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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 ]
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.
The WHO Model List of Essential Medicines for Children (aka Essential Medicines List for Children [1] or EMLc [1]), published by the World Health Organization (WHO), contains the medications considered to be most effective and safe in children up to twelve years of age to meet the most important needs in a health system.
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 ...
The WHO Model List of Essential Medicines (aka Essential Medicines List or EML [1]), published by the World Health Organization (WHO), contains the medications considered to be most effective and safe to meet the most important needs in a health system. [2]
will maintain guidance documents on the format and content of applications to assist applicants in their preparation. (a) Application form. The applicant shall submit a completed and signed application form that contains the following: (1) The name and address of the applicant; the date of the application;
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.
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.