MDI and DPI Drug Products
...establish a set of criteria to which a drug substance or drug product should conform using.....discuss significant departures from the approaches outlined in this guidance with the.....quantitative test with appropriate acceptance criteria should be established for the.. 474..
http://www.fda.gov/cder/guidance/2180dft.pdf (score=100)

Guidance for Industry
...product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of.....deviation is considered to have compromised the integrity of the sterility test, the test.....regardless of acceptance criteria, would be a signal of an adverse trend on the aseptic..
http://www.fda.gov/OHRMS/DOCKETS/98fr/1874dft.pdf (score=104)

Guidance for Industry: Manufacturing, Processing, or Holding Active...
...Once drug development reaches the stage where the API is produced for use in drug products.....Deviations from written specifications, standards,sampling plans, test procedures, or.....the batch selection criteria and analytical data that will be evaluated to determine..
http://www.fda.gov/cder/guidance/1289dft.pdf (score=100)

FR Doc 03-14140
...Evaluation of the Z values for the two 1-hour test days and the 24-hour test day showed that both products were.....The agency needs appropriate effectiveness data and an appropriate USP-NF monograph.....The OTC drug review was designed to implement both the misbranding and the new drug..
http://www.fda.gov/OHRMS/DOCKETS/98fr/03-14140.htm (score=98)

Document
...as safe and effective and not misbranded active ingredients in OTC drug products document.....definition test, there was at least a 20- the last antiperspirant application. controlled.....at 20 percent sweat reduction, met one of the extra effective criteria. active ingredient..
http://www.fda.gov/OHRMS/DOCKETS/98fr/03-14140.pdf (score=98)

March/April 1999 FDA Veterinarian Newsletter
...CVM's Office of New Animal Drug Evaluation acted on 6,513 submissions for new animal drug.....The test methods to determine the concentration of the active ingredient in Type A.....The evaluation criteria for Type C Medicated feed methods are the same whether the methods..
http://www.fda.gov/cvm/index/fdavet/1999/march.html (score=97)

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