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Review of: Fundamentals of US Regulatory Affairs, 7th ed.
Online Contents | 2011|Publisher: Springer International Publishing, Sage, Thousand Oaks, Calif. -
A Comparison of the Drug Review Process at Five International Regulatory Agencies
Online Contents | 2007|Abstract Regulatory approval time is a key metric that is used to evaluate the performance of regulatory agencies. A new methodology has ...Publisher: Springer International Publishing, Sage, Thousand Oaks, Calif. -
Review of Pharmaceutical Competitive Intelligence for the Regulatory Affairs Professional
Online Contents | 2012|Publisher: Springer International Publishing, Sage, Thousand Oaks, Calif. -
Drug Metabolism in Drug Development: A DIA Tutorial for Regulatory Affairs Specialists
Online Contents | 1998|information to the overall drug development campaign. The purpose of the tutorial described here was to allow regulatory affairs specialists to gain a ...Publisher: Springer International Publishing, Sage, Thousand Oaks, Calif. -
Guest Editor’s Note: Regulatory Affairs
Online Contents | 2002|Publisher: Springer International Publishing, Sage, Thousand Oaks, Calif. -
Interim Analysis: What Regulatory Affairs Professionals Need to Know
Online Contents | 2010|under an Investigational New Drug Application. Herein, I review the types of trials that may benefit from DMC involvement and provide an example ...Publisher: Springer International Publishing, Sage, Thousand Oaks, Calif. -
The Regulatory Affairs Professional in the “Hot Seat” in the Drug Development Process
Online Contents | 1997|Abstract The role of regulatory affairs in the drug development process must and has expanded to meet the goals of quicker and more ...Publisher: Springer International Publishing, Sage, Thousand Oaks, Calif. -
Global and Regional Drug Regulatory Harmonization Initiatives
Online Contents | 2010|Abstract The diversity of pharmaceutical regulatory requirements makes marketing new drugs a very complex and costly process that delays ...Publisher: Springer International Publishing, Sage, Thousand Oaks, Calif. -
Current Drug Regulatory Status of Advanced Drug Evaluation System in Korea
Online Contents | 2009|and changing lifestyles. Drug products are important for the prevention, diagnosis, and treatment of diseases, and the development of drug ...Publisher: Springer International Publishing, Sage, Thousand Oaks, Calif. -
Guest Editors’ Note: Special Issue on Regulatory Affairs
Online Contents | 2000|Publisher: Springer International Publishing, Sage, Thousand Oaks, Calif. -
An Experimental Model of Regulatory Science in Asia: Center for Drug Evaluation in Taiwan
Online Contents | 2009|application, and health technology assessment delegated by the legal regulatory authority, the Bureau of Pharmaceutical Affairs (BPA). Over the last ...Publisher: Springer International Publishing, Sage, Thousand Oaks, Calif. -
Methods and strategies for assessing uncontrolled drug–drug interactions in population pharmacokinetic analyses: results from the International Society of Pharmacometrics (ISOP) Working Group
Online Contents | 2016|-academia-regulatory collaboration. It is the recommendation of the working group that greater focus be given to the analysis of uncontrolled ...Keywords: Drug interactions -
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. -
Understanding the Interfaces Among Multiple Technical Disciplines: An Increasing Challenge for Regulatory Affairs
Online Contents | 1998|regulatory affairs professionals is to assure that an integrated, coherent, and nonconflicting set of information is developed across different ...Publisher: Springer International Publishing, Sage, Thousand Oaks, Calif. -
Exploring Best Practices on Development Regulatory Affairs and Clinical Development Related to Multiregional Clinical Trials (MRCTs) in China, Korea, and Taiwan
Online Contents | 2013|practices for development regulatory affairs and clinical development related to multiregional clinical trials (MRCTs) in China, Korea and Taiwan. I ...Publisher: Springer International Publishing, Springer Nature, [New York] -
Statistics and Statisticians in European Drug Regulatory Agencies
Online Contents | 1998|and statistical review procedures was sent to the director of the national drug regulatory agency in each of 18 European countries (current ...Publisher: Springer International Publishing, Sage, Thousand Oaks, Calif. -
Experts’ Views on FDA Regulatory Standards for Drug and High-Risk Medical Devices: Implications for Patient Care
Online Contents | 2022|evidence. Main Measures Principal themes in 3 domains: expedited regulatory pathways, physician and patient understanding of and reliance on FDA ...Publisher: Springer International Publishing, Springer, New York, NY -
Comparison of Drug Approvals in Europe Versus the United States
Online Contents | 2014|Background Regulators from the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) do not always agree on ...Publisher: Springer International Publishing, Springer Nature, [New York]Keywords: drug approval, regulatory affairs -
International Conference on Harmonization-Keeping International Drug Development in Harmony?
Online Contents | 2001|Abstract Back in the beginning of the 1990s the International Conference on Harmonization (ICH) was born with the objective of achieving ...Publisher: Springer International Publishing, Sage, Thousand Oaks, Calif. -
An Overview of the US Regulatory Environment for Drug-Device and Biologic-Device Combination Products
Online Contents | 2006|initiatives and regulations that try to clarify the issues and regulatory status of this growing class of medical products. ...Publisher: Springer International Publishing, Sage, Thousand Oaks, Calif.
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