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Infectious canine hepatitis (ICH) is an acute liver infection in dogs caused by Canine mastadenovirus A, formerly called Canine adenovirus 1 (CAV-1). Canine mastadenovirus A also causes disease in wolves, coyotes, and bears, and encephalitis in foxes. [1] The virus is spread
In the pharmaceutical industry, drug dissolution testing is routinely used to provide critical in vitro drug release information for both quality control purposes, i.e., to assess batch-to-batch consistency of solid oral dosage forms such as tablets, and drug development, i.e., to predict in vivo drug release profiles. [1]
In the 1980s, the European Union began harmonising regulatory requirements. In 1989, Europe, Japan, and the United States began creating plans for harmonisation. The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) was created in April 1990 at a meeting in Brussels.
Typically, the parameter derived from the biological property is AUC or Cmax, while the physicochemical property is the in vitro dissolution profile. The main roles of IVIVC are: To use dissolution test as a surrogate for human studies. To supports and/or validate the use of dissolution methods and specifications.
While many dog owners know that giving Fido chocolate can causing poisoning, there other lesser known foods that need to be kept away from your dog. 9 types of food you should never feed your dog ...
United States: Although ICH GCP guidelines are recommended by the Food and Drug Administration (FDA), [4] they are not statutory in the United States. The National Institutes of Health requires NIH-funded clinical investigators and clinical trial staff who are involved in the design, conduct, oversight, or management of clinical trials to be ...
ICH E6 includes details of only a minimum list of contents and no other regulation or guideline provides a comprehensive list of TMF content. As a result of the inconsistencies that were developing across the sector, an industry group comprising 7 members from the GCP-RMA (Good Clinical Practice Records Managers Association) decided to develop ...
All dogs coming into the U.S. from other countries must be at least 6 months old and microchipped to help prevent the spread of rabies, according to new government rules published Wednesday. The ...