MDI and DPI Drug Products
...establish a set of criteria to which a drug substance or drug product should conform using.....an internal reservoir containing sufficient formulation for multiple doses that are.....also known as oral and nasal metered dose inhalers respectively or MDIs) and inhalation..
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.....the same formulation of the dosage form in the container and closure proposed for.....under refrigerator or freezer temperatures, or certain studies on metered dose inhalations..
http://www.fda.gov/cder/guidance/1707dft.pdf (score=87)

FDA Concept Paper: Drug Products That Present Demonstrable Difficulties for...
...Even slight changes in the formulation, drug substance particle size, valve, or actuator can have a major.....Metered dose inhalers are sophisticated drug delivery systems that require extensive.....In addition, careful control of the impurities and degradation products in the drug substance and drug formulation..
http://www.fda.gov/cder/fdama/difconc.htm (score=60)

...These regulations require documentation of the drug substance, drug product, placebo, labeling.....In the case of a multi-herb substance, it is composed of the same formulation as a historical formula, with the amount of each.....To support expanded clinical trials, repeat-dose toxicity of a botanical drug should..
http://www.fda.gov/cder/guidance/4592fnl.doc (score=58)

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.....formulation and the individual botanical ingredients within the formulation must be..
http://www.fda.gov/cder/guidance/4592fnl.htm (score=56)

...Systemic exposure patterns reflect both release of the drug substance from the drug product and.....The drug product's formulation provides consistent pharmacokinetic performance between individual dosage.....For a BE determination of an oral product with a long half-life drug, a nonreplicate, single-dose, crossover study can..
http://www.fda.gov/cder/guidance/5356fnl.doc (score=42)

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.....formulation and the manufacturing and control processes. Most companies have used product..
http://www.fda.gov/ora/inspect_ref/igs/solid.html (score=41)

Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Drug Products...
...Whereas MDIs administer doses of the drug substance formulation to the patient without contamination of.....Metered-dose inhaler products contain therapeutically active ingredients dissolved or.....In the case of device-metered DPIs, the particle size distribution of the drug substance within the formulation..
http://www.fda.gov/CDER/GUIDANCE/2180dft.htm (score=39)

Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Drug Products...
...Whereas MDIs administer doses of the drug substance formulation to the patient without contamination of.....Metered-dose inhaler products contain therapeutically active ingredients dissolved or.....In the case of device-metered DPIs, the particle size distribution of the drug substance within the formulation..
http://www.fda.gov/cder/guidance/2180dft.htm (score=39)

...So, it's both involved in formulation development to find out a proper formulation for that drug substance, as well.....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.....So, that critical step is the drug substance coming out of the formulation, and as you'll see, I have a schematic of that..
http://www.fda.gov/ohrms/dockets/ac/01/transcripts/3764t1.txt (score=27)

...So, it's both involved in formulation development to find out a proper formulation for that drug substance, as well.....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.....So, that critical step is the drug substance coming out of the formulation, and as you'll see, I have a schematic of that..
http://www.fda.gov/ohrms/dockets/ac/01/transcripts/3764t1.htm (score=27)

Microsoft Word - 3640fnl.doc
...ultraviolet/visible radiation absorption spectrum for the drug substance or drug..formulation, as appropriate, is.....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.....absorption of the drug substance for one formulation do not necessarily supply relevant..data on the absorption..
http://www.fda.gov/cder/guidance/3640fnl.pdf (score=24)

...Information regarding the ultraviolet/visible radiation absorption spectrum for the drug substance or drug.....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.....Studies of dermal absorption of the drug substance for one formulation do not necessarily supply relevant data on..
http://www.fda.gov/cder/guidance/3640fnl.doc (score=22)

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=22)

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.....i) A brief description of the drug substance and the formulation, including the structural..
http://www.fda.gov/cber/ind/21cfr312.htm (score=22)

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.....If all excipients and drug substances in a formulation meet the limits given in Option 1, then these components.....The lowest dose of substance in a study or group of studies that produces biologically..
http://www.fda.gov/cber/gdlns/q3cresolvent.htm (score=20)

Guidance for Industry: Q3C Impurities: Residual Solvents
...Excipient 1 meets the Option 1 limit, but the drug substance, excipient 2, and drug product do.....solvents to be used in the synthesis and formulation of pharmaceutical products should be.....option may be applied if the daily dose is not known or fixed. If all excipients and drug..
http://www.fda.gov/cber/gdlns/q3cresolvent.pdf (score=20)

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...Specifications for the drug substance should include tests for identity, biological activity of.....compendial excipient is included in the formulation of the drug product, manufacturing and.....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=20)

þÿ
...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.....previously studied for phototoxic effects in a new formulation could also warrant testing..
http://www.fda.gov/cder/guidance/3281dft.pdf (score=20)

...Drug Substance For the starting material used in the manufacturing process, information on.....When a novel or non-novel but non-compendial excipient is included in the formulation of.....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=20)

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