Year of publication
Type of material
Licence
Language
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Medical Affairs and Drug Information Practices Within the Pharmaceutical Industry: Results of a Benchmarking Survey
Online Contents | 1999|party devised and conducted a medical affairs drug information benchmarking survey over a two-month period beginning in December of 1997. This ...Publisher: Springer International Publishing, Sage, Thousand Oaks, Calif. -
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. -
Second IFPMA Asian Regulatory Conference: Harmonisation between Asian regulatory authorities and industry
British Library Conference Proceedings | 1999|Publisher: Regulatory Affairs Journal Ltd -
EU pharmacovigilance regulatory requirements of anticancer biosimilar monoclonal antibodies
Free accessOnline Contents | 2018|Abstract An increasing number of innovative oncology monoclonal antibodies (mAbs) have been introduced into the global market, and ...Publisher: Springer International Publishing, Springer, Dordrecht [u.a.]Keywords: Adverse drug reaction -
Roles of Regulatory Project Managers in the U.S. Food and Drug Administration’s Center for Drug Evaluation and Research
Online Contents | 2000|Research’s new drug review process was clearly the springboard for the evolution of the regulatory project manager position. This role represents a ...Publisher: Springer International Publishing, Sage, Thousand Oaks, Calif. -
Organization and Responsibilities of the Chemistry, Manufacturing, and Controls Function within Regulatory Affairs: A Survey of 17 Companies
Online Contents | 1998|Abstract To facilitate management of the technical and regulatory Chemistry Manufacturing and Controls (CMC) issues within core dossiers ...Publisher: Springer International Publishing, Sage, Thousand Oaks, Calif. -
Clinical Development of Biologics Approved by the US Food and Drug Administration, 2003-2016
Online Contents | 2019|Center for Drug Evaluation and Research (FDA CDER) between 2003 and 2016. Methods We conducted a retrospective analysis of publicly available ...Publisher: Springer International Publishing, Springer Nature, [New York]Keywords: drug approval, regulatory Affairs -
Regulatory regionalism and anti-money-laundering governance in Asia
Taylor & Francis Verlag | 2015|within a regional governance regime. Second, although this form of regulatory regionalism is established in order to bypass the perceived ...Keywords: regulatory regionalism -
Energy efficiency and decarbonization for container fleet in international shipping based on IMO regulatory frameworks: A case study for South Korea
Free accessTaylor & Francis Verlag | 2023|This study investigates the impact and potential of ship’s energy efficiency and decarbonization in
... -
Gig Work and the Fourth Industrial Revolution: Conceptual and Regulatory Challenges
British Library Online Contents | 2018|Publisher: JOURNAL OF INTERNATIONAL AFFAIRS -
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) -
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. -
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 procedures in Hungary
British Library Conference Proceedings | 1994|Keywords: drug development -
Review of Targeted Regulatory Writing Techniques
Online Contents | 2009|Publisher: Springer International Publishing, Sage, Thousand Oaks, Calif. -
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 -
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 ... -
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 ... -
Biosimilars: A Regulatory Review
Online Contents | 2008|Abstract This article summarizes the regulatory situation of biosimilar medicinal products from their first appearance to the recent ...Publisher: Springer International Publishing, Sage, Thousand Oaks, Calif. -
A Model of Controlled Release of Polymer-dispersed Drug Systems Containing Regulatory Particles
Online Contents | 2001| -
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 -
Quality, Safety, and Efficacy of Herbal Products through Regulatory Harmonization
Online Contents | 2011|mainly depends on regulatory requirements of respective countries. To probe the role of regulatory standards and their harmonization in improving ...Publisher: Springer International Publishing, Sage, Thousand Oaks, Calif. -
Initiatives to Speed New Drug Development and Regulatory Review: The Impact of FDA-Sponsor Conferences
Online Contents | 1997|Abstract Survey data were used to examine the effects that various factors may have on the length of the new drug development and approval ...Publisher: Springer International Publishing, Sage, Thousand Oaks, Calif. -
Rationale for Drug Development of Herbals in Oncology: Clinical, Industry, and Regulatory Perspectives
Online Contents | 1999|Abstract An estimated 42% of Americans use complementary/alternative medicine (CAM) and some 50% of cancer patients routinely combine them ...Publisher: Springer International Publishing, Sage, Thousand Oaks, Calif. -
Quality specifications for peptide drugs: a regulatory‐pharmaceutical approach
Wiley | 2009|(i.e. quality attributes, procedures and acceptance criteria) as part of their quality assurance to ensure the safety and efficacy of drug ...Keywords: regulatory affairs, peptide drug substance -
Regulatory and Clinical Trial Systems in Japan
Wiley | 2013|systems; to eradicate drug‐lag, ensure that Japan is in line with international standards, expand its participation in the global development of ...Keywords: regulatory system, drug‐lag -
Enhancing the Clinical Professional’s Knowledge of Regulatory Documents
Online Contents | 2011|Abstract The author, an experienced freelance regulatory writer for the pharmaceutical industry, describes her experience contributing to ...Publisher: Springer International Publishing, Sage, Thousand Oaks, Calif. -
New Approaches to Regulatory Innovation Emerging During the Crucible of COVID-19
Online Contents | 2020|Regulatory Affairs at Bayer AG, examines how impacts of the COVID-19 crisis will continue beyond the pandemic period to the benefit of patients, drug ...Publisher: Springer International Publishing, Springer Nature, [New York]Keywords: Regulatory policy -
The regulatory and policy variables influencing FDI in South Africa
Wiley | 2022|country, and international and local entrepreneurs prosper as the ease of doing business improves. South Africa does not have a complex regulatory ... -
Role of the U.S. Food and Drug Administration in the Regulatory Management of Human Listeriosis in the United States
British Library Online Contents | 2008|Publisher: INTERNATIONAL ASSOCIATION FOR FOOD PROTECTION -
Pharmacogenetics of warfarin: regulatory, scientific, and clinical issues
Online Contents | 2007|warfarin dose, pharmacogenetics-based therapy may improve the safety of anticoagulant therapy. To improve drug safety, the FDA updates labels of ... -
Impact of Different Regulatory Requirements for Trial Endpoints in Multiregional Clinical Trials
Online Contents | 2011|Abstract Regulatory agencies in different parts of the world may have different requirements for end-points, which significantly affects ...Publisher: Springer International Publishing, Sage, Thousand Oaks, Calif. -
Antibody-Drug Conjugates: The New Frontier of Chemotherapy
Free accessDOAJ | 2020|In recent years, antibody-drug conjugates (ADCs) have become promising antitumor agents to be used as one of the tools in personalized ...Keywords: Antibody-Drug Conjugate, drug targeting -
Potential Use of DNA Barcodes in Regulatory Science: Identification of U.S. Food and Drug Administration's ``Dirty 22,'' Contributors to the Spread of Foodborne Pathogens
British Library Online Contents | 2013|Publisher: INTERNATIONAL ASSOCIATION FOR FOOD PROTECTION -
Editor’s Commentary: A New Category of Articles— Regulatory Commentaries
Online Contents | 2012|Publisher: Springer International Publishing, Sage, Thousand Oaks, Calif. -
Regulatory toxicology considerations for the development of inhaled pharmaceuticals
British Library Online Contents | 2013| -
8th Middle East Regulatory Conference
Online Contents | 2009|Abstract The 8th Middle East Regulatory Conference (MERC), organized by the Drug Information Association (DIA), was held in Bahrain on ...Publisher: Springer International Publishing, Sage, Thousand Oaks, Calif. -
Regulatory toxicology considerations for the development of inhaled pharmaceuticals
British Library Online Contents | 2013| -
The Role of Disproportionality Analysis of Pharmacovigilance Databases in Safety Regulatory Actions: a Systematic Review
Bentham Science Publishers | 2015|Introduction: Disproportionality analysis (DA) of adverse drug reactions spontaneous reporting (SR) databases is used to identify signals ...Keywords: Adverse drug reactions, regulatory actions., Clinical Trials & Regulatory Affairs, Drug Design and Discovery
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