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FDA hydrolysis is often used to measure activity in soil and compost samples; however, it may not give an accurate reading if microbes with lower activity phases, such as esterases, cleave the fluorescein first. It is also used in combination with propidium iodide (PI) to determine viability in eukaryotic cells. Living cells will actively ...
Structured Product Labeling (SPL) is a Health Level Seven International (HL7) standard which defines the content of human prescription drug labeling in an XML format. [1] The "drug labeling" includes all published material accompanying a drug, such as the Prescribing Information which contains a great deal of detailed information about the drug.
.xlsm – Excel macro-enabled workbook; same as xlsx but may contain macros and scripts.xltx – Excel template.xltm – Excel macro-enabled template; same as xltx but may contain macros and scripts; Other formats Microsoft Excel uses dedicated file formats that are not part of OOXML, and use the following extensions:.xlsb – Excel binary ...
-FDA agreed with many of these arguments and encouraged the sponsor to submit a response to the NA letter. However, we did ask that they try to apply a pproaches developed by Sheiner, et al, to try to better understand the dose response relationship from the available data. We also asked for additional safety information.
It was developed by the European Medicines Agency (EMA, Europe), the Food and Drug Administration (USA) and the Ministry of Health, Labour and Welfare (Japan) starting at World Health Organization International Conference of Drug Regulatory Authorities (ICDRA) at Paris in 1989.
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 ...
An Abbreviated New Drug Application (ANDA) is an application for a U.S. generic drug approval for an existing licensed medication or approved drug. The ANDA is submitted to FDA's Center for Drug Evaluation and Research, Office of Generic Drugs, which provides for the review and ultimate approval of a generic drug product. Once approved, an ...
A biologics license application (BLA) is defined by the U.S. Food and Drug Administration (FDA) as follows: The biologics license application is a request for permission to introduce, or deliver for introduction, a biologic product into interstate commerce (21 CFR 601.2). The BLA is regulated under 21 CFR 600 – 680.