Year of publication
Type of media
Subject
Type of material
Licence
Language
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3‐OH flavone inhibition of epidermal growth factor‐induced proliferaton through blocking prostaglandin E2 production
Wiley | 2004|, however, the role of prostaglandin E2 (PGE2) plays in EGF‐induced proliferation in still unclear. EGF and PGE2 ...Keywords: extracellular regulatory kinases -
5th Middle East Regulatory Conference
Online Contents | 2003|Abstract In this article, the conference organizers capture the key proceedings and outcomes of the meeting, including details of the ...Publisher: Springer International Publishing, Sage, Thousand Oaks, Calif. -
6th Middle East Regulatory Conference (MERC): Key Proceedings
Online Contents | 2005|of intellectual property rights/data protection, Gulf Central Committee for Drug Registration (GCC-DR) update, the International Conference ...Publisher: Springer International Publishing, Sage, Thousand Oaks, Calif. -
7th Middle East Regulatory Conference (MERC)
Online Contents | 2007|Abstract The 7th Middle East Regulatory Conference (MERC), hosted by the Ministry of Health, the United Arab Emirates, took place in Dubai ...Publisher: Springer International Publishing, Sage, Thousand Oaks, Calif. -
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. -
10th international symposium on the synthesis and applications of isotopes and isotopically labelled compounds—WBA–new methods and applications and WBA–instrumentation and regulatory, Sessions 5 & 6: Monday, June 15, 2009
Wiley | 2010|Predicting human radiation Dosimetry for clinical radiolabelled drug development studies was discussed
... -
2010: Year in Review
Wiley | 2011|, three‐way crossover study in migraine patients, treated with 2 doses of BGC20‐1531 and placebo BTG International ... -
Accelerating investigation of new HIV drugs in pregnancy: advancing the research agenda from theory to action
Free accessWiley | 2022|treatment and prevention of HIV have led to unacceptable delays in the generation of data to support optimal antiretroviral drug use in pregnancy ... -
Access to essential drugs in Guyana: a public health challenge
Wiley | 2010|barriers to drug access include: (1) lack of national drug policy and regulation, and limited role of the regulatory authority; (2) inefficient ...Keywords: drug access, drug policy -
Accurate prediction and elucidation of drug resistance based on the robust and reproducible chemoresponse communities
Wiley | 2018|potential regulatory mechanism, such as dysregulation of cancer cell apoptosis or disturbance of drug metabolism. Moreover, compounds were linked ...Keywords: drug resistance, transcription factor and miRNA regulatory network -
Acetaminophen and/or antibiotic use in early life and the development of childhood allergic diseases
Oxford University Press | 2013|diseases (atopic dermatitis, asthma and allergic rhinitis) in the 1998 birth cohort, but the observed relationship of drug exposure in the 2003 ... -
Achieving orphan designation for placental insufficiency: annual incidence estimations in Europe
Wiley | 2019|To determine whether a novel therapy for placental insufficiency could achieve orphan drug status by
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A Cluster-Randomized Clinical Trial to Decrease Prescription Opioid Misuse: Improving the Safety of Opioid Therapy (ISOT)
Online Contents | 2022|prescription opioid misuse (Current Opioid Misuse Measure) and urine drug test results. Secondary outcomes were quality of the clinician-patient ...Publisher: Springer International Publishing, Springer, New York, NY -
A Comparative Study of the Communication of Drug Safety Information by Governmental Agencies in Japan and Western Countries: The Case of Asthma Medications
Online Contents | 2008|important to evaluate whether the communication of DSI issued by regulatory agencies is adequate. We investigated DSI communicated through the ...Publisher: Springer International Publishing, Sage, Thousand Oaks, Calif. -
A comparison of molecular representations for lipophilicity quantitative structure–property relationships with results from the SAMPL6 logP Prediction Challenge
Springer Verlag | 2020|Effective representation of a molecule is required to develop useful quantitative structure–property
...Publisher: Springer International Publishing, Cham -
A comparison of new drugs approved by the FDA, the EMA, and Swissmedic: an assessment of the international harmonization of drugs
Online Contents | 2018|three regulatory agencies. Despite international drug regulation harmonization efforts, significant differences in the characteristics of new ...Keywords: Drug labeling, Drug approval, US Food and Drug Administration -
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. -
A Contract Research Organization's Challenge: Validating Cutting-Edge Software for Imaging in Clinical Studies
Online Contents | 2010|the medical imaging workstations used in clinical investigations must be validated prior to data collection in support of a regulatory ...Publisher: Springer International Publishing, Sage, Thousand Oaks, Calif. -
Adaptive Design and Decision Analysis—Companions for Transforming Clinical Development
Online Contents | 2008|of drug development. In the arena of clinical trial methodologies, adaptive designs have received much recent attention, holding considerable ...Publisher: Springer International Publishing, Sage, Thousand Oaks, Calif. -
A Data-Driven Approach to Risk-Based Source Data Verification
Online Contents | 2014|published in the Drug Information Journal that proposed 4 hypothetical risk-based monitoring approaches. The paper’s authors proposed well-thought ...Publisher: Springer International Publishing, Springer Nature, [New York] -
Additional safety risk to exceptionally approved drugs in Europe?
Wiley | 2011|drug approval increases the risk of serious safety issues emerging after market approval. ...Keywords: regulatory affairs, drug safety, licensing of drugs -
Adherence of safety information on over‐the‐counter product labels and leaflets to the regulatory guidelines in Malaysia
Wiley | 2018|‐counter (OTC) product labels and patient information leaflets (PILs) to the Malaysian and international regulatory guidelines ...Keywords: drug safety -
Adjustment of Treatment Effect for Covariates in Clinical Trials: Statistical and Regulatory Issues
Online Contents | 2000|adjustment of treatment effects for the influence of covariates and discuss some statistical and regulatory issues on the applications of these ...Publisher: Springer International Publishing, Sage, Thousand Oaks, Calif. -
Advances in Pharmaceutical Market Integration in Mercosur and Other Latin American Countries
Online Contents | 1998|registration of products. This will strengthen national regulatory systems and consumer protection. The harmonization process will strive to reach ...Publisher: Springer International Publishing, Sage, Thousand Oaks, Calif. -
Adverse Event Analysis and MedDRA: Business as Usual or Challenge?
Online Contents | 2005|Abstract The Medical Dictionary for Regulatory Activities (MedDRA) is a dictionary of medical terms which covers signs and symptoms ...Publisher: Springer International Publishing, Sage, Thousand Oaks, Calif. -
Adverse Event Reporting and Standardized Medical Terminologies: Strengths and Limitations
Online Contents | 2002|Abstract The International Conference on Harmonization (ICH) is a unique multinational effort involving globalization of the pharmaceutical ...Publisher: Springer International Publishing, Sage, Thousand Oaks, Calif. -
Adverse Experience Reporting for OTC Medicines: Scientific/Regulatory Framework and Review of a Hypothetical Case Study
Online Contents | 2004|Abstract Adverse experience reports have been a vital aspect of postmarketing surveillance for all drug products, including those marketed ...Publisher: Springer International Publishing, Sage, Thousand Oaks, Calif. -
Adverse immunostimulation caused by impurities: The dark side of biopharmaceuticals
Wiley | 2019|Drug safety is an important issue, especially in the experimental phases of development. Adverse immunostimulation (AI) is sometimes
...Keywords: drug safety, adverse drug reactions -
Adverse Reaction Signaling and Disproportionality Analysis: An Update
Online Contents | 2012|databases to meet the evolving regulatory mandates. The basic elements of signaling require an understanding of the different signaling methods ...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. -
A Fully Bayesian Approach to Calculating Sample Sizes for Clinical Trials with Binary Responses
Online Contents | 2002|under consideration minus the cost of the trial. The regulatory requirements for granting a licence to the new treatment are discussed. It is ...Publisher: Springer International Publishing, Sage, Thousand Oaks, Calif. -
A genetic variant in a PP2A regulatory subunit encoded by the PPP2R2B gene associates with altered breast cancer risk and recurrence
Wiley | 2011|., Nat Rev Drug Discov 2008;7:979‐87). This gene encodes a regulatory subunit of protein phosphatase 2A (PP2A), one of the major Ser/Thr ... -
A history of antimicrobial drugs in animals: Evolution and revolution
Wiley | 2021|The evolutionary process of antimicrobial drug (AMD) uses in animals over a mere eight decades (1940–2020) has
... -
A manifesto for clinical pharmacology from principles to practice
Wiley | 2010|pharmacologists are employed by universities, health‐care services, private organizations (such as drug companies), and regulatory agencies. They are ... -
A Meta-analysis to Assess the FDA DAVP’s TLOVR Algorithm in HIV Submissions
Online Contents | 2011|Abstract The first meta-analysis of pivotal HIV study results utilizing data from 18 clinical trials involving seven NDAs with 8,046 ...Publisher: Springer International Publishing, Sage, Thousand Oaks, Calif. -
Analgesic use, blood dyscrasias, and case-control pharmacoepidemiology
National licenceA critique of the International Agranulocytosis and Aplastic Anemia StudyElsevier | 1987|a conceptual framework for examining the goal, methods, and analysis of an epidemiologic study of drug risks and review the IAAAS within ... -
Analysis of safety reporting requirements during medical device clinical trials in Japan
Online Contents | 2013|drug and medical devices in Japan with the international guidelines International Conference on Harmonization (ICH)-E2A/E2F and GHTF/SG5/N5. As ...Keywords: Regulatory -
Analytical Support for Drug Manufacturing in the United States’From Active Pharmaceutical Ingredient Synthesis to Drug Product Shelf Life
Online Contents | 2003|development and approval, through manufacturing and shelf life of the drug product. Key elements of analytical support to manufacturing that are ...Publisher: Springer International Publishing, Sage, Thousand Oaks, Calif. -
An Appraisal of Good Regulatory Review Practices in the Gulf Cooperation Council States
Online Contents | 2012|Abstract The aim of this study was to evaluate how each Gulf Cooperation Council (GCC) regulatory authority is building quality into the ...Publisher: Springer International Publishing, Sage, Thousand Oaks, Calif.Keywords: regulatory review -
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. -
An Historical Perspective of the Successful Development of Sevoflurane
Online Contents | 1998|markets rapidly. Prior to entry, regulatory review and approval of a market application is required in each country. This overview chronicles the ...Publisher: Springer International Publishing, Sage, Thousand Oaks, Calif. -
An Institutional Program to Increase Compliance with Clinicaltrials.gov Requirements
Online Contents | 2019|clinicaltrials.gov beyond the requirements of the Food and Drug Administration Amendments Act of 2007. The International Committee of Medical Journal Editors ...Publisher: Springer International Publishing, Springer Nature, [New York] -
An Integrated Approach to the Preparation of Global CMC Dossiers
Online Contents | 1997|managerial staffs in research, project planning, regulatory affairs, manufacturing, marketing, quality assurance, and information management work ...Publisher: Springer International Publishing, Sage, Thousand Oaks, Calif. -
An Integrated Bioinformatics and Quantitative Modeling Approach to Investigate Potential Claims of Oral Generic Drug Product Bioinequivalence: Introduction
Wiley | 2019|Keywords: Regulatory/Scientific Affairs (REG) -
A Noninferiority Test for Treatment-by-Factor Interaction with Application to Bridging Studies and Global Trials
Online Contents | 2009|factors is important not only to regulatory agencies in the approval of the drug but also to the public health. Examples include bridging studies ...Publisher: Springer International Publishing, Sage, Thousand Oaks, Calif. -
A novel role for placental leucine aminopeptidase (P‐LAP) as a determinant of chemoresistance in endometrial carcinoma cells
Wiley | 2006|apoptosis regulatory proteins as a mechanism of drug resistance. We transfected P‐LAP cDNA into A‐MEC cells (endometrial adenocarcinoma cell line ... -
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. -
Antibiotic resistance--action to promote new technologies: report of an EU Intergovernmental Conference held in Birmingham, UK, 12-13 December 2005
Oxford University Press | 2006|deliver the new drugs, diagnostics and vaccines.- Modifications to the international regulatory requirements for drug licensing could
... -
Anticancer drugs that target metabolism: Is dichloroacetate the new paradigm?
Wiley | 2011|important for tumor growth are being touted as novel targets for anticancer drug development. One of the candidates in this class of drugs being ... -
Anticoagulation in atrial fibrillation: NOAC prescribing in primary health care
Online Contents | 2017|Abstract Background Few studies assess the use of non-vitamin K antagonist oral anticoagulants (NOACs) in daily practice for the prevention ...Publisher: Springer International Publishing, Springer, Dordrecht [u.a.]Keywords: Drug utilization
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