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Fluorescein diacetate (FDA) hydrolysis assays can be used to measure the enzyme activity of microbes in a sample. A bright yellow-green glow is produced and is strongest when enzymatic activity is greatest. This can be quantified using a spectrofluorometer or a spectrophotometer.
The United States Food and Drug Administration's Investigational New Drug (IND) program is the means by which a pharmaceutical company obtains permission to start human clinical trials and to ship an experimental drug across state lines (usually to clinical investigators) before a marketing application for the drug has been approved.
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 ...
Quality by design (QbD) is a concept first outlined by quality expert Joseph M. Juran in publications, most notably Juran on Quality by Design. [1] Designing for quality and innovation is one of the three universal processes of the Juran Trilogy, in which Juran describes what is required to achieve breakthroughs in new products, services, and processes. [2]
This is the file index.xml in the submission sequence number folder. For example: ctd-123456/0000/index.xml The purpose of this file is twofold: Manage meta-data for the entire submission; Constitute a comprehensive table of contents and provide corresponding navigation aid.
Default PDF and file viewer for GNOME; replaces GPdf. Supports addition and removal (since v3.14), of basic text note annotations. CUPS: Apache License 2.0: No No No Yes Printing system can render any document to a PDF file, thus any Linux program with print capability can produce PDF files Pdftk: GPLv2: No Yes Yes
The FDA's proposed rule would require manufacturers test samples of talc-containing cosmetic products for asbestos with methods including polarized light and transmission electron microscopy ...
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 ...