Year of publication
Type of media
Subject
Type of material
Licence
Language
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International course: Clinical drug development—Scientific and regulatory strategies
National licenceLeiden, January 21–22, 1982Elsevier | 1981 -
Chitosan-based microneedles as a potential platform for drug delivery through the skin: Trends and regulatory aspects
Elsevier | 2021|significant interest due to its ability of film-forming, biodegradability, and biocompatibility, making it suitable for topical and transdermal drug ...Keywords: Regulatory aspects -
Medical Affairs
Wiley | 2010|Keywords: Medical Affairs, Consolidated Standards of Reporting Trials (CONSORT), New Drug Application (NDA), International Committee of Medical Journal Editors (ICMJE) -
Regulatory and Quality Aspects of Herbal Drugs
Bentham Science Publishers | 2017|interaction, side effects, toxicity and adverse effects. The International Drug Monitoring Program of World Health Organization (WHO) has made certain ...Keywords: regulatory authority, drug interactions., Clinical Trials&Regulatory Affairs -
Regulatory Concerns at Various Phases of Drug Development
British Library Conference Proceedings | 1998| -
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 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 -
Aspect of adhesives in transdermal drug delivery systems
Tema Archive | 2014|effective amount of drug across the skin. The quality attribute of the adhesives in TDDS is indispensible for fabrication design and important to ... -
Information on adverse drug reactions—Proof of principle for a structured database that allows customization of drug information
Elsevier | 2019|. Allocation of most characteristics is standardizable, automatable, and scalable ...Keywords: Adverse drug reaction, United States Food and Drug Administration, Medical Dictionary for Regulatory Activities, Proof-of-principle, Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events, Summary of Product Characteristics, Zulassungsnummer (drug approval number), Adverse drug reactions, Summary of product characteristics, Structured drug information -
Regulatory Requirements for Collection, Administration and Transfusion of Blood and Blood Products
Bentham Science Publishers | 2017|Blood is considered as a life saving tissue. World Health Organization (WHO) has considered “Blood” under the definition of “Drug,” in Drug ...Keywords: blood regulatory network, regulatory guidelines of blood products, Clinical Trials&Regulatory Affairs -
Xyloglucan: A functional biomacromolecule for drug delivery applications
Elsevier | 2017|obtained from Tamarind seeds or kernel.The important properties of xyloglucan include ...Keywords: Drug delivery -
Predicting drug‐induced arrhythmias by multiscale modeling
Wiley | 2018|associated electrocardiogram. We demonstrate the potential of our model for a low‐risk drug, ranolazine, and a high‐risk drug, quinidine: For ... -
Chitosan as a suitable nanocarrier material for anti-Alzheimer drug delivery
Online Contents | 2015|Chitosan, a biocompatible natural polysaccharide is frequently reported carrier material in targeted drug delivery to treat ...Keywords: Blood-Brain Barrier - drug effects, Drug Carriers - chemistry, Alzheimer Disease - drug therapy, Drug Carriers - therapeutic use -
Chitosan as a suitable nanocarrier material for anti-Alzheimer drug delivery
Elsevier | 2014|reported carrier material in targeted drug delivery to treat neurodegenerative disorders. Chitosan and its biodegradable products exert its ... -
Therapeutic targeting of TANK-binding kinase signaling towards anticancer drug development: Challenges and opportunities
Elsevier | 2022|pathways. Post-translational modifications (PTM) of TBK1 control its action and subsequent cellular signaling. The dysregulation of the TBK1 ...Keywords: Stimulator of interferon genes, Interferon regulatory factor 3 -
Detecting adverse drug reactions in discharge summaries of electronic medical records using Readpeer
Elsevier | 2019|REAP achieves over 90% precision & recall for drug & AE name recognition on EHRs ...Keywords: Adverse drug reaction -
Development of Statistical Computational Tools Through Pharmaceutical Drug Development and Manufacturing Life Cycle
Springer Verlag | 2019|Regulatory Affairs (Reg CMC) have developed many statistical R-based computational tools to enable high efficiency, consistency, and fast turnaround ...Publisher: Springer International Publishing, ChamKeywords: Design of experiment -
Plant-derived exosomes: a green approach for cancer drug delivery
Royal Society of Chemistry | 2024|limitations of traditional drug delivery tools. Extraction of PDEs from plant sources employ diverse methodologies, encompassing ultracentrifugation ...Publisher: The Royal Society of Chemistry -
Missed Paracetamol (Acetaminophen) Overdose Due to Confusion Regarding Drug Names
Bentham Science Publishers | 2013|harmonisation of international drug names to improve patient safety. ...Keywords: drug name, drug nomenclature, drug safety, generic drug, proprietary drug., Clinical Trials & Regulatory Affairs, Drug Design and Discovery
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