2021-08-26 06:57 CMC stands for Chemistry, Manufacturing and Controls. The process in which drugs are evaluated with regard to their specific qualifications is called CMC documentation. It defines not only the manufacturing process itself but also the quality control ... дальше
2021-08-26 06:57 The SmPC is part of the broader Product Information (PI), which also includes the Package Leaflet (PL) and names the authorization holder, as well as the conditions of the authorization. Accurate translation of drug instruction texts, especially thos ... дальше
2021-08-26 06:56 United States Prescribing Information (USPI) sets out the agreed usage of the drug. It provides information on usage for healthcare professionals, also known as the drug product label, prescription drug labeling, product insert, package insert, profe ... дальше
2021-08-26 06:56 More clinical trials are conducted in multi-countries, such as Asia, Latin America, or Central and Eastern Europe. Even US-based studies recruit the majority of the subjects for clinical studies outside the US. Translation is required at many stages ... дальше
