MDI and DPI Drug Products
...establish a set of criteria to which a drug substance or drug product should conform using.....distribution, crystallinity, dose content uniformity, microbial content, and stability.....Appropriate acceptance criteria and tests should be instituted to control those drug.. 236..
http://www.fda.gov/cder/guidance/2180dft.pdf (score=100)

...60 1 The test we have for dose content 2 uniformity or delivered dose uniformity for 3.....3 There was acceptance by the committee for 4 cytochrome P4502B6, that we do have both in.....We use statistical 10 criteria in our library model developments, and we 11 can use bad..
http://www.fda.gov/ohrms/dockets/ac/04/transcripts/4034T1.DOC (score=36)

Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Drug Products...
...The recommendations for acceptance criteria and tests for emitted dose content uniformity from the mouthpiece of DPIs under defined.....This test involves determining the dose content uniformity at the beginning of unit life, at.....Appropriate acceptance criteria and tests should be instituted to control those drug substance..
http://www.fda.gov/CDER/GUIDANCE/2180dft.htm (score=21)

Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Drug Products...
...The recommendations for acceptance criteria and tests for emitted dose content uniformity from the mouthpiece of DPIs under defined.....This test involves determining the dose content uniformity at the beginning of unit life, at.....Appropriate acceptance criteria and tests should be instituted to control those drug substance..
http://www.fda.gov/cder/guidance/2180dft.htm (score=21)

FDA Concept Paper: Drug Products That Present Demonstrable Difficulties for...
...The acceptance criteria should at a minimum meet the criteria proposed in The Pharmacopeial Forum.63.....This interaction can contribute to inconsistent dose delivery and particle size.....Generally, adequate tests measurecontent, content uniformity of the active ingredient..
http://www.fda.gov/cder/fdama/difconc.htm (score=21)

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 regulatory acceptance of modern in-line controls. 13 That was the thought process..
http://www.fda.gov/ohrms/dockets/ac/04/transcripts/4034T1.pdf (score=20)

stability guidance -draft
...when significant change in aerodynamic particle size distribution or in dose content uniformity.....such cases, alternate approaches, such as qualifying higher acceptance criteria for a.....container meeting dose content uniformity, aerodynamic particle size distribution..
http://www.fda.gov/cder/guidance/1707dft.pdf (score=12)

...For example, a CMC test such as dose content uniformity has acceptance criteria based on repeated manufacturing of.....Dose content uniformity or spray content uniformity release tests alone usually require 30.....When in vitro data fail to meet acceptance criteria, the applicant is encouraged to modify the test..
http://www.fda.gov/cder/guidance/5383DFT.doc (score=11)

BA/BE studies for Nasal Aerosols and Nasal Sprays for Local Ac
...test such as dose content uniformity has acceptance criteria based on repeated manufacturing of.....When in vitro data fail to meet acceptance criteria,the applicant is encouraged to modify the test.....single-dose or multiple-dose study exceed the single or total daily dose specified in the..
http://www.fda.gov/cder/guidance/2070dft.pdf (score=11)

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...Estimating the Safe Starting Dose in Clinical Trials for Therapeutics in Adult Healthy.....Format and Content of the Human Pharmacokinetics and Bioavailability Section of an.....Nuclear Pharmacy Guideline Criteria for Determining When to Register as a Drug..
http://www.fda.gov/cder/guidance/guidlist.pdf (score=4)

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