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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. -
Actions in response to drug safety signals arising from a spontaneous reporting system: Retrospective study in The Netherlands
IOS Press | 2016|close collaboration with the Dutch regulatory agency, the Medicines Evaluation Board (MEB).OBJECTIVE: The objective of this
...Keywords: Adverse drug reactions (ADRs), post marketing drug safety -
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 Drug Reaction Labelling for Atomoxetine, Methylphenidate and Modafinil: Comparison of Product Information for Oral Formulations in Australia, Denmark and the United States
Bentham Science Publishers | 2013|labelling for different therapeutic categories in different countries and detected large variations in a number of reported adverse drug reactions ...Keywords: Adverse drug reaction, international comparison, summary of product characteristics., Clinical Trials & Regulatory Affairs, Drug Design and Discovery -
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 ...
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