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Voriconazole, sold under the brand name Vfend among others, is an antifungal medication used to treat a number of fungal infections. [5] This includes aspergillosis , candidiasis , coccidioidomycosis , histoplasmosis , penicilliosis , and infections by Scedosporium or Fusarium . [ 5 ]
Voriconazole is also being studied in salvage therapy for refractory cases. A case report indicated that voriconazole in combination with amphotericin B as salvage therapy for disseminated coccidioidomycosis was successful. Several case reports have studied caspofungin, with differing results. Caspofungin 50 mg/day following administration of ...
Annex I of the Directive incorporates OECD Revised Guides for Compliance Monitoring Procedures for GLP, along with OECD Guidance for the Conduct of Test Facility Inspections and Study Audits. It ensures compliance with these guidelines during laboratory inspections and study audits. This directive replaced Directive 88/320/EEC as of 11 March 2004.
An antifungal medication, also known as an antimycotic medication, is a pharmaceutical fungicide or fungistatic used to treat and prevent mycosis such as athlete's foot, ringworm, candidiasis (thrush), serious systemic infections such as cryptococcal meningitis, and others.
Good documentation practice (recommended to abbreviate as GDocP to distinguish from "good distribution practice" also abbreviated GDP) is a term in the pharmaceutical and medical device industries to describe standards by which documents are created and maintained.
Drugs which may be started with an initial loading dose include digoxin, teicoplanin, voriconazole, procainamide and fulvestrant. One or series of doses that may be given at the onset of therapy with the aim of achieving the target concentration rapidly.
Clinical monitoring is the oversight and administrative efforts that monitor a participant's health and efficacy of the treatment during a clinical trial.Both independent and government-run grant-funding agencies, such as the National Institutes of Health (NIH) [1] and the World Health Organization (WHO), [2] require data and safety monitoring protocols for Phase I and II clinical trials ...
Safety monitoring procedures; An IB contains a "Summary of Data and Guidance for the Investigator" section, of which the overall aim is to "provide the investigator with a clear understanding of the possible risks and adverse reactions, and of the specific tests, observations, and precautions that may be needed for a clinical trial.