Year of publication
Type of material
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Language
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Regulation of New Drug Approval in Taiwan
Online Contents | 2016|Abstract Taiwan Food and Drug Administration (TFDA) was established in 2010 as the nation’s principal consumer product protection agency of ...Publisher: Springer International Publishing, Springer Nature, [New York]Keywords: new drug approval, Taiwan Food and Drug Administration (TFDA) -
Gig Work and the Fourth Industrial Revolution: Conceptual and Regulatory Challenges
British Library Online Contents | 2018|Publisher: JOURNAL OF INTERNATIONAL AFFAIRS -
Regulatory aspects in the pharmaceutical development of nanoparticle drug delivery systems designed to cross the intestinal epithelium and M-cells
British Library Online Contents | 2016| -
Regulatory aspects in the pharmaceutical development of nanoparticle drug delivery systems designed to cross the intestinal epithelium and M-cells
British Library Online Contents | 2016| -
Report of the Council on Scientific Affairs: Unlabeled Indications of Food and Drug Administration-Approved Drugs
Online Contents | 1998|Abstract Unlabeled (also called off-label) uses are defined as the use of a drug product for indications or in patient populations, doses ...Publisher: Springer International Publishing, Sage, Thousand Oaks, Calif. -
CPI™ Certification as Predictor of Clinical Investigators’ Regulatory Compliance
Online Contents | 2012|widely accepted as it is relatively new, and thus its effectiveness as a predictor of regulatory compliance needs to be studied. ...Publisher: Springer International Publishing, Sage, Thousand Oaks, Calif.Keywords: Academy of Pharmaceutical Physicians and Investigators -
Good Statistics Practice in the Drug Development and Regulatory Approval Process
Online Contents | 1997|the process of drug development and regulatory approval. GSP provides a fair assessment of the drug product with the desired accuracy ...Publisher: Springer International Publishing, Sage, Thousand Oaks, Calif. -
Europe and the limits of international drug co‐operation
Taylor & Francis Verlag | 1997|the steps being taken to remove the European Union's internal borders. The establishment of the European Monitoring Centre for Drugs and Drug ... -
Regulatory analysis on the medical use of ephedrine-related products in Taiwan
Free accessDOAJ | 2018|to evaluate the international and Taiwan's regulatory policies and management of medical ephedrine-related products through the corresponding ... -
Editor’s Commentary: Regulatory Science and the Science of Safety
Online Contents | 2011|Publisher: Springer International Publishing, Sage, Thousand Oaks, Calif. -
Regulatory procedures in Hungary
British Library Conference Proceedings | 1994|Keywords: drug development -
Review of the 9th Middle East Regulatory Conference
Online Contents | 2011|Products in Relation to Patient SafetyBiological Medicines and Their Associated Regulatory ComplexityHarmonization of Regulatory Documentation ...Publisher: Springer International Publishing, Sage, Thousand Oaks, Calif. -
African Regulatory Conference 2010
Online Contents | 2010|Abstract The second African Regulatory Conference (ARC), which took place in Johannesburg on March 2–3, 2010, was organized by the Drug ...Publisher: Springer International Publishing, Sage, Thousand Oaks, Calif. -
Regulatory frameworks for cell therapy products in Japan
Online Contents | 2012|Abstract This paper reviews regulatory frameworks for cell therapy products in Japan. Two procedures are used to investigate the use of new ...Keywords: Pharmaceuticals affairs act, Regulatory framework -
Energy efficiency and decarbonization for container fleet in international shipping based on IMO regulatory frameworks: A case study for South Korea
Free accessDOAJ | 2023|ABSTRACTThis study investigates the impact and potential of ship’s energy efficiency and decarbonization in Korean container shipping ... -
Predictors of orphan drug approval in the European Union
Free accessOnline Contents | 2008|Objective To encourage the development of drugs for rare diseases, orphan drug legislation has been introduced in the USA (1983) and in the ...Keywords: Regulatory affairs, Drug development -
International models of ferry service delivery
Taylor & Francis Verlag | 2017|may apply tight control over markets through the acquisition of ownership or the application of regulatory schemes, or may allow for more ... -
Considerations on what constitutes a ‘qualified statistician’ in regulatory guidelines
Wiley | 2012|International regulatory guidelines require that a ‘qualified statistician’ takes responsibility for the statistical aspects of a
...Keywords: regulatory affairs -
Review of Targeted Regulatory Writing Techniques
Online Contents | 2009|Publisher: Springer International Publishing, Sage, Thousand Oaks, Calif.
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