MDI and DPI Drug Products
...establish a set of criteria to which a drug substance or drug product should conform using.....recommended for inclusion in the application regarding the components, manufacturing.....of each facility involved in the manufacturing of the drug substance and excipients should..
http://www.fda.gov/cder/guidance/2180dft.pdf (score=100)

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.....The performance of the valve and its compatibility with other components of the drug.....Skin temperature and moisture also influence the rate and extent of absorption of the drug..
http://www.fda.gov/cder/fdama/difconc.htm (score=75)

Premarin
...In most cases, it will be clear what components of a drug make clinically meaningful contributions to the.....drug substance at or above an apparent level of 0.1%. Guideline for Industry, Impurities in New.....Consequently, not all components that "furnish pharmacological activity or other direct..
http://www.fda.gov/cder/news/celetterjw.htm (score=14)

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