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  2. Fluorescein diacetate hydrolysis - Wikipedia

    en.wikipedia.org/wiki/Fluorescein_diacetate...

    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 ...

  3. Allergen of the Year - Wikipedia

    en.wikipedia.org/wiki/Allergen_of_the_Year

    Allergen of the Year is an annual "award" voted upon by the American Contact Dermatitis Society, aiming to raise awareness about common allergens. The purpose of the award is "to draw attention to the agents causing the most significant clinical effects, those that are underrecognized and those that have become obsolete or for which exposure patterns have changed".

  4. APPLICATION NUMBER: NDA 20-272/S-036/041 NDA 20-588/S-024/028 ...

    highline.huffingtonpost.com/miracleindustry/...

    M E M O R A N D U M DEPARTMENT OF HEALTH AND HUMAN SERVICES PUBLIC HEALTH SERVICE FOOD AND DRUG ADMINISTRATION CENTER FOR DRUG EVALUATION AND RESEARCH DATE: July 14, 2006 FROM: Thomas P. Laughren, M.D. Director, Division of Psychiatry Products HFD-130 SUBJECT: Recommendation for approvable action for Risperdal (risperidone) for the

  5. Common Technical Document - Wikipedia

    en.wikipedia.org/wiki/Common_Technical_Document

    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.

  6. Patient Safety and Quality Improvement Act - Wikipedia

    en.wikipedia.org/wiki/Patient_Safety_and_Quality...

    Food and Drug Administration (FDA) — PSWP may be disclosed to the FDA By a provider concerning an FDA-regulated product or activity, By an entity required to report to the FDA about the quality, safety, or effectiveness of an FDA-regulated product or activity, or; By a contractor acting on behalf of the FDA or entity for these purposes

  7. Investigator's brochure - Wikipedia

    en.wikipedia.org/wiki/Investigator's_brochure

    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 ...

  8. Category:Drug templates by ATC - Wikipedia

    en.wikipedia.org/wiki/Category:Drug_templates_by_ATC

    [[Category:Drug templates by ATC]] to the <includeonly> section at the bottom of that page. Otherwise, add <noinclude>[[Category:Drug templates by ATC]]</noinclude> to the end of the template code, making sure it starts on the same line as the code's last character.

  9. Process performance qualification protocol - Wikipedia

    en.wikipedia.org/wiki/Process_Performance...

    Process performance qualification protocol is a component of process validation: process qualification.This step is vital in maintaining ongoing production quality by recording and having available for review essential conditions, controls, testing, and expected manufacturing outcome of a production process.