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=100)

stability guidance -draft
...of drug substance placed on stability should be representative of both the quality of the.....under refrigerator or freezer temperatures, or certain studies on metered dose inhalations.....this guidance to mean a batch of drug substance or drug product manufactured at the scale..
http://www.fda.gov/cder/guidance/1707dft.pdf (score=111)

WAIS Document Retrieval
...Such studies should normally be conducted on the drug product or drug substance containing the degradation.....Degradation products observed in stability studies conducted at recommended storage.....If repeat-dose studies are desirable, a maximum duration of 90 days would be acceptable..
http://www.fda.gov/cder/guidance/ichq3b.htm (score=78)

FDA Concept Paper: Drug Products That Present Demonstrable Difficulties for...
...A vehicle that optimally delivers one drug substance may be inappropriate for delivery of a.....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..
http://www.fda.gov/cder/fdama/difconc.htm (score=74)

...Stability-indicating analytical methods should be developed to monitor the stability of the drug substance and.....To support expanded clinical trials, repeat-dose toxicity of a botanical drug should.....The stability of a botanical drug substance or product generally should not be based entirely on the assay of the active..
http://www.fda.gov/cder/guidance/4592fnl.doc (score=73)

Guidance for Industry Botanical Drug Products
...These regulations require documentation of the drug substance, drug product, placebo, labeling.....The sponsor should develop stability-indicating analytical methods and conduct stability.....Because the product is marketed and the dose that is thought to be appropriate and well..
http://www.fda.gov/cder/guidance/4592fnl.htm (score=71)

Content and Format of INDs for Phase 1 Studies of Drugs, Inclu
...Food and Drug Administration, Center for Drug Evaluation and Research,"IND Process and.....Information to support the stability of the drug..substance during the toxicologic studies.....stopping or dose adjustment rules. In addition, the regulations state that..modifications..
http://www.fda.gov/cder/guidance/clin2.pdf (score=58)

IND content and format for Phase 1 studies
...As clinical development of a drug product proceeds,sponsors should discuss the.....Information to support the stability of the drug..substance during the toxicologic studies.....exclusions; and a description of the dosing plan, including duration,dose, or method to be..
http://www.fda.gov/cder/guidance/phase1.pdf (score=55)

GUIDE TO INSPECTIONS OF ORAL SOLID DOSAGE FORMS PRE/POST APPROVAL ISSUES...
...For example, micronizing or milling a drug substance and providing greater surface area of the.....Although many firms evaluate dose uniformity using the compendial dose uniformity.....The Center for Drugs conducts an evaluation of the stability data and approves the..
http://www.fda.gov/ora/inspect_ref/igs/solid.html (score=53)

GUIDE TO INSPECTIONS ORAL SOLUTIONS AND SUSPENSIONS , FDA, ORA
...Observe the addition of drug substance and powdered excipients to manufacturing vessels to.....One area that has presented a number of problems includes the assurance of stability of.....Thus, for unit dose solution products, they should deliver the label claim within the..
http://www.fda.gov/ora/inspect_ref/igs/oral.html (score=30)

Microsoft Word - 3640fnl.doc
...the proposed mechanisms by which drug substances or drug products can enhance UV-associated skin.....ultraviolet/visible radiation absorption spectrum for the drug substance or drug..formulation.....Changes in the optical properties of the skin, such as those caused by a drug vehicle, can..result in a greater UV dose to the..
http://www.fda.gov/cder/guidance/3640fnl.pdf (score=30)

Document
...foreign marketing developments with treatment use under a treatment pro-the drug during.....including, for example, information patients as early in the drug develop- about dose response, information.....A description of studies of the drug involving labora- the drug substance, including its phys- tory animals or in vitro..
http://www.fda.gov/cber/ind/21cfr312.pdf (score=28)

WAIS Document Retrieval
...FDA recognizes that modifications to the method of preparation of the new drug substance and.....For example, although stability data are required in all phases of the IND to demonstrate.....Any adverse drug experience occurring at any dose that results in any of the following outcomes: Death, a life-threatening..
http://www.fda.gov/cber/ind/21cfr312.htm (score=28)

...General Considerations for Testing a Drug Product or Drug Substance For most drugs, it is generally adequate to.....Changes in the optical properties of the skin, such as those caused by a drug vehicle, can result in a greater UV dose to the.....Maillols, 1997, "Stability of UV Filters in Different Vehicles: Solvents and Emulsions..
http://www.fda.gov/cder/guidance/3640fnl.doc (score=28)

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...Specifications for the drug substance should include tests for identity, biological activity of.....12 months at the recommended storage temperature as well as 3 months of accelerated.....A randomized withdrawal design also can be adapted to incorporate a dose-response..
http://www.fda.gov/OHRMS/DOCKETS/98fr/2003d-0206-gdl0001.pdf (score=26)

...Drug Substance For the starting material used in the manufacturing process, information on.....Stability Due to the inherent lability that has been observed with PEPs, stability data.....As a result, patients will at no time receive a much higher or lower dose than intended, a..
http://www.fda.gov/OHRMS/DOCKETS/98fr/2003d-0206-gdl0001.doc (score=25)

Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Drug Products...
...This test is useful for detection of large particles and agglomerates of the drug substance, can define morphology of drug.....The composition of an MDI formulation is crucial, particularly in defining the physical.....Metered-dose inhaler products contain therapeutically active ingredients dissolved or..
http://www.fda.gov/CDER/GUIDANCE/2180dft.htm (score=25)

Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Drug Products...
...This test is useful for detection of large particles and agglomerates of the drug substance, can define morphology of drug.....The composition of an MDI formulation is crucial, particularly in defining the physical.....Metered-dose inhaler products contain therapeutically active ingredients dissolved or..
http://www.fda.gov/cder/guidance/2180dft.htm (score=25)

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...For most drugs, it is generally acceptable to test only the drug substance for phototoxicity.....minimal erythemal dose, sunburn cell number, P53 alterations, dimer formation in DNA, and.....and their effects on the penetration of the drug substance into the skin is useful in..
http://www.fda.gov/cder/guidance/3281dft.pdf (score=25)

Guidance for Industry: Human Somatic Cell Therapy and Gene Therapy
...Murphy, HFM-17, Center for Biologics Evaluation and Research, Food and Drug Administration.....Note that if drug substance (defined as bulk product not necessarily in final formulation)and.....A no-effect level dose, an overtly toxic dose, and several intermediate..doses should be determined, and..
http://www.fda.gov/cber/gdlns/somgene.pdf (score=20)

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