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The Development of a Regulatory Affairs and Quality Assurance Policy for a Hospital Supply Company
Emerald Group Publishing | 1987|relevant regulatory standards. This article describes a regulatory affairs and quality assurance programme instituted and operated by a major ...Keywords: Drug Industry -
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 -
Drug Withdrawal Due to Safety: A Review of the Data Supporting Withdrawal Decision
Free accessBentham Science Publishers | 2020|analyzed drugs withdrawn from the market between 1990 and 2010. All medicine agencies of the countries belonging to the Program for International ...Keywords: program for international drug monitoring, Clinical Trials & Regulatory Affairs, Drug Design and Discovery -
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 ... -
Exploiting Patent Regulatory “Flexibilities” to Promote Access to Antiretroviral Medicines in Sub‐Saharan Africa
Wiley | 2011|prevailing international patent regime. And, attempts to promote the manufacture and import of generic versions of antiretroviral drugs are sometimes ... -
The Reformulation Regime in Drug Discovery: Revisiting Polyherbals and Property Rights in the Ayurvedic Industry
Taylor & Francis Verlag | 2014|systems of appropriation and protection, which have not only gained central stage in the country but also influenced international regulatory ... -
The Politics of Local Biology in Transnational Drug Testing: Creating (Bio)Identities and Reproducing (Bio)Nationalism Through Japanese “Ethnobridging” Studies
Taylor & Francis Verlag | 2012|Union, and Japan cleared the way for the use of data generated in one member region to be used in another for drug regulatory approval purposes ... -
Food and Drug Administration FDA, USA. Struktur, Zulassungsverfahren und Inspektionsprocedere
Tema Archive | 1996|Office of Regulatory Affairs. Die FDA leitet ihre Existenz und Handlungen vom 'Federal Drug and Cosmetic Act' aus dem Jahre 1938 ab; ihre ...Keywords: USA (United States of America), Food and Drug Administration -
Planning operations before market launch for balancing time-to-market and risks in pharmaceutical supply chains
Elsevier | 2014|quantitative methodology can provide valuable decision support for product launch operations, even when complex regulatory affairs need to be ...Keywords: Regulatory affairs -
A Design Thinking Approach to Effective Vaccine Safety Communication
Bentham Science Publishers | 2015|The highly complex and controversial topic of vaccine safety communication warrants innovative, user-centered solutions that would start ...Keywords: Clinical Trials & Regulatory Affairs, Drug Design and Discovery -
Materiovigilance: Current status in India analogous to its global status
Free accessBASE | 2020|types of the medical devices are available in the international market. Thus, from the patient safety view point, assessment of the quality and ...Keywords: Materiovigilance Programme of India, Global Harmonization of Task Force -
Materiovigilance: Current status in India analogous to its global status
Free accessBASE | 2020|types of the medical devices are available in the international market. Thus, from the patient safety view point, assessment of the quality and ...Keywords: Materiovigilance Programme of India, Global Harmonization of Task Force -
AN INVESTIGATION INTO THE VALUE OF A STANDARDISED GLOBAL PHARMACOVIGILANCE REPORTING SYSTEM
Free accessDOAJ | 2017|Pharmacovigilance (PV) is based on the medical assessment of adverse medical events or drug-related problems, collected within organised ...Keywords: drug-related problems -
Quantitative measurement of amoxicillin in Ibuprofen tablets using UPLC
Elsevier | 2016|Method for the quantitative measurement of Amoxicillin in drug products was developed ...Keywords: international conference of harmonization, food and drug administration, design of experiment, limit of quantitation, limit of detection -
Planning operations before market launch for balancing time-to-market and risks in pharmaceutical supply chains
Online Contents | 2015|launch operations, even when complex regulatory affairs need to be considered. ... -
Planning operations before market launch for balancing time-to-market and risks in pharmaceutical supply chains
Tema Archive | 2015|launch operations, even when complex regulatory affairs need to be considered. ... -
Extraction of Oleic Acid from Animals Oil and Its Anti-inflammatory Effect on Network Pharmacology
Free accessSpringer Verlag | 2021|SuperPred server to find targets of compounds. Anti-inflammatory drug targets were collected through the CTD database. Go annotation of targets and ...Publisher: Springer International Publishing, Cham -
Planning pharmaceutical manufacturing networks in the light of uncertain production approval times
Elsevier | 2021|requires a production approval from regulatory authorities. The duration of the approval process is highly uncertain and can delay the completion ... -
Antidepressant-induced suicide, violence and mania: Risks for military personnel
IOS Press | 2010at military conferences on combat stress [8, 10] and in testimony before the U.S. House of Representatives Veterans Affairs Committee [9], I ...Keywords: antidepressant adverse drug reactions -
ZFAT and smart sensor promotes the progression of cervical cancer through mitotic pathway
Elsevier | 2020|ZFAT in the regulation of cervical cancer disease based on smart sensor ...