Year of publication
Type of material
Licence
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An ISDB survey to assess the degree of transparency of drug regulatory agencies
IOS Press | 1996Members and correspondents of the International Society of Drug Bulletins (ISDB) from 23 countries responded to a questionnaire
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Potential Use of DNA Barcodes in Regulatory Science: Identification of U.S. Food and Drug Administration's "Dirty 22," Contributors to the Spread of Foodborne Pathogens
Online Contents | 2013|Publisher: International Association for Food Protection, Des Moines, Iowa -
A Review on Resealed Erythrocyte as a Newer Drug Carrier System
Free accessBASE | 2019|have been shown to have greater potential in the delivery of drugs here are currently 30 major products on the market to deliver drug. Carrier ...Keywords: drug targeting -
Regulatory Status of Excipients in Japan
Online Contents | 1999|testing of the preparations. Thus, the evaluation of excipients requires an understanding of the preparation as a whole in addition to the ...Publisher: Springer International Publishing, Sage, Thousand Oaks, Calif. -
Pharmacogenetics of Drug-Resistant Epilepsy (Review of Literature)
Free accessDOAJ | 2021|drug resistance, different response to the drug, the possibility of using reliable methods to assess the control of seizures and side effects ...Keywords: drug-resistant epilepsy -
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 -
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 and Informed Consent
Online Contents | 2008|Abstract The protection of the rights and welfare of study subjects is a hallmark of clinical research practice in most countries. However ...Publisher: Springer International Publishing, Sage, Thousand Oaks, Calif. -
An Appraisal of Good Regulatory Review Practices in the Gulf Cooperation Council States
Online Contents | 2012|Abstract The aim of this study was to evaluate how each Gulf Cooperation Council (GCC) regulatory authority is building quality into the ...Publisher: Springer International Publishing, Sage, Thousand Oaks, Calif.Keywords: regulatory review -
Risk undermined in the bilateral pharmaceutical regulatory system in Taiwan
Free accessDOAJ | 2018|The concept of Pharmacovigilance Planning and Risk Minimization Planning (PVP/RMP), initiated by the International Conference on ... -
Editorial of Special Issue “Regulatory Roles of Inflammasomes in Human Diseases”
Free accessDOAJ | 2021|step) and triggering (activation step). The key feature of the triggering step is the activation of inflammasomes that are intracellular ... -
Development of a Highly Sensitive Method for Quantitative Estimation of Dimethyl Sulfate Impurity in Neostigmine Methylsulfate Drug substances by Using GC-MS
Free accessBASE | 2019|Sulfate (DMS) impurity in Neostigmine Methylsulfate drug substance. The method was validated as per International Council for Harmonisation (ICH ... -
Aspect of adhesives in transdermal drug delivery systems
Elsevier | 2013|“patches,” are the dosage forms designed to deliver a therapeutically effective amount of drug across the skin. The quality attribute of the ... -
Environmental Assessment of Pharmaceuticals in Canada: A Regulatory Perspective
Online Contents | 2007|Abstract The development of environmental assessment regulations for pharmaceuticals and personal care products is currently under way in ...Publisher: Springer International Publishing, Sage, Thousand Oaks, Calif. -
Transvaginal mesh: a historical review and update of the current state of affairs in the United States
Online Contents | 2016|Introduction Transvaginal mesh usage has been at the forefront of popular media and academic debate for the past 10 years. Several US Food ... -
Unveiling the Features of a Regulatory System: The Institutional Grammar of Tobacco Legislation in Mexico
Taylor & Francis Verlag | 2015|The United Nations will host a drug policy summit in 2016. This will be a good forum to evaluate the effectiveness of existing legal
...Keywords: drug policy -
Positive and Negative Effects of Antipsychotic Medication: An International Online Survey of 832 Recipients
Bentham Science Publishers | 2019|experience of recipients.Objective: To ascertain the experiences and opinions of an international sample of users of antipsychotic drugs
...Keywords: Clinical Trials & Regulatory Affairs, Drug Design, Discovery & Therapy -
General Interest - Role of the U.S. Food and Drug Administration in the Regulatory Management of Human Listeriosis in the United States
Online Contents | 2008|Publisher: International Association for Food Protection, Des Moines, Iowa -
Analytical Quality by Design: A Tool for Regulatory Flexibility and Robust Analytics
Free accessDOAJ | 2015|Very recently, Food and Drug Administration (FDA) has approved a few new drug applications (NDA) with regulatory flexibility for quality by ...
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