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Bringing Information on Evolving FDA Standards to Bear on Ongoing Drug Development Programs
Online Contents | 1999|Abstract The process of drug development and the introduction of a new product to the marketplace can be viewed as a regulatory exercise ...Publisher: Springer International Publishing, Sage, Thousand Oaks, Calif. -
Building Value Through Biomarkers: The “Smarter Development” Imperative
Online Contents | 2012|biopharmaceutical trends from the Tufts Center for the Study of Drug Development, it still takes, on average, 8 years to bring a new drug to market. The ...Publisher: Springer International Publishing, Sage, Thousand Oaks, Calif. -
Call to action: Harmonization of pharmacovigilance regulations for post‐marketing pregnancy and breastfeeding safety studies
Wiley | 2024|limited information on their safe use during pregnancy. The paucity of drug safety data on pregnant and breastfeeding women stems from the routine ...Keywords: drug safety -
Can I trust my fake data – A comprehensive quality assessment framework for synthetic tabular data in healthcare
Elsevier | 2024|Keywords: Analysis of variance F-test, Cancer Registry of Norway, the U.S. Food and Drug Administration, The International Medical Device Regulators Forum, Mean absolute error for means and standard deviations of columns, Precision in Estimation of Heterogeneous Effect (PEHE)), Predicted residual sum of squares -
Can Medicare Draw Lessons from Dutch Experience with a National Formulary?
Online Contents | 2007|from the US and Dutch drug regulatory agencies, three leading US managed care plans participating in the Medicare Advantage program, Michigan’s ...Publisher: Springer International Publishing, Sage, Thousand Oaks, Calif. -
Care Coordination Strategies and Barriers during Medication Safety Incidents: a Qualitative, Cognitive Task Analysis
Online Contents | 2021|barriers encountered, when they coordinate care during a medication safety incident involving an adverse drug reaction, drug-drug interaction, or ...Publisher: Springer International Publishing, Springer, New York, NY -
CBER’s New Managed Review Process: A Managed and Integrated Regulatory Process which is Continuous from Discovery to Post Marketing
Online Contents | 1998|principles of managed review to the entire regulatory process. Managed review principles include the design of a review process which is streamlined ...Publisher: Springer International Publishing, Sage, Thousand Oaks, Calif. -
CD25: A potential tumor therapeutic target
Wiley | 2023|CD25 is the alpha‐chain of the heterotrimer IL‐2 receptor. CD25 is expressed on the surface of both immune and
...Keywords: regulatory T cells -
Cell crowding induces interferon regulatory factor 9, which confers resistance to chemotherapeutic drugs
Wiley | 2015|The mechanism of multicellular drug resistance, defined as the reduced efficacy of chemotherapeutic drugs in solid tumors is
... -
Cell cycle‐dependent cytotoxicity and mitotic spindle checkpoint dependency of investigational and approved antimitotic agents
Wiley | 2012|distribution of the duplicated genome between daughter cells. Malfunction of the SPC or deregulated expression of SPC regulatory proteins is frequently ... -
Central nervous system-active drug abused and overdose in children: a worldwide exploratory study using the WHO pharmacovigilance database
Online Contents | 2018|the Standardised Medical Dictionary for Drug Regulatory Affairs Queries for Drug abuse. 8.682 reports matched our criteria. An increase in ...Keywords: Drug abuse, Drug safety -
Certification for the Medical Science Liaison: An Idea Whose Time Has Come—or Not
Online Contents | 2011|pharmaceutical companies in the United States. The shift in regulatory complexity, coupled with a waning acceptance and impact of the traditional “reach ...Publisher: Springer International Publishing, Sage, Thousand Oaks, Calif. -
Challenges of developing and conducting clinical trials in rare disorders
Wiley | 2018|development have been overcome through the focused efforts of patients/families, non‐profit patient advocacy groups, drug developers, and regulatory ...Keywords: Food and Drug Administration (FDA) -
Changes in the defined daily dose; CYP2D6/CYP3A metabolism as an indicator for dose-setting problems
Online Contents | 2005|Objective Interindividual variability is common at all stages of drug absorption, distribution, pharmacodynamics, metabolism and ...Keywords: Regulatory affairs -
Changes of immunological parameters with administration of Japanese Kampo medicine (Juzen-Taihoto/TJ-48) in patients with advanced pancreatic cancer
Online Contents | 2013|tumor cells was recently A focus. We reported that the population of $ Foxp3^{+} $$ CD25^{+} $$ CD4^{+} $ regulatory T cells ($ Foxp3^{+} $Treg ...Keywords: Regulatory T cell -
Changes to the European Regulatory Guidelines for the Approval of Antiretroviral Agents
Online Contents | 1999|guidelines, which are similar to those of the United States Food and Drug Administration, permit the use of short-term plasma HIV-1 RNA data for ...Publisher: Springer International Publishing, Sage, Thousand Oaks, Calif. -
Changing the Review Process: The View of the Japanese Ministry of Health and Welfare
Online Contents | 1998|Abstract On the basis of the discussion at the Committee for Drug Safety Ensuring Measures, the Japanese Ministry of Health and Welfare ...Publisher: Springer International Publishing, Sage, Thousand Oaks, Calif. -
Characterization of the breast cancer resistance protein (BCRP/ABCG2) in clear cell renal cell carcinoma
Wiley | 2018|relevance and regulatory mechanisms of BCRP/ABCG2 in clear cell renal cell carcinoma (ccRCC) and disease progression. Two independent ccRCC ... -
Childhood cancer drugs in China: An overview and comparison of regulatory approvals in China and the United States
Wiley | 2022|and Drug Administration approval. A harmonised, evidence‐based regulatory framework is needed to ensure approvals of needed, safe and ...Keywords: international comparison -
Clarifying the Discussion Points in New Drug Application Reviews for Approval in Japan by a Government Advisory Council
Online Contents | 2017|Background In Japan, the Pharmaceutical Affairs and Food Sanitation Council (PAFSC) of the Ministry of Health, Labour and Welfare conducts ...Publisher: Springer International Publishing, Springer Nature, [New York]Keywords: regulatory science, new drug applications
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