Search results
Results from the WOW.Com Content Network
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 ...
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.
The certificate of pharmaceutical product (abbreviated: CPP) is a certificate issued in the format recommended by the World Health Organization (WHO), which establishes the status of the pharmaceutical product and of the applicant for this certificate in the exporting country; [1] it is often mentioned in conjunction with the electronic Common Technical Document (eCTD).
-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.
Office Open XML (OOXML) format was introduced with Microsoft Office 2007 and became the default format of Microsoft Word ever since. Pertaining file extensions include:.docx – Word document.docm – Word macro-enabled document; same as docx, but may contain macros and scripts.dotx – Word template.dotm – Word macro-enabled template; same ...
Main page; Contents; Current events; Random article; About Wikipedia; Contact us; Pages for logged out editors learn more
Good documentation practice (recommended to abbreviate as GDocP to distinguish from "good distribution practice" also abbreviated GDP) is a term in the pharmaceutical and medical device industries to describe standards by which documents are created and maintained.
The FDA addresses the warning letter to the highest known official in the firm that owns the inspected facility, and sends a copy to the highest known official at the specific inspected facility. If the FDA expects a separate response from other officials, they may included their addressees.