MDI and DPI Drug Products
...The guidance sets forth information that should be provided to ensure continuing drug.....an internal reservoir containing sufficient formulation for multiple doses that are.....manufacturing, processing, packaging, controls, stability testing, or labeling operations..
http://www.fda.gov/cder/guidance/2180dft.pdf (score=100)

FDA Concept Paper: Drug Products That Present Demonstrable Difficulties for...
...For these reasons, the drug formulation of a TDS product, including the interaction of all TDS components, is highly.....Factors such as drug stability in the vehicle, the specific product use, and the site of.....The composition of an MDI formulation and the physicochemical content of each of the formulation..
http://www.fda.gov/cder/fdama/difconc.htm (score=59)

Microsoft Word - 3640fnl.doc
...For topical products that will be applied to sun-exposed skin, FDA recommends that the drug.....photoallergy studies in humans, should be considered for all drug substances and..formulation components that absorb UVB.....Maillols, 1997, "Stability of UV Filters in Different Vehicles: Solvents and Emulsions..
http://www.fda.gov/cder/guidance/3640fnl.pdf (score=40)

...Information regarding the ultraviolet/visible radiation absorption spectrum for the drug substance or drug.....A photoactive chemical can be the parent drug or an excipient in a drug product, or it can be a metabolite, impurity, or.....Maillols, 1997, "Stability of UV Filters in Different Vehicles: Solvents and Emulsions..
http://www.fda.gov/cder/guidance/3640fnl.doc (score=38)

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...5 The 1987 stability guidance will be superseded by FDA's draft guidance for industry Stability Testing of Drug.....The quality and purity of the lipid components can affect the quality of the liposome drug.....2 A liposomal formulation of an active moiety that has already been approved or marketed..
http://www.fda.gov/cder/guidance/2191dft.pdf (score=33)

Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Drug Products...
...Appropriate acceptance criteria should be instituted for the appearance of the drug product formulation.....The performance of the valve and its compatibility with other drug product components should be.....The composition of the formulation of a DPI has a direct effect on the stability of the..
http://www.fda.gov/CDER/GUIDANCE/2180dft.htm (score=32)

Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Drug Products...
...Appropriate acceptance criteria should be instituted for the appearance of the drug product formulation.....The performance of the valve and its compatibility with other drug product components should be.....The composition of the formulation of a DPI has a direct effect on the stability of the..
http://www.fda.gov/cder/guidance/2180dft.htm (score=32)

PET Drug Products … Current Good Manufacturing Practice (CGMP)
...ensure that each batch of PET drug product meets its established acceptance criteria, 1201.....accelerator operation, radiochemical synthesis, purification steps, and formulation of the.....stability parameters include radiochemical identity and purity, appearance, pH, stabilizer..
http://www.fda.gov/cder/guidance/4259dft.pdf (score=23)

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