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.....The guidance sets forth information that should be provided to ensure continuing drug..
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.....20 In other words, we have enough science to 21 support the likelihood of drug-drug.....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..
http://www.fda.gov/ohrms/dockets/ac/04/transcripts/4034T1.DOC (score=42)

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...Should there be a single content uniformity standard for all orally inhaled and nasal drug.....He noted that there is need for a study design that has sensitivity to dose-response, thus.....On April 26, 2000, the Orally Inhaled and Nasal Drug Products Subcommittee of the Advisory..
http://www.fda.gov/ohrms/dockets/ac/00/minutes/3609m1.pdf (score=32)

FDA Concept Paper: Drug Products That Present Demonstrable Difficulties for...
...Metered dose inhalers are sophisticated drug delivery systems that require extensive development to ensure dosing accuracy.....Generally, adequate tests measurecontent, content uniformity of the active ingredient.....In addition, careful control of the impurities and degradation products in the drug substance and drug..
http://www.fda.gov/cder/fdama/difconc.htm (score=23)

...The first, dose content uniformity through container life, our working group has recommended.....The proposal is that for assessing efficacy, you would look at a single dose of the test versus reference drug, and am I.....For the drug B and drug C, I will show one natural exposure dose-ranging study for B and for C, and..
http://www.fda.gov/ohrms/dockets/ac/01/transcripts/3764t1.txt (score=13)

FDA Updates--July-August 2004 FDA Consumer
...In addition, the agency is proposing to extend sodium content labeling requirements to OTC rectal drug products containing sodium.....Veterinarians will determine the initial treatment dose based on the dog's weight and then.....Taxotere is the first drug approved to treat prostate cancer that has shown it can help..
http://www.fda.gov/fdac/departs/2004/404_upd.html (score=13)

...The first, dose content uniformity through container life, our working group has recommended.....The proposal is that for assessing efficacy, you would look at a single dose of the test versus reference drug, and am I.....For the drug B and drug C, I will show one natural exposure dose-ranging study for B and for C, and..
http://www.fda.gov/ohrms/dockets/ac/01/transcripts/3764t1.htm (score=13)

stability guidance -draft
...when significant change in aerodynamic particle size distribution or in dose content uniformity.....should be tested for total drug substance content, degradation products, extractables, in.....container meeting dose content uniformity, aerodynamic particle size distribution..
http://www.fda.gov/cder/guidance/1707dft.pdf (score=13)

/a//content.18924
...The pharmacokinetic parameters of azithromycin capsules in plasma after a loading dose of.....Biliary excretion of azithromycin, predominantly as unchanged drug, is a major route of.....In multiple-dose clinical trials involving more than 3000 patients, three patients..
http://www.fda.gov/cder/foi/label/2001/50710s008lbl.pdf (score=5)

Content and Format of the Adverse Reactions Section of Labeling for Human...
...Data in the primary table should be derived from placebo-controlled and/or dose-response.....The ADVERSE REACTIONS section of the labeling should contain drug safety information that.....Content and Format of the Adverse Reactions Section of Labeling for Human Prescription..
http://www.fda.gov/cder/guidance/1888dft.htm (score=4)

Draft Guidance for Industry Content and Format of the Adverse Reactions...
...reporting, whether the adverse reaction rate for drug exceeds the placebo rate, extent of dose-response, extent to which the.....Although this guidance seeks to bring greater consistency to the content and format of the.....reactions that exhibit a dose-response and describe the manner in which dose-response was..
http://www.fda.gov/cber/gdlns/cfadvers.pdf (score=4)

Guidance for Industry - Content and Format of the Adverse Reactions Section...
...Data in the primary table should be derived from placebo-controlled and/or dose-response.....The ADVERSE REACTIONS section of the labeling should contain drug safety information that.....Content and Format of the Adverse Reactions Section of Labeling for Human Prescription..
http://www.fda.gov/cber/gdlns/cfadvers.htm (score=4)

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...Submitting Supporting Documentation in Drug Applications for the Manufacture of Drug.....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..
http://www.fda.gov/cder/guidance/guidlist.pdf (score=4)

...An adverse reaction is a noxious and unintended response to any dose of a drug product for which.....The Need for Revised Prescription Drug Labeling Although the format and content requirements for prescription drug labeling in.....The revised content and format requirements in the proposed rule would not apply to drug..
http://www.fda.gov/OHRMS/DOCKETS/98fr/122200a.htm (score=4)

/a//content.4827

http://www.fda.gov/cder/foi/label/2004/14214s053,055,056lbl.pdf (score=4)

/a//content.2063

http://www.fda.gov/cder/warn/2005/Crestor_letter.pdf (score=4)

IND content and format for Phase 1 studies
...As clinical development of a drug product proceeds,sponsors should discuss 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)

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