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)

/a//content.10599

http://www.fda.gov/cder/foi/label/2005/050797lbl.pdf (score=85)

...An adverse reaction is a noxious and unintended response to any dose of a drug product for.....Implementation of Proposed Content and Format Revisions to Products Approved or Submitted.....All noxious and unintended responses to a medicinal product related to any dose should be..
http://www.fda.gov/OHRMS/DOCKETS/98fr/122200a.htm (score=84)

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.....Content and Format of the Adverse Reactions Section of Labeling for Human Prescription.....The commentary should identify adverse reactions that exhibit a dose-response and describe..
http://www.fda.gov/cder/guidance/1888dft.htm (score=84)

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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.....Content and Format of INDs for Phase 1 Studies of Drugs Including Well-Characterized, 10/4..
http://www.fda.gov/cder/guidance/guidlist.pdf (score=84)

Draft Guidance for Industry Content and Format of the Adverse Reactions...
...reactions that exhibit a dose-response and describe the manner in which dose-response was.....Although this guidance seeks to bring greater consistency to the content and format of the.....guidance represents the Agency=s current thinking on the content and format of the ADVERSE..
http://www.fda.gov/cber/gdlns/cfadvers.pdf (score=83)

/a//content.17138

http://www.fda.gov/cder/foi/label/2001/19309s23lbl.pdf (score=83)

/a//content.24719

http://www.fda.gov/cder/foi/label/2001/18155s22lbl.pdf (score=83)

/a//content.11935

http://www.fda.gov/medwatch/SAFETY/2004/sep_PI/Cordarone_IV_PI.pdf (score=83)

/a//content.20278

http://www.fda.gov/cder/ogd/rld/20607s5.pdf (score=83)

/a//content.21076

http://www.fda.gov/cder/foi/label/2001/20312s16lbl.pdf (score=83)

/a//content.32732

http://www.fda.gov/cder/ogd/rld/20235_S15.pdf (score=83)

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.....Content and Format of the Adverse Reactions Section of Labeling for Human Prescription.....The commentary should identify adverse reactions that exhibit a dose-response and describe..
http://www.fda.gov/cber/gdlns/cfadvers.htm (score=82)

/a//content.12639

http://www.fda.gov/cder/foi/label/2001/19583s19lbl.pdf (score=82)

/a//content.15542

http://www.fda.gov/medWatch/SAFETY/2003/03SEP_PI/Ganite%20PI%202003.pdf (score=82)

/a//content.32537

http://www.fda.gov/medwatch/SAFETY/2004/ProtonixIV_PI.pdf (score=82)

/a//content.31851
...ALTACE should be given at an initial dose of 2.5 mg, once a day for 1 week, 5 mg, recently.....red blood cell count and hemoglobin content, white blood cell or platelet count may devel.....If the initial regimen caused undue hypotension, the dose was reduced to 1.25 mg, ALTACE..
http://www.fda.gov/medwatch/SAFETY/2004/nov_PI/Altace_PI.pdf (score=82)

/a//content.3446

http://www.fda.gov/cder/foi/label/2005/21366slr005lbl.pdf (score=82)

/a//content.16339

http://www.fda.gov/medwatch/SAFETY/2004/may_PI/Cordarone_PI.pdf (score=82)

/a//content.3505

http://www.fda.gov/medwatch/SAFETY/2003/03Feb_PI/Protonix_PI.pdf (score=82)

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