...potential y expose the nursing infant to a dose of acyclovir up to 0.3 mg/kg per day.....The dose size per application will vary depending.. upon the total lesion area but should.....However, the small size of.. the registry is insufficient to evaluate the risk for less..
http://www.fda.gov/cder/foi/label/2001/18604s18lbl.pdf (score=100)

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...In rabbits, in utero fetal loss occurred at an intravenous dose of 33 mg/m2, which is 17.....dose size and approximates the normal glomerular filtration rate. The major metabolite found in.....The recommended adult dose is 500 mg BIAXIN, 30 mg lansoprazole, and 1 gram amoxicillin..
http://www.fda.gov/cder/foi/label/2000/50775lbl.pdf (score=100)

FDA Enforcement Report
...QUANTITY Lot Number Packaging Size Number Bottles SL410SU Pint Bottles 1536 SL411SU Pint.....dose blisters of 10 cards, 10 tablets per card, Rx, used in combination with other.....the lot number has various suffixes, dependent on the bottle size). MANUFACTURER Novopharm..
http://www.fda.gov/bbs/topics/ENFORCE/ENF00467.html (score=100)

FDA Enforcement Report
...PRODUCT Metoclopramide Tablets, USP 5 mg, in 5 unit dose size blister packs, Rx antiemetic.....Needles are either straight or right angle, color varies, depending on the size of the.....PRODUCT Oxygen, USP, transfilled into "E" size cylinders, under the following labels..
http://www.fda.gov/bbs/topics/ENFORCE/ENF00382.html (score=100)

MDI and DPI Drug Products
...formulation, moisture level, consistency of filling operation, particle size distribution.....the reproducibility of the dose and particle size distribution. Maintaining these.....emitted dose content uniformity, particle size distribution, microscopic evaluation, 1619..
http://www.fda.gov/cder/guidance/2180dft.pdf (score=39)

FDA Concept Paper: Drug Products That Present Demonstrable Difficulties for...
...This interaction can contribute to inconsistent dose delivery and particle size.....These interactions can contribute to inconsistent dose delivery and particle size.....Minor changes in the concentration or dose of an excipient can result in markedly..
http://www.fda.gov/cder/fdama/difconc.htm (score=34)

Document
...treatment effects nor unblinding of data and, sample size for the trial. guideline and the.....the dose of the active comparator, eligibility.. investigation of the shape and location.....be detected or rejected at the dose and in the.. investigational product is less than that..
http://www.fda.gov/cder/guidance/91698.pdf (score=34)

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...design that could unfairly favor one treatment are choice of dose or patient population.....smallest effect size that the active drug would be reliably expected to have is only.....used at too low a dose or whether the apparently less well-tolerated treatment has been..
http://www.fda.gov/cder/guidance/4155fnl.pdf (score=32)

GUIDE TO INSPECTIONS OF ORAL SOLID DOSAGE FORMS PRE/POST APPROVAL ISSUES...
...Although many firms evaluate dose uniformity using the compendial dose uniformity.....The size and even the type of granule can affect the pore size in a tablet and have an.....Different tablet compression equipment can cause dose uniformity, weight uniformity and..
http://www.fda.gov/ora/inspect_ref/igs/solid.html (score=31)

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