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A Primer on Bioterrorism: Potential Pathogens, Roles of United States Governmental Agencies, and Regulatory Models for Product Development
Online Contents | 2003|bioterrorism. The Food and Drug Administration (FDA), in particular, may need to develop new regulatory models that will allow expeditious approval of ...Publisher: Springer International Publishing, Sage, Thousand Oaks, Calif. -
A Primer on CBER’s Regulatory Review Structure and Process
Online Contents | 1998|. As technology and medical research move forward in the development of novel biological products to aid in this endeavor, regulatory affairs ...Publisher: Springer International Publishing, Sage, Thousand Oaks, Calif. -
A Quality Management System for Pharmacovigilance Activities
Online Contents | 2000|Abstract Pharmacovigilance is an area of drug development that is increasingly found in the regulatory spotlight. As a result, companies ...Publisher: Springer International Publishing, Sage, Thousand Oaks, Calif. -
A quantitative approach of using genetic algorithm in designing a probability scoring system of an adverse drug reaction assessment system
Elsevier | 2007|adverse drug reactions (ADRs) are well established. Hence, precise and accurate assessment of ADRs’ causality which can differentiate signal from ... -
A Regulatory Perspective on Validation of Surrogate Endpoints
Online Contents | 2007|the critical path of drug development. During the 41st DIA Annual Meeting in Washington, DC, Dr. Lawrence Lesko from the Office of Clinical ...Publisher: Springer International Publishing, Sage, Thousand Oaks, Calif. -
Are Pharmaceutical Market Withdrawals Preventable? A Preliminary Analysis
Online Contents | 2012|marketing. Therefore, there is a desire to minimize drug withdrawals by learning from previous incidents. Hints of the problems that lead to ...Publisher: Springer International Publishing, Sage, Thousand Oaks, Calif.Keywords: drug safety, regulatory affairs -
A research agenda for moving early medical pregnancy termination over the counter
Wiley | 2017|mifepristone–misoprostol regimen for medical termination at ≤10 weeks of gestation meet US Food and Drug Administration regulatory criteria ...Keywords: medical termination of pregnancy -
A Review and Analysis of Key Regulations and Guidelines Concerning the Safety Sections of the Investigator’s Brochure
Online Contents | 2001|Abstract Recent regulatory initiatives and consensus documents have altered the conventional approach to evaluating and communicating ...Publisher: Springer International Publishing, Sage, Thousand Oaks, Calif. -
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
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