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 Concerns at Various Phases of Drug Development
British Library Conference Proceedings | 1998| -
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 -
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 -
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 -
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 ... -
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 -
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 -
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 -
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 -
Study on the Effect of Three CYP2C9 Variants on Drug–Drug Interaction Related to Six Drugs In Vitro by LC–MS/MS Method
Springer Verlag | 2022|The influence of genetic polymorphism of metabolic enzymes on drug–drug interactions (DDI) should be
...Keywords: Drug–drug interaction -
Structural aspects of the interaction of anticancer drug Actinomycin-D to the GC rich region of hmgb1 gene
Online Contents | 2016|hmgb1 gene and selected a positive regulatory element of 25 base pair duplex (25RY) (-165 to -183) as a potential target for chemotherapeutic ... -
Structural aspects of the interaction of anticancer drug Actinomycin-D to the GC rich region of hmgb1 gene
Elsevier | 2016|regulatory element of 25 base pair duplex (25RY) (−165 to −183) as a potential target for chemotherapeutic intervention. The molecular interaction of ...Keywords: Drug–DNA interaction -
Perspective on Advancing FDA Regulatory Monitoring for Mycotoxins in Foods using Liquid Chromatography and Mass Spectrometry (Review)
Online Contents | 2016|The presence of mycotoxins (such as aflatoxins, deoxynivalenol, fumonisins, and patulin) is routinely monitored by the U.S. Food and Drug ... -
Relaxin as a Cardiovascular Drug: A Promise Kept
Bentham Science Publishers | 2011|remodelling. This mini-review was intended as an update of our previous article that appeared in this journal in 2009, as the last 2 years have been ...Keywords: Clinical Trials & Regulatory Affairs, Drug Design and Discovery -
Genome analysis of Chlamydia trachomatis for functional characterization of hypothetical proteins to discover novel drug targets
Elsevier | 2016|diseases. The D/UW-3/Cx strain of C. trachomatis contains 935 genes and three pseudogenes. Out of these genes, 887 genes code for ...Keywords: Drug discovery -
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
... -
HPTLC Analysis of Venlafaxine Hydrochloride in the Bulk Drug and Tablets
Springer Verlag | 2010|pharmaceutical regulatory standards. The selectivity, accuracy, precision, and speed of the method make it useful for routine analysis of the ...Publisher: Springer International Publishing, ChamKeywords: Pharmaceutical regulatory standards -
Starch chemical modifications applied to drug delivery systems: From fundamentals to FDA-approved raw materials
Elsevier | 2021|these materials. The fundamentals of drug delivery systems, regulatory aspects, and chemical modifications are also discussed, along with the ...Keywords: drug delivery systems, Drug delivery systems -
Casein Kinase II: An attractive target for anti-cancer drug design
Elsevier | 2010|relevance of CK2 biology to cellular transformation and carcinogenesis. Due to the critical regulatory role CK2 plays in cell fate determination in ...Keywords: inhibitor of kappa B -
Integrative identification of core genetic regulatory modules via a structural model-based clustering method
British Library Conference Proceedings | 2011| -
Globalisation of drug regulation and drug regulators in developing countries
Groping in the dark even when there is a light switch; an example from Sri LankaIOS Press | 1996Drug regulatory agencies in developing countries are often relatively small and poorly funded; they are therefore necessarily heavily
... -
HPTLC Analysis of Venlafaxine Hydrochloride in the Bulk Drug and Tablets
Online Contents | 2010|validation in accordance with the requirements of pharmaceutical regulatory standards. The selectivity, accuracy, precision, and speed of the method ...Publisher: Springer International Publishing, Akadémiai Kiadó, Budapest -
Inhibitors of CPH1-MAP Kinase Pathway: Ascertaining Potential Ligands as Multi-Target Drug Candidate in Candida albicans
Online Contents | 2018|albicans. These proteins are essential targets for their involvement in the successful establishment of the fungi within the host. In silico drug ... -
Detection of Two Genotoxic Impurities in Drug Substance and Preparation of Imatinib Mesylate by LC–MS/MS
Springer Verlag | 2020|> 0.998) was obtained at the concentration range of 0.02–35.27 and 0.02–28.86 ng mL−1, respectively. The LOD of IMA in drug substances ...Keywords: Drug substance -
Asymmetric-flow field-flow fractionation for measuring particle size, drug loading and (in)stability of nanopharmaceuticals. The joint view of European Union Nanomedicine Characterization Laboratory and National Cancer Institute - Nanotechnology Characterization Laboratory
Elsevier | 2020|Multi-detector AF4 for characterization of nanomedicines is reviewed ...Keywords: regulatory framework -
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 -
A Critical N-Nitrosamine Impurity of Anticoagulant Drug, Rivaroxaban: Synthesis, Characterization, Development of LC–MS/MS Method for Nanogram Level Quantification
Springer Verlag | 2022|levels of carcinogenic potential N-nitrosamine impurities has been a severe apprehension in recent years. The regulatory ... -
Homopurine/homopyrimidine sequences as potential regulatory elements in eukaryotic cells
National licenceElsevier | 1993|-specific drug delivery, and selective modulation of gene expression. ... -
Food and Drug Administration Pesticide Program Residue Monitoring 2003
NTIS | 2003This document is the seventeenth annual report summarizing the results of the Food and Drug Administrations (FDA) pesticide residue ...Publisher: Food and Drug Administration, Rockville, MD -
Regulatory effects of synthetic liver X receptor- and peroxisome-proliferator activated receptor agonists on sterol transport pathways in polarized cerebrovascular endothelial cells
Elsevier | 2006|cells apoA–I, ABCA1, and SR-BI represent drug targets for LXR and PPAR-agonists to interfere with cholesterol homeostasis at the periphery of ... -
A quantitative approach of using genetic algorithm in designing a probability scoring system of an adverse drug reaction assessment system
Elsevier | 2007|adverse drug reactions (ADRs) are well established. Hence, precise and accurate assessment of ADRs’ causality which can differentiate signal from ... -
Food and Drug Administration Pesticide Program Residue Monitoring, 2002
NTIS | 2002This document is the sixteenth annual report summarizing the results of the Food and Drug Administrations (FDA) pesticide residue ...Publisher: Food and Drug Administration, Washington, DC -
A review on the advances in the extraction methods and structure elucidation of Poria cocos polysaccharide and its pharmacological activities and drug carrier applications
Elsevier | 2022|, etc. There is the potential application of PCP as drug carriers. The review provides a comprehensive summary of the latest extraction and ...Keywords: Drug carrier application -
Food and Drug Administration Pesticide Program Residue Monitoring, 2001
NTIS | 2001This document is the fifteenth annual report summarizing the results of the Food and Drug Administrations (FDA) pesticide residue ...Publisher: Food and Drug Administration, Washington, DC -
Report on the tenth APCA government affairs seminar. Air quality: Status, management and direction
Tema Archive | 1982|. This meeting served as a forum for discussion of the issues of: the Clean Air Act amendments, regulatory reform, international perspectives on ... -
Food and Drug Administration Pesticide Program Residue Monitoring, 1999
NTIS | 1999This is the thirteenth annual report summarizing the results of the Food and Drug Administrations (FDA) pesticide residue monitoring ...Publisher: Food and Drug Administration, Washington, DC -
Food and Drug Administration Pesticide Program Residue Monitoring, 1998
NTIS | 1998This is the twelfth annual report summarizing the results of the Food and Drug Administrations (FDA) pesticide residue monitoring program ...Publisher: Food and Drug Administration, Washington, DC -
Food and Drug Administration Pesticide Program Residue Monitoring, 1995
NTIS | 1995. The 8 previous reports, which were published in the Journal of the Association of Official Analytical Chemists/Journal of AOAC International ...Publisher: Food and Drug Administration, Washington, DC -
Food and Drug Administration Pesticide Program Residue Monitoring, 1996
NTIS | 1996This is the tenth annual report summarizing the results of the Food and Drug Administrations (FDA) pesticide residue monitoring program ...Publisher: Food and Drug Administration, Washington, DC -
Food and Drug Administration Pesticide Program Residue Monitoring, 1997
NTIS | 1997This is the eleventh annual report summarizing the results of the Food and Drug Administrations (FDA) pesticide residue monitoring program ...Publisher: Food and Drug Administration, Washington, DC -
International harmonisation – the need for transparency
IOS Press | 1996International harmonisation of drug regulatory procedures could contribute both to efficiency and to drug safety. The International
...
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