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International journal of drug regulatory affairs : IJDRA
Free accessGWLB - Gottfried Wilhelm Leibniz Bibliothek | 1.2013 - -
Drug Regulatory Affairs
NTIS | 1988|regulations issued by the U.S. Food and Drug Administration. In order to accomplish the execution of this drug development program, the Pharmaceutical ...Keywords: Drug compounding -
Clinical research practices and drug regulatory affairs : a journal devoted to documentation of the clinical research process in the pharmaceutical industry
Catalogue medicine | 1.1983 - 8.1990/91 -
Careers in Regulatory Affairs
Wiley | 2010|such as pharmaceutical regulatory affairs (RA). RA operates at the interface of science, law, and business, applying scientific rationale along ...Publisher: Federation of American Societies for Experimental Biology -
Review of: Fundamentals of US Regulatory Affairs, 7th ed.
Online Contents | 2011|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. -
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. -
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. -
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. -
The Role of International Law in Monetary Affairs
Oxford University Press | 2010|Monetary affairs have been a stronghold of national sovereignty, and international law is poorly developed in this field, which has been ... -
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. -
Regulatory Affairs: Master of Science at San Diego State University
Wiley | 2010|regulations and policies; Interpret FDA‐related laws and regulations; Identify responsibilities of the regulatory affairs professional that extend ...Publisher: Federation of American Societies for Experimental Biology -
Regulatory Affairs as they Affect Invasive Cardiology
British Library Conference Proceedings | 2001| -
Generic drug device combination products: Regulatory and scientific considerations
British Library Online Contents | 2018| -
The Bahamas in International Affairs
Free accessDOAJ | 2008|official stance on human rights issues, South Africa, Israel, Palestine, disarmament, drug trafficking, the Organization of American States and the ...Publisher: University of the Bahamas -
Overview on Nitrogen containing compounds and their assessment based on ‘International Regulatory Standards’
Free accessBASE | 2018|various aspects of heterocyclic compounds with its biological activity & regulatory assessment based on the ‘International Regulatory Standards ...Publisher: Vinita Nagar, Society of Pharmaceutical Technocrats, 1/7756, Street no. 1, East Gorakh Park, Shahdara, Delhi, India 110032, Journal of Drug Delivery and Therapeutics (JDDT) -
2021 World of Shipping Portugal: An International Research Conference on Maritime Affairs Editorial
Free accessSpringer Verlag | 2021|selected among the ones presented at the 2021 World of Shipping Portugal, an international research conference on maritime affairs, 28–29 January ...Keywords: Future of the industry -
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. -
2022 World of shipping Portugal: an international research conference on maritime affairs
Free accessSpringer Verlag | 2023|presented at the 2022 World of Shipping Portugal Conference, An International Research Conference on Maritime Affairs, 27–28 January, that took ... -
2021 World of Shipping Portugal: An International Research Conference on Maritime Affairs Editorial
Free accessDOAJ | 2021|2021 World of Shipping Portugal, an international research conference on maritime affairs, 28–29 January 2021, that took place online from ...Keywords: Future of the industry, Shipment of goods. Delivery of goods -
International course: Clinical drug development—Scientific and regulatory strategies
National licenceLeiden, January 21–22, 1982Elsevier | 1981 -
2022 World of shipping Portugal: an international research conference on maritime affairs
Free accessDOAJ | 2023|regulatory challenges and risks whose outcome is yet to be seen. With this background, seven papers presented at the 2022 World of Shipping Portugal ...Keywords: Shipment of goods. Delivery of goods -
International Regulatory Harmonization: A New Era in Prescription Drug Approval
British Library Online Contents | 1992| -
The impact of drug-related QT prolongation on FDA regulatory decisions
British Library Online Contents | 2013| -
Chitosan-based microneedles as a potential platform for drug delivery through the skin: Trends and regulatory aspects
Elsevier | 2021|significant interest due to its ability of film-forming, biodegradability, and biocompatibility, making it suitable for topical and transdermal drug ...Keywords: Regulatory aspects -
Regulating international maritime shipping’s air polluting emissions monitoring, reporting, verifying and enforcing regulatory compliance
Free accessTaylor & Francis Verlag | 2021|are elements of current MRV&E systems that can provide building blocks for more effective regulatory systems. The conclusions are basedon a ... -
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. -
Regulatory and Drug Development Issues Related to Female Sexual Dysfunction
British Library Conference Proceedings | 2003| -
International Conference on Harmonization: Recent Reforms as a Driver of Global Regulatory Harmonization and Innovation in Medical Products
Wiley | 2019|Eight years ago, this journal published “The Value and Benefits of the International Conference on Harmonization to Drug Regulatory
... -
Local and international regulatory aspects of multicentre trials
British Library Conference Proceedings | 1994|Keywords: drug development -
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 -
The role of predictive biopharmaceutical modeling and simulation in drug development and regulatory evaluation
British Library Online Contents | 2011| -
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. -
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. -
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] -
Regulatory and operational challenges in conducting Asian International Academic Trial for expanding the indications of cancer drugs
Free accessWiley | 2021|faster and obtain new drug approval in wider areas. However, pharmaceutical regulatory differences hinder the efficient conduct of international ... -
Ketamine and international regulations
Taylor & Francis Verlag | 2017|the nonmedical use of ketamine in selected countries and its regulatory control. Methods: We conducted a review of literature ...Keywords: regulatory status -
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 -
Medical Affairs
Wiley | 2010|Keywords: Medical Affairs, Consolidated Standards of Reporting Trials (CONSORT), New Drug Application (NDA), International Committee of Medical Journal Editors (ICMJE) -
Regulatory Concerns at Various Phases of Drug Development
British Library Conference Proceedings | 1998| -
Regulatory and Quality Aspects of Herbal Drugs
Bentham Science Publishers | 2017|interaction, side effects, toxicity and adverse effects. The International Drug Monitoring Program of World Health Organization (WHO) has made certain ...Keywords: regulatory authority, drug interactions., Clinical Trials&Regulatory Affairs -
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.