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Survey of Health Care Practitioners’ Preferences for Medical Information: Collective Insights for Impacting Patient Care
BackgroundMedical information (MI) departments play an integral role in providing fair and scientifically balanced MI to health care professionals,...
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Ergebnisse des AMNOG-Erstattungsbetragsverfahrens
Das mit dem Arzneimittelmarktneuordnungsgesetz (AMNOG) eingeführte Regulierungsverfahren für neue patentgeschützte Arzneimittel ist insgesamt positiv...
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Pharmaceutical Policy in Brazil
Brazil’s pharmaceutical policies have undergone significant changes in recent decades resulting in improved access, surveillance, and support for...
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Pharmaceutical Policy in the Philippines
The Philippines has a large and well-developed pharmaceutical sector with a focus on production of generic medicines. Pharmaceutical regulation...
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Evaluation of Safety Profiles of Blood Cancer Drugs Approved in Japan
BackgroundIn drug development, the safety of a test drug for human use is first assessed in animal toxicology studies; therefore, the...
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Quality of Regulatory Decision-Making Practices: Issues Facing Companies and Agencies
BackgroundThe science of decision making is well established, although in reality it is a mixture of science and art. What is currently lacking is...
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Pharmaceutical Pricing and Reimbursement in Japan: For Faster, More Complete Access to New Drugs
BackgroundIn Japan, National Health Insurance (NHI) has ensured that all Japanese citizens can use the health services they need for more than 50...
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Modern Approaches to Estimating the Content of Genotoxic Impurities in Drugs (a Review)
This review considered international approaches to assessment of the content of genotoxic impurities (residual solvents and various inorganic and...
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An Evaluation of the Efficiency of the Gulf Cooperation Council’s Centralized Procedure by the Gulf Regulatory Authorities and Pharmaceutical Companies: Recommendations for an Improved Model
The aim of this study was to examine the views and experiences of the Gulf Cooperation Council (GCC) states and pharmaceutical companies to identify...
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An Overview and Analysis Regarding the Use of Adjudication Methods in EU and US Drug Approvals
BackgroundSeveral regulatory guidelines recommend that assessments of endpoints supporting drug approval should be verifiable by applicants and the...
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Zulassungsverfahren für neue Arzneimittel in Europa
Die Zulassung neuer Humanarzneimittel wird in Europa durch die Richtlinie 2001/83/EC sowie verschiedene Verordnungen der Europäischen Gemeinschaft...
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Evaluation of the Gulf Cooperation Council Centralized Procedure: The Way Forward
The aim of the study was to evaluate the Gulf Cooperation Council (GCC) centralized regulatory review process. Regulatory review times-including...
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APEC Workshop Report of Good Review Practices on Medical Products
As part of the implementation of the 2020 Good Review Practices (GRevP) Roadmap championed by Chinese Taipei in the Asia-Pacific Economic Cooperation...
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Statistics, Quality Review Issues, and Beyond for Generic Drug Applications in Taiwan
The aim of the present study was to investigate the characteristics and deficiencies listed in the final quality assessment reports of generic drug...
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Current Trends in Personalized Medicine and Companion Diagnostics: A Summary From the DIA Meeting on Personalized Medicine and Companion Diagnostics
Personalized medicine has reached the mainstream, accounting for more new drug approvals and a promising pipeline of candidate therapeutics. Recent...
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How Should a Globalized CTD Be Created? An Introduction to the Japanese 3-Layer Approach
This article is based on the consensus of a task force of the Data Science Expert Committee, Japan Pharmaceutical Manufacturers Association. Common...
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Product Design
Pharmaceutical companies, hospital and community pharmacies prepare medicines. Although batch sizes vary greatly, the underlying principles of...
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A Universal Framework for the Benefit-Risk Assessment of Medicines: Is This the Way Forward?
A universal framework for the evaluation of the benefit-risk assessment of medicines during development by pharmaceutical companies and in the...
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ICH: Strengths, Weaknesses, and Future Tasks
The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) started in 1990 with...
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Pharmaceutical Quality Systems
A quality management system (QMS) is an important tool for process control and continual improvement. After a brief section about development of the...