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A Review of the European Community Regulatory Requirements for Expedited and Periodic ADR Reporting
Online Contents | 1997|expedited and periodic adverse drug reaction (ADR) reporting for medicinal products marketed within the EC have been effective since January 1, 1995 ...Publisher: Springer International Publishing, Sage, Thousand Oaks, Calif. -
Arrest and Detention in International Travelers
Oxford University Press | 2000|computerization services to the Department of Foreign Affairs and International Trade, Canada. The Consular Management and Operations System was designed ... -
A self‐enforcing CD44s/ZEB1 feedback loop maintains EMT and stemness properties in cancer cells
Wiley | 2015|expression. Activation of this novel CD44s‐ZEB1 regulatory loop has functional impact on tumor cells, as evident by increased tumor‐sphere initiation ...Keywords: drug resistance -
A Shift in the Regulatory Approach
Online Contents | 1998|Abstract This paper highlights the shift in the Food and Drug Administration’s (FDA) approach to the off-label use of drugs, including ...Publisher: Springer International Publishing, Sage, Thousand Oaks, Calif. -
A Snapshot of the Evolution of Pharmaceutical Regulations in China and Hong Kong
Online Contents | 2010|pharmaceutical market. Since 2001, China has introduced significant regulatory changes to strive to become compatible with international standards. These ...Publisher: Springer International Publishing, Sage, Thousand Oaks, Calif. -
Aspects of Modernizing Drug Development Using Clinical Scenario Planning and Evaluation
Online Contents | 2010|Abstract Modern drug development requires an efficient clinical development program to have a reasonable chance of successfully leading to ...Publisher: Springer International Publishing, Sage, Thousand Oaks, Calif. -
Assembling International Regulatory Submissions: A Simplified Approach
Online Contents | 1998|Abstract This paper provides a process for developing and assembling worldwide regulatory dossiers. It is based on having a regulatory ...Publisher: Springer International Publishing, Sage, Thousand Oaks, Calif. -
Assessing a Drug’s Proarrhythmic Liability: An Overview of Computer Simulation Modeling, Nonclinical Assays, and the Thorough QT/QTc Study
Online Contents | 2011|Abstract The assessment of proarrhythmic liability has assumed considerable importance in drug development. Such liability is couched in ...Publisher: Springer International Publishing, Sage, Thousand Oaks, Calif. -
Assessing Environmental Impacts of Veterinary Products: Lessons from VICH
Online Contents | 2007|Abstract In 1996, the Steering Committee of the VICH (International Cooperation on Harmonization of Technical Requirements for Registration ...Publisher: Springer International Publishing, Sage, Thousand Oaks, Calif. -
Assessing the Performance of the EMEA’s Centralized Procedure: A Comparative Analysis with the US FDA
Online Contents | 2008|period. Time from application submission to approval, as well as the effect of regulatory initiatives implemented by each regulatory body on drug ...Publisher: Springer International Publishing, Sage, Thousand Oaks, Calif. -
Assessment of Generic Drugs in the Caribbean
Online Contents | 1998|and Tobago the Minstry of Health is drafting a national drug policy which will address evaluation of generic substitutes. Concerns about the ...Publisher: Springer International Publishing, Sage, Thousand Oaks, Calif. -
Assessment of sulphonamides and tetracyclines antibiotic residue contaminants in rural and peri urban dairy value chains in Kenya
Free accessSpringer Verlag | 2017|been used for the treatment of animal diseases. These residues have the ability to expose the public to serious health hazards. In Kenya drug ...Publisher: Springer International Publishing, Cham -
Association Between Pulmonary Hypertension and Transcatheter Aortic Valve Replacement: Analysis of a Nationwide Inpatient Sample Database
Bentham Science Publishers | 2019|patients who were hospitalized with a primary/secondary diagnosis of TAVR as specified by International Classification of Disease (ICD-9) codes ...Keywords: Clinical Trials & Regulatory Affairs, Drug Design and Discovery, Drug Design, Discovery & Therapy, Drug Therapy -
A Standard Computable Clinical Trial Protocol: The Role of the BRIDG Model
Online Contents | 2007|protocol lies at the heart of these operations, making it a prime candidate for the benefits afforded by computer processing. With a vision to ...Publisher: Springer International Publishing, Sage, Thousand Oaks, Calif. -
A Statistically-Based Process for Auditing Clinical Data Listings
Online Contents | 1997|process for clinical data listings. With the advent of the International Conference on Harmonization (ICH) good clinical practices (GCPs), they ...Publisher: Springer International Publishing, Sage, Thousand Oaks, Calif. -
A Study of Trends in Pharmaceutical Regulatory Approval Times for Nine Major Markets in the 1990s
Online Contents | 1998|Abstract Before reaching the market, the last stage of development through which a new pharmaceutical compound must pass is regulatory ...Publisher: Springer International Publishing, Sage, Thousand Oaks, Calif. -
A Study on the Consistency Between Flagging by Statistical Tests and Biological Evaluation
Online Contents | 2000|repeated dose toxicity studies in the rat. Raw data of quantitative parameters of 19 regulatory toxicity studies were collected with their final ...Publisher: Springer International Publishing, Sage, Thousand Oaks, Calif. -
Asymmetric-flow field-flow fractionation for measuring particle size, drug loading and (in)stability of nanopharmaceuticals. The joint view of European Union Nanomedicine Characterization Laboratory and National Cancer Institute - Nanotechnology Characterization Laboratory
Free accessBASE | 2020|, polydispersity, drug loading and stability of nanopharmaceuticals. However, the application of robust and high quality standard operating procedures ...Keywords: regulatory framework -
Asymmetric-flow field-flow fractionation for measuring particle size, drug loading and (in)stability of nanopharmaceuticals. The joint view of European Union Nanomedicine Characterization Laboratory and National Cancer Institute - Nanotechnology Characterization Laboratory
Free accessBASE | 2021|, polydispersity, drug loading and stability of nanopharmaceuticals. However, the application of robust and high quality standard operating procedures ...Keywords: regulatory framework -
A Systems Infrastructure for Sponsor/CRO Collaboration on International Clinical Trials
Online Contents | 1998|on international Phase III clinical trials. With the goal of speeding up the clinical development process, information technology is being ...Publisher: Springer International Publishing, Sage, Thousand Oaks, Calif.
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