MDI and DPI Drug Products
...manufacturing, processing, packaging, controls, stability testing, or labeling operations.....distribution, crystallinity, dose content uniformity, microbial content, and stability.....emitted dose content uniformity, particle size distribution, microscopic evaluation, 1619..
http://www.fda.gov/cder/guidance/2180dft.pdf (score=100)

FDA Concept Paper: Drug Products That Present Demonstrable Difficulties for...
...38 The packaging of the TDS is criticalfor its stability, and considerable knowledge of.....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=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 composition of an MDI formulation is crucial, particularly in defining the physical.....The recommendations for acceptance criteria and tests for emitted dose content uniformity from..
http://www.fda.gov/CDER/GUIDANCE/2180dft.htm (score=22)

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 composition of an MDI formulation is crucial, particularly in defining the physical.....The recommendations for acceptance criteria and tests for emitted dose content uniformity from..
http://www.fda.gov/cder/guidance/2180dft.htm (score=22)

stability guidance -draft
...when significant change in aerodynamic particle size distribution or in dose content uniformity.....Data other than the primary stability data, such as stability data on early synthetic.....container meeting dose content uniformity, aerodynamic particle size distribution..
http://www.fda.gov/cder/guidance/1707dft.pdf (score=13)

ENFORCEMENT REPORT FOR MARCH 24, 2000
...125 mg, repacked in unit dose blister packs (10x31) with and without a grid card, Rx.....083%, in 3 ml unit dose vials, Rx used for the prevention and relief of bronchospasm. NDC.....REASON Subpotency (at 12 month stability). RECALLS AND FIELD CORRECTIONS: BIOLOGICS..
http://www.fda.gov/bbs/topics/ENFORCE/ENF00643.html (score=13)

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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.....Expiration Dating and Stability Testing of Solid Oral Dosage Form Drugs Containing Iron (I..
http://www.fda.gov/cder/guidance/guidlist.pdf (score=4)

IND content and format for Phase 1 studies
...A brief description of the stability study and the test..methods used to monitor the.....exclusions; and a description of the dosing plan, including duration,dose, or method to be.....and the general requirements for an IND's content and format. III. CLARIFICATIONS OF..
http://www.fda.gov/cder/guidance/phase1.pdf (score=4)

Selected Guidance Documents Applicable to Combination Products
...Estimating the Safe Starting Dose in Clinical Trials for Therapeutics in Adult Healthy.....Guidance for the Content of Premarket Notifications for Conventional and Antimicrobial.....Submitting Documentation for the Stability of Human Drugs and Biologics.. Submitting..
http://www.fda.gov/oc/combination/guidance.html (score=4)

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