May 1997 Drug Labeling Changes
...A single oral dose of 3000 mg/kg caused diarrhea and loss of appetite in cynomolgus.....Patients taking drugs associated with drug induced methemoglobinemia such as sulfonamides.....New third paragraph - "Drug stability and safety of Intal Nebulizer Solution when mixed with..
http://www.fda.gov/medwatch/safety/1997/may97.htm (score=100)

FDA Concept Paper: Drug Products That Present Demonstrable Difficulties for...
...Factors such as drug stability in the vehicle, the specific product use, and the site of.....Metered dose inhalers are sophisticated drug delivery systems that require extensive.....38 The packaging of the TDS is criticalfor its stability, and considerable knowledge of..
http://www.fda.gov/cder/fdama/difconc.htm (score=76)

MDI and DPI Drug Products
...establish a set of criteria to which a drug substance or drug product should conform using.....manufacturing, processing, packaging, controls, stability testing, or labeling operations.....distribution, crystallinity, dose content uniformity, microbial content, and stability..
http://www.fda.gov/cder/guidance/2180dft.pdf (score=64)

Guidance for Industry: Fixed Dose Combination and Co-Packaged Drug Products...
...15 Sponsors should evaluate the stability of the drug product in the actual dispensing package as well as.....A fixed-dose combination product is one in which two or more separate drug ingredients are.....Sponsors should evaluate the stability of the drug product in the actual dispensing..
http://www.fda.gov/oc/initiatives/hiv/hivguidance.html (score=56)

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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.....Expiration Dating and Stability Testing of Solid Oral Dosage Form Drugs Containing Iron (I..
http://www.fda.gov/cder/guidance/guidlist.pdf (score=50)

FR Doc 04-4249
...The comment explained that placing a bar code on such products would present a drug stability.....For example, the physician may write a prescription for the right drug, but in the wrong dose. The pharmacist.....dose is being administered because the actual dose may be a partial dose or multiple doses..
http://www.fda.gov/OHRMS/DOCKETS/98fr/04-4249.htm (score=74)

Bar Code Label Requirements for Human Drug Products and Biological...
...The comment explained that placing a bar code on such products would present a drug stability.....For example, the physician may write a prescription for the right drug, but in the wrong dose. The pharmacist.....dose is being administered because the actual dose may be a partial dose or multiple doses..
http://www.fda.gov/cber/rules/barcodelabel.htm (score=73)

Document
...number in this manner would, code requirement, and we consider drug doses of the drug.....dose and right route of administration) authority for issuance of this regulation.....code would result in too many packages also raise drug stability issues or affect..
http://www.fda.gov/OHRMS/DOCKETS/98fr/04-4249.pdf (score=72)

X:TRANSFERGUIDANCEFINAL 807FN1.PDF
...warning statements and unit-dose packaging for solid oral drug products that contain 30 mg.....have made good faith efforts to comply with the stability testing requirements but were.....children would be reduced significantly through the use of unit-dose packaging because..
http://www.fda.gov/cder/guidance/1807fn1.pdf (score=57)

/a//content.25481
...Please refer to your supplemental new drug applications dated November 5, 1999, received.....7 dose-normalized values (to 500 mg dose), estimated by population pharmacokinetic.....that adequate information has been presented to demonstrate that the drug products are..
http://www.fda.gov/cder/ogd/rld/20635s10.pdf (score=57)

Federal Register: August 14, 1997 (Volume 62, Number 157
...A citizen petition claiming that a particular drug product is not subject to the new drug requirements of the act should be.....There is new information showing significant stability and potency problems with orally.....It is particularly important to increase the dose very gradually in patients with myxedema..
http://www.fda.gov/cder/fedreg/fr14au97-83.htm (score=55)

Stability and Dose Uniformity Evaluations of Doxycycline Solid Dosage...
...To be effective in children, the drug/food or drug/drink mixture would need to have good stability and dose uniformity and have.....Stability and Dose Uniformity Evaluations of Doxycycline Solid Dosage Tablets Ground and Mixed in Food.....Food and Drug Administration, Division of Pharmaceutical Analysis, 1114 Market St., Room..
http://www.fda.gov/cder/drug/infopage/penG_doxy/stability_tables.htm (score=54)

Human Drug Notes
...While the expiration dating assigned to such products would be based on the stability of the drug product, stability.....Furthermore, injectable drug products in multi-dose containers are generally formulated with an anti-microbial.....The primary concern with multi-dose containers is the potential for contaminating the..
http://www.fda.gov/cder/hdn/hdn995.htm (score=54)

Packaging
...Samples of a drug that are selected for stability studies should be packaged in the container/clsoure system in which.....When metered-dose valves are used, full information is also necessary with respect to.....In these early stages, the IND should also indicate that appropriate stability studies..
http://www.fda.gov/cder/guidance/package.htm (score=52)

...A parenthetical explains 13 that finished dosage form includes unit dose 14 containers, multiple dose containers and.....1 DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION CENTER FOR DRUG EVALUATION AND RESEARCH CURRENT.....This basic question can be addressed 17 very easily with studies of stability of the 18..
http://www.fda.gov/cder/regulatory/pet/0521pet.doc (score=52)

stability guidance -draft
...compromise the quality, purity, or stability of the drug substance and the resulting drug.....under refrigerator or freezer temperatures, or certain studies on metered dose inhalations.....obtained on the behavior, properties, and stability of the drug substance and the..
http://www.fda.gov/cder/guidance/1707dft.pdf (score=51)

Reaffirmation of Expiration Dating Period for Abbreviated Appl
...See "Guideline for Submitting Documentation for the Stability of Human Drugs and Biologics.....Despite this Guideline, on occasion, for injectables and products with unit dose.....To reaffirm the expiration dating period of 24 months for abbreviated new drug..
http://www.fda.gov/cder/mapp/5226-1.pdf (score=51)

...Immunoreactivity, Potency and Stability of the Immunoconjugate Coupling of toxin or drug.....The mathematical equations used to derive the estimates of the radiation dose and the absorbed dose should be.....The range of doses selected for study should include at least one dose that is equivalent to and one dose that is a multiple..
http://www.fda.gov/cber/gdlns/ptc_mab.txt (score=50)

Submission of an Investigational New Drug Application to OGD
...If a multiple-dose study is to be conducted on a controlled release drug..product on which no single dose study has been.....system(s) used in the stability tests unless other conditions are appropriate..for that.....The maximum single or total daily dose in a single dose study in normal..subjects or patients exceeds that..
http://www.fda.gov/cder/mapp/5240-4.pdf (score=50)

Guidance for Industry
...or three-drug fixed dose combination or co-packaged product with combined labeling showing.....The new information needed to support blister packaging would typically be limited to.....require the addition of low-dose ritonavir, a fourth drug component would be required and..
http://www.fda.gov/OHRMS/DOCKETS/98fr/04D-0228-GDL0001-6283dft.pdf (score=50)

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