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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.
However, work stalled on the project. An additional Draft Implementation Guide was released in February 2015 [5] The ICH and the FDA released draft specifications and guides in April 2016, and on May 13 there was an ICH "teleconference" to discuss the guidance and any queries or clarifications that might be necessary. [6]
The CTD is maintained by the International Council on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). [ 1 ] [ 2 ] After the United States, European Union and Japan, the CTD was adopted by several other countries including Canada [ 3 ] and Switzerland.
The ego (German: Ich), one of the psychic apparatus defined in Sigmund Freud's structural model of the psyche; Infectious canine hepatitis, an acute liver infection in dogs; Ichthyophthirius multifiliis, often shortened to ich, a disease of freshwater fish Cryptocaryon or marine ich, a similar disease of marine fish
The most common form in dogs is multicentric, involving the lymph nodes. [165] Fibrosarcoma is a malignant tumor that most commonly occurs in the mouth in dogs, and less commonly in the skin, subcutis, and bones. [6] Aggressive fibromatosis, also known as desmoid fibromatosis, a type of non-metastasizing soft-tissue sarcoma, may occur in dogs ...
Owing to the importance of the IB in maintaining the safety of human subjects in clinical trials, and as part of their guidance on good clinical practice (GCP), the U.S. Food and Drug Administration (FDA) has written regulatory codes and guidances for authoring the IB, and the International Conference on Harmonisation (ICH) has prepared a ...