Search results
Results from the WOW.Com Content Network
In the United States, the Food and Drug Administration (FDA) layers additional specifications onto its requirements for eCTD submissions, including PDF, transmission, file format, and supportive file specifications. [16] [17] In the European Union, the European Medicines Agency's EU Module 1 specification as well as other QA documents lay out ...
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]
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
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. [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.
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 ...
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
Section 5: Other Test Guidelines; Guidelines are numbered with three digit numbers, the section number being the first number. Sometimes guidelines are suffixed with a letter. Guidelines are under constant review, with guidelines being periodically updated, new guidelines being adopted, and guidelines being withdrawn.