real-World Data and Real-World Evidence to Accelerate Healthcare Transformation in China: Summary of External Advisory Committee Meetings
Use of real-world data (RWD) is gaining wide attention. To bridge the gap between diverse healthcare stakeholders and to l...
Authorized or Off-Label Use? A Structured Analysis of Summaries of Product Characteristics with Regard to Authorization in Pediatrics
Authorized or Off-Label Use? A Structured Analysis of Summaries of Product Characteristics with Regard to Authorization in Pediatrics
The Summary of Product Characteristics (SmPC) is required to provide unambiguous information on the authorized use of a me...
A Sponsor’s Perspective on the Contribution of Regulatory-Required Observational Post-Marketing Studies to Understanding Human Drug Product Benefit/Risk in Japan
A Sponsor’s Perspective on the Contribution of Regulatory-Required Observational Post-Marketing Studies to Understanding Human Drug Product Benefit/Risk in Japan
Following marketing authorization in Japan, for almost all new drugs or new indications, postmarketing studies (PMS) are a...
Survey on the Situation of Medical Departments in the Pharmaceutical Industry in Spain
Survey on the Situation of Medical Departments in the Pharmaceutical Industry in Spain
Medical departments have evolved from a position of support to one of strategic leadership. The number of tasks and the co...
Advancing Rheumatology Care Through Machine Learning
Advancing Rheumatology Care Through Machine Learning
Rheumatologic diseases are marked by their complexity, involving immune-, metabolic- and mechanically mediated processes w...
Meaningful Within-Patient Change in Subjective Total Sleep Time in Patients with Insomnia Disorder: An Analysis of the Sleep Diary Questionnaire Using Data from Open-Label and Phase III Clinical Trials
Meaningful Within-Patient Change in Subjective Total Sleep Time in Patients with Insomnia Disorder: An Analysis of the Sleep Diary Questionnaire Using Data from Open-Label and Phase III Clinical Trials
The Sleep Diary Questionnaire (SDQ), a modified version of the Consensus Sleep Diary, is a 17-item sleep diary for assessi...
Physician Awareness of the Safe Use of Cyproterone Acetate in Europe: A Survey on the Effectiveness of Additional Risk Minimization Measures
Physician Awareness of the Safe Use of Cyproterone Acetate in Europe: A Survey on the Effectiveness of Additional Risk Minimization Measures
Cyproterone acetate (CPA) is a synthetic progesterone derivative introduced in the 1970s and prescribed as antiandrogenic ...
Rare Immune-Related Adverse Events (irAEs): Approach to Diagnosis and Management
Rare Immune-Related Adverse Events (irAEs): Approach to Diagnosis and Management
Immune checkpoint inhibitors (ICIs) have revolutionised the treatment landscape across many solid organ malignancies and f...
The Importance of Assessing Drug Exposure and Medication Adherence in Evaluating Investigational Medications: Ensuring Validity and Reliability of Clinical Trial Results
The Importance of Assessing Drug Exposure and Medication Adherence in Evaluating Investigational Medications: Ensuring Validity and Reliability of Clinical Trial Results
The objective of this current opinion paper is to draw global attention to medication adherence, emphasizing its crucial r...
Eliciting Exploratory Patient Preference Data: A Case Study in a Rare Disease
Eliciting Exploratory Patient Preference Data: A Case Study in a Rare Disease
Qualitative and quantitative methods provide different and complementary insights into patients’ preferences for tre...
Evaluation of Physician Knowledge of Safety and Safe Use Information for Intravitreal Aflibercept Injection in Europe: A Second Survey of Physicians Following Dissemination of Updated Risk-Minimization Materials
Evaluation of Physician Knowledge of Safety and Safe Use Information for Intravitreal Aflibercept Injection in Europe: A Second Survey of Physicians Following Dissemination of Updated Risk-Minimization Materials
Materials have been distributed in the European Union to inform physicians on the safe use of intravitreal aflibercept (IV...
The Value and Deliverables of Medical Affairs: Affiliate Perspectives and Future Expectations
The Value and Deliverables of Medical Affairs: Affiliate Perspectives and Future Expectations
The Medical Affairs (MA) function in pharmaceutical companies creates a unique opportunity to ensure the internal linkage ...
The Pharmacokinetics of Drugs Delivered to the Upper Nasal Space
The Pharmacokinetics of Drugs Delivered to the Upper Nasal Space
Pharmacokinetics (PK) includes how a drug is absorbed, distributed, metabolized and eliminated. The compartment providing ...
Journey from an Enabler to a Strategic Leader: Integration of the Medical Affairs Function in ESG Initiatives and Values
Journey from an Enabler to a Strategic Leader: Integration of the Medical Affairs Function in ESG Initiatives and Values
Like most private enterprises, the pharmaceutical industry has deeply rooted environmental, social, and governance (ESG) m...
A Survey of Industry Perceptions of Facilitated Regulatory Pathways in Drug Development in Australia
A Survey of Industry Perceptions of Facilitated Regulatory Pathways in Drug Development in Australia
In Australia, facilitated regulatory pathways (FRPs) became available with the introduction of priority review (PR) in 201...
Meaningful Within-Patient Change on the Insomnia Daytime Symptoms and Impacts Questionnaire (IDSIQ): Analysis of Phase III Clinical Trial Data of Daridorexant
Meaningful Within-Patient Change on the Insomnia Daytime Symptoms and Impacts Questionnaire (IDSIQ): Analysis of Phase III Clinical Trial Data of Daridorexant
The Insomnia Daytime Symptoms and Impacts Questionnaire (IDSIQ) is a new validated 14-item patient-reported outcome (PRO) ...
Embedding Patient-Centricity by Collaborating with Patients to Transform the Rare Disease Ecosystem
Embedding Patient-Centricity by Collaborating with Patients to Transform the Rare Disease Ecosystem
What is patient-centricity? In some contexts, it has been associated with targeting therapies based on biomarkers or enabl...
A Science-Based Methodology Framework for the Assessment of Combination Safety Risks in Clinical Trials
A Science-Based Methodology Framework for the Assessment of Combination Safety Risks in Clinical Trials
Multiple components factor into the assessment of combination safety risks when two or more novel individual products are ...
Medical Information Delivering Improved Customer Experience: A Guide
Medical Information Delivering Improved Customer Experience: A Guide
Customer experience (CX) is essential in any business. In the pharmaceutical industry, the Medical Information Contact Cen...
A Principles Framework for Digital Provision of Medical Information for Healthcare Professionals
A Principles Framework for Digital Provision of Medical Information for Healthcare Professionals
European pharmaceutical companies have a legal requirement to provide non-promotional medical information (MI) services to...
Clinical Presentations of Drug-Induced Hyperprolactinaemia: A Literature Review
Clinical Presentations of Drug-Induced Hyperprolactinaemia: A Literature Review
Screening for drug-induced hyperprolactinaemia, a condition characterised by higher-than-normal levels of serum prolactin ...
Assessing Definitions and Incentives Adopted for Innovation for Pharmaceutical Products in Five High-Income Countries: A Systematic Literature Review
Assessing Definitions and Incentives Adopted for Innovation for Pharmaceutical Products in Five High-Income Countries: A Systematic Literature Review
The concept of health care innovation varies across organizations and countries. Harmonizing the definitions of innovation...
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