MDI and DPI Drug Products
...distribution, crystallinity, dose content uniformity, microbial content, and stability.....emitted dose content uniformity, particle size distribution, microscopic evaluation, 1619.....also known as oral and nasal metered dose inhalers respectively or MDIs) and inhalation..
http://www.fda.gov/cder/guidance/2180dft.pdf (score=100)

...Parametric Tolerance Interval Test (PTIT) for Dose Content Uniformity of Aerosol Products.....for Dose Content Uniformity Deputy Director, OPS, CDER, FDA Moving Forward -- An Approach for.....Dose Content Uniformity, and discussed the following: Process Analytical Technology (PAT..
http://www.fda.gov/ohrms/dockets/ac/04/minutes/4034M1.DOC (score=51)

...60 1 The test we have for dose content 2 uniformity or delivered dose uniformity for 3.....It is essentially a measurement of, it's 16 content uniformity, how much of the dose is 17 delivered in, let's say, a spray or.....2 That is the whole concept behind the 3 delivered dose uniformity, that the product has..
http://www.fda.gov/ohrms/dockets/ac/04/transcripts/4034T1.DOC (score=42)

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...He noted that there is need for a study design that has sensitivity to dose-response, thus.....Should there be a single content uniformity standard for all orally inhaled and nasal drug.....presented the FDA's current requirements for dose content uniformity(DCU) testing and..
http://www.fda.gov/ohrms/dockets/ac/00/minutes/3609m1.pdf (score=32)

ADVISORY COMMITTEE FOR PHARMACEUTICAL SCIENCE
...Presentation on the Work of the Specifications Team (Dose Content Uniformity/ Particle Size.....Dose Content uniformity: Current Practices for NDAs, Gurag Poochikian PhD .pdf.. Clinical.....Content Uniformity.. Alternative Statistical Approaches, Walter W. Hauck, Ph.D., Thomas..
http://www.fda.gov/ohrms/dockets/ac/00/slides/3609s1.htm (score=32)

FDA Concept Paper: Drug Products That Present Demonstrable Difficulties for...
...This interaction can contribute to inconsistent dose delivery and particle size.....Generally, adequate tests measurecontent, content uniformity of the active ingredient.....Minor changes in the concentration or dose of an excipient can result in markedly..
http://www.fda.gov/cder/fdama/difconc.htm (score=23)

Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Drug Products...
...This test involves determining the dose content uniformity at the beginning of unit life, at.....The recommendations for acceptance criteria and tests for emitted dose content uniformity from.....In the case of device-metered DPIs, the dose content uniformity should be established and..
http://www.fda.gov/CDER/GUIDANCE/2180dft.htm (score=23)

Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Drug Products...
...This test involves determining the dose content uniformity at the beginning of unit life, at.....The recommendations for acceptance criteria and tests for emitted dose content uniformity from.....In the case of device-metered DPIs, the dose content uniformity should be established and..
http://www.fda.gov/cder/guidance/2180dft.htm (score=23)

...He noted that there is need for a study design that has sensitivity to dose-response, thus.....Address and discuss questions related to the content uniformity of orally inhaled and.....If a clinical study is nondiscriminating to dose, rather than relying only on in vitro..
http://www.fda.gov/ohrms/dockets/ac/00/minutes/3609m1.doc (score=22)

file://///Tiffanie/C/storage/0413PHAR.TXT
...19 gone through, that you have real-time monitoring, 20 and not just of a unit dose sample.....6 to I think the content uniformity issue, and, 7 third, I guess in general, other.....12 USP test that is used for all content uniformity, 13 it is a variation on that. 14 Take..
http://www.fda.gov/ohrms/dockets/ac/04/transcripts/4034T1.pdf (score=22)

3609b1
...Initial Assessment of the ITFG/IPAC Dose Content Uniformity Database by the CMC Specifications..
http://www.fda.gov/ohrms/dockets/ac/00/techrepro/3609_reports.htm (score=22)

...for Dose Content Uniformity FDA Perspective IPAC-RS Perspective Committee Discussions and..
http://www.fda.gov/ohrms/dockets/ac/04/agenda/4034A1_Draft.doc (score=22)

ADVISORY COMMITTEE FOR PHARMACEUTICAL SCIENCE
...Dose Content Uniformity Issues, Guirag Poochikian, PhD  ppt   html.. Nonclinical Studies..
http://www.fda.gov/ohrms/dockets/ac/00/slides/3657s1.htm (score=22)

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...for Dose Content Uniformity .. FDA Perspective .. IPAC-RS Perspective .. Committee Discussions..
http://www.fda.gov/ohrms/dockets/ac/04/agenda/4034A1_Draft.pdf (score=22)

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...Parametric Tolerance Interval Test for Dose Content Uniformity, and discussed the.....Parametric Tolerance Interval Test (PTIT) for Dose Content Uniformity of Aerosol Products.....for Dose Content Uniformity .. Deputy Director, OPS, CDER, FDA .. Moving Forward -- An Approach..
http://www.fda.gov/ohrms/dockets/ac/04/minutes/4034M1.pdf (score=22)

...The first, dose content uniformity through container life, our working group has recommended.....One of the limitations of what we define as the lowest effective dose is a dose which separates.....content, that test and reference products are delivering the same amount of active drug..
http://www.fda.gov/ohrms/dockets/ac/01/transcripts/3764t1.txt (score=13)

...The first, dose content uniformity through container life, our working group has recommended.....One of the limitations of what we define as the lowest effective dose is a dose which separates.....content, that test and reference products are delivering the same amount of active drug..
http://www.fda.gov/ohrms/dockets/ac/01/transcripts/3764t1.htm (score=13)

FDA Updates--July-August 2004 FDA Consumer
...Veterinarians will determine the initial treatment dose based on the dog's weight and then.....In addition, the agency is proposing to extend sodium content labeling requirements to OTC.....For specific dose restrictions, see www.fda.gov/bbs/topics/news/2004/NEW01041.html. Drug..
http://www.fda.gov/fdac/departs/2004/404_upd.html (score=13)

stability guidance -draft
...when significant change in aerodynamic particle size distribution or in dose content uniformity.....container meeting dose content uniformity, aerodynamic particle size distribution.....microbial limit, moisture content, foreign particulates, content uniformity of the emitted..
http://www.fda.gov/cder/guidance/1707dft.pdf (score=13)

Food and Drug Administration
...s presentation of Difficulties in Showing a Dose-Response with Locally-Acting Nasal Sprays.....Aventis Pharma, presented an Update of ITFG/IPAC-RS Dose Content Uniformity (DCU) Working Group.....Dose Response. The meeting adjourned on July 19, 2001 at 5:02 p.m. For more detailed..
http://www.fda.gov/ohrms/dockets/ac/01/minutes/3763m1.htm (score=13)

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