Year of publication
Subject
Type of material
Licence
Language
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Women in prison: Responses of European prison systems to problematic drug users
Emerald Group Publishing | 2005|Problematic drug use in prison remains a pervasive and increasing concern throughout the European Union (EU) in terms of costs to the
...Keywords: Problematic drug use -
Will Data Privacy Impact Health Research?
Online Contents | 2002|regulatory framework in the European Union and has the potential to impact the use of human data generated during product development or ...Publisher: Springer International Publishing, Sage, Thousand Oaks, Calif. -
Why Are Some Meta-Analyses More Credible Than Others?
Online Contents | 2001|comparison of, for example, two drugs for the same indication. Presently, meta-analysis is considered to be of only minor importance in the new drug ...Publisher: Springer International Publishing, Sage, Thousand Oaks, Calif. -
Who Advises the Data Monitoring Committee (DMC)? A Review of Regulatory Guidance for Sponsors on DMCs After 5 Years and Advice for DMC Members
Online Contents | 2012|applicability of guidance to sponsors after 5 years and suggests that regulatory support for DMC members would be valuable. Advice is offered to members ...Publisher: Springer International Publishing, Sage, Thousand Oaks, Calif.Keywords: regulatory guidance on DMCs, drug safety -
What will it take for an injectable ARV to change the face of the HIV epidemic in high‐prevalence countries? Considerations regarding drug costs and operations
Free accessWiley | 2023|funders, such as PEPFAR and the Global Fund, and a fairly rapid scale‐up of the drug. Such a scale‐up would have to involve speedy regulatory ... -
What Drug Development Sponsors, Contract Research Organizations, and Investigators Can Do to Increase Diversity in Clinical Trials
Wiley | 2020|Keywords: regulatory/scientific affairs -
WGCNA and molecular docking reveal key hub genes and potential natural inhibitor in interstitial cystitis/bladder pain syndrome
Online Contents | 2022|of this study is to determine the key genes and specific regulatory pathways related to it and to find potential drug-active components ...Publisher: Springer International Publishing, Springer, London [u.a] -
Wearable sensors with possibilities for data exchange: Analyzing status and needs of different actors in mobile health monitoring systems
Elsevier | 2019|Access to data is often disabled due to missing verification of data prediction models or unsatisfactory regulatory requirements ...Keywords: Food and Drug Administration -
Voluntary licensing of long‐acting HIV prevention and treatment regimens: using a proven collaboration‐ and competition‐based mechanism to rapidly expand at‐scale, sustainable, quality‐assured and affordable supplies in LMICs
Free accessWiley | 2023|and regimens could be game‐changing for the HIV response, helping reach the ambitious goal of halting the epidemic by 2030. To attain this ... -
VigiBase, the WHO Global ICSR Database System: Basic Facts
Online Contents | 2008|Abstract The main aim of the WHO International Drug Monitoring Programme, started in 1968, is to identify the earliest possible ...Publisher: Springer International Publishing, Sage, Thousand Oaks, Calif. -
Validation of cell‐based fluorescence assays: Practice guidelines from the ICSH and ICCS – part IV – postanalytic considerations
Wiley | 2013|International Council for Standardization of Haematology (ICSH) and International Clinical Cytometry Society (ICCS). Accordingly, a group of over 40 ... -
Validation of cell‐based fluorescence assays: Practice guidelines from the ICSH and ICCS – part I – rationale and aims
Wiley | 2013|International Council for Standardization of Haematology (ICSH) and International Clinical Cytometry Society (ICCS). Accordingly, a group of over 40 ... -
Validation of cell‐based fluorescence assays: practice guidelines from the ICSH and ICCS – part II – preanalytical issues
Wiley | 2013|International Council for Standardization of Haematology (ICSH) and International Clinical Cytometry Society (ICCS). Accordingly, a group of over 40 ...Keywords: regulatory science -
Vaccine policy, regulations and safety in India
IOS Press | 2009nation completely dependent on imported vaccines to one not only self-sufficient in the production of vaccines conforming to international ... -
U.S. National Bureau of Standards/ atomic industrial forum radioactivity measurements assurance program
National licenceElsevier | 1983|, the companies have made it easier to comply with some of the regulatory requirements of the FDA and NRC when applying for new drug ... -
Using Meddra for Adverse Events in Cancer Trials: Experience, Caveats, and Advice
Online Contents | 2001|Abstract The Medical Dictionary for Regulatory Activities (MedDRA) will be the standard coding dictionary for adverse events in the future ...Publisher: Springer International Publishing, Sage, Thousand Oaks, Calif. -
Using Data Mining to Predict Safety Actions from FDA Adverse Event Reporting System Data
Online Contents | 2007|Abstract Purpose: To determine the value of data mining in early identification of drug safety signals from spontaneous reporting databases ...Publisher: Springer International Publishing, Sage, Thousand Oaks, Calif. -
Use of Robots in Critical Care: Systematic Review
Free accessDOAJ | 2022|reduced response time, earlier intervention, and lower mortality rates. Challenges of telepresence included regulatory and financial barriers. In ...Keywords: Public aspects of medicine -
Use and Abuse of Placebo in Clinical Trials
Online Contents | 1999|PCT and that such misuse is being driven by the requirements of the pharmaceutical industry and pharmaceutical regulatory authorities. In this ...Publisher: Springer International Publishing, Sage, Thousand Oaks, Calif.
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