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Japanese encephalitis vaccines first became available in the 1930s. [3] One of them was an inactivated mouse brain-derived vaccine (the Nakayama and/or Beijing-1 strain), made by BIKEN and marketed by Sanofi Pasteur as JE-VAX, until production ceased in 2005.
Monthly Prescribing Reference (MPR) is a widely recognized medical publication that provides comprehensive drug information and prescribing guidelines for healthcare professionals. It is designed to serve as a quick reference guide for physicians, pharmacists, nurse practitioners, and other medical professionals involved in prescribing medications.
The Prescribing Information follows one of two formats: "physician labeling rule" format or "old" (non-PLR) format. For "old" format labeling a "product title" may be listed first and may include the proprietary name (if any), the nonproprietary name, dosage form(s), and other information about the product. The other sections are as follows:
The approval of pexidartinib was based on the results of a multi-center international clinical trial of 120 subjects, 59 of whom received placebo. [2] The primary efficacy endpoint was the overall response rate (ORR) analyzed after 25 weeks of treatment. [2]
The DRKS is an open access, free of charge online register for clinical trials and is available both in English and German. DRKS is part of the WHO's ICTRP. The DRKS works with two partner registries in Germany, DeReG (German Registry for Somatic Gene-Transfer Trials) and Clinical Trial Registry of the University Medical Center Freiburg. [4]
In drug development and medical device development [1] the Investigator's Brochure (IB) is a comprehensive document summarizing the body of information about an investigational product ("IP" or "study drug") obtained during a drug trial. The IB is a document of critical importance throughout the drug development process and is updated with new ...
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