MDI and DPI Drug Products
...establish a set of criteria to which a drug substance or drug product should conform using.....also known as oral and nasal metered dose inhalers respectively or MDIs) and inhalation.....of each facility involved in the manufacturing of the drug substance and excipients should..
http://www.fda.gov/cder/guidance/2180dft.pdf (score=100)

stability guidance -draft
...this guidance to mean a batch of drug substance or drug product manufactured at the scale.....under refrigerator or freezer temperatures, or certain studies on metered dose inhalations.....process of a drug substance or drug product is made, sufficient data to show that such a change..
http://www.fda.gov/cder/guidance/1707dft.pdf (score=117)

Guidance- Content & Format CMC for Vaccine & Related Product
...A list should be provided of all components in the drug product, including drug substance(s)and other ingredients, with.....preservative in single dose drug products. The results of the preservative effectiveness.....trials materials and commercial production batches of drug substance and drug product should be..
http://www.fda.gov/cber/gdlns/cmcvacc.pdf (score=88)

WAIS Document Retrieval
...Such studies should normally be conducted on the drug product or drug substance containing the degradation.....If repeat-dose studies are desirable, a maximum duration of 90 days would be acceptable.....Safety studies should provide a comparison of results of safety testing of the drug product or drug substance..
http://www.fda.gov/cder/guidance/ichq3b.htm (score=79)

...These regulations require documentation of the drug substance, drug product, placebo, labeling.....To support expanded clinical trials, repeat-dose toxicity of a botanical drug should.....one in which the components or ingredients and composition of the drug substance and drug..
http://www.fda.gov/cder/guidance/4592fnl.doc (score=73)

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.....Metered dose inhalers are sophisticated drug delivery systems that require extensive.....Skin temperature and moisture also influence the rate and extent of absorption of the drug..
http://www.fda.gov/cder/fdama/difconc.htm (score=73)

Guidance for Industry Botanical Drug Products
...These regulations require documentation of the drug substance, drug product, placebo, labeling.....Because the product is marketed and the dose that is thought to be appropriate and well.....one in which the components or ingredients and composition of the drug substance and drug..
http://www.fda.gov/cder/guidance/4592fnl.htm (score=70)

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.....of the IND to demonstrate that the new drug substance and drug product..are within acceptable.....stopping or dose adjustment rules. In addition, the regulations state that..modifications..
http://www.fda.gov/cder/guidance/clin2.pdf (score=56)

IND content and format for Phase 1 studies
...As clinical development of a drug product proceeds,sponsors should discuss the.....drug substance and drug product are within acceptable chemical and..physical limits for the.....exclusions; and a description of the dosing plan, including duration,dose, or method to be..
http://www.fda.gov/cder/guidance/phase1.pdf (score=53)

...Systemic exposure patterns reflect both release of the drug substance from the drug product and.....For a BE determination of an oral product with a long half-life drug, a nonreplicate, single-dose, crossover study can.....BA data can also provide information indirectly about the properties of a drug substance before..
http://www.fda.gov/cder/guidance/5356fnl.doc (score=50)

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.....Characterization of the chemical and physical properties of the drug substance is one of the..
http://www.fda.gov/ora/inspect_ref/igs/solid.html (score=50)

...Well, this is another study with the same active drug substance, drug B, and there are two.....For the drug B and drug C, I will show one natural exposure dose-ranging study for B and for C, and then I'll also show a study.....We're talking about the exact same drug substance in the exact same form for the exact same use..
http://www.fda.gov/ohrms/dockets/ac/01/transcripts/3764t1.txt (score=27)

...Well, this is another study with the same active drug substance, drug B, and there are two.....For the drug B and drug C, I will show one natural exposure dose-ranging study for B and for C, and then I'll also show a study.....We're talking about the exact same drug substance in the exact same form for the exact same use..
http://www.fda.gov/ohrms/dockets/ac/01/transcripts/3764t1.htm (score=27)

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=24)

GUIDE TO INSPECTIONS ORAL SOLUTIONS AND SUSPENSIONS , FDA, ORA
...Observe the addition of drug substance and powdered excipients to manufacturing vessels to.....Thus, for unit dose solution products, they should deliver the label claim within the.....The physical characteristics, particularly the particle size of the drug substance, are very..
http://www.fda.gov/ora/inspect_ref/igs/oral.html (score=24)

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=21)

WAIS Document Retrieval
...FDA recognizes that modifications to the method of preparation of the new drug substance and.....Any adverse drug experience occurring at any dose that results in any of the following outcomes: Death, a life-threatening.....If an investigational new drug is a substance listed in any schedule of the Controlled Substances..
http://www.fda.gov/cber/ind/21cfr312.htm (score=21)

...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.....Information regarding the ultraviolet/visible radiation absorption spectrum for the drug..
http://www.fda.gov/cder/guidance/3640fnl.doc (score=21)

Guidance for Industry - Content and Format of Chemistry, Manufacturing and...
...This section of the guidance refers to drug substances derived from another drug substance or intermediate through chemical or.....A rationale should be provided for the inclusion of a preservative in single dose drug products.....The quality and purity of the drug substance cannot be assured solely by downstream testing..
http://www.fda.gov/cber/gdlns/cmcvacc.htm (score=21)

Guidance for Industry: Q3C Impurities: Residual Solvents
...meets the Option 1 limit, but the drug substance, excipient 2, and drug product do not meet the.....The lowest dose of substance in a study or group of studies that produces biologically.....Appropriate selection of the solvent for the synthesis of drug substance may enhance the yield..
http://www.fda.gov/cber/gdlns/q3cresolvent.htm (score=18)

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