MDI and DPI Drug Products
...establish a set of criteria to which a drug substance or drug product should conform using.....formulation, moisture level, consistency of filling operation, particle size distribution.....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...
...Even slight changes in the formulation, drug substance particle size, valve, or actuator can have a major effect.....Other important properties of the drug substance may include particle size distribution.....A vehicle that optimally delivers one drug substance may be inappropriate for delivery of a..
http://www.fda.gov/cder/fdama/difconc.htm (score=74)

Substance
...individual batches of the drug substance used in animal and clinical testing, Drug Substance.....less than 5 milligrams per milliliter) both the typical original particle size distribution and the particle size.....Production of a drug substance, whether by synthesis, fermentation, or isolation, usually..
http://www.fda.gov/cder/guidance/drugsub.pdf (score=71)

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.....The size and even the type of granule can affect the pore size in a tablet and have an.....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=52)

GUIDE TO INSPECTIONS OF TOPICAL DRUG PRODUCTS
...Particle size can also affect the activity of the drug substance because the smaller the particle size the greater its surface area.....If the drug substance is soluble, then potency uniformity would be based largely upon adequate.....Uniformity and particle size are particularly significant where the drug substance is..
http://www.fda.gov/ora/inspect_ref/igs/topic.html (score=32)

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