1. FDA/CDER (2008) Draft guidance for industry “Metered dose inhaler (MDI) and dry powder inhaler (DPI) drug products chemistry, manufacturing, and controls documentation”, October 1998.
http://www.fda.gov/cder/guidance/2180dft.pdf
. Accessed September 11, 2008.
2. FDA/CDER (2008) Guidance for industry “Nasal spray and inhalation solution, suspension, and spray drug products chemistry, manufacturing, and controls documentation”. Draft: May 1999.
http://www.fda.gov/ohrms/dockets/ac/00/backgrd/3609b1k.pdf
. Accessed September 11, 2008. Final: July 2002.
http://www.fda.gov/cder/guidance/4234fnl.pdf
. Accessed September 11, 2008.
3. Murphy JR, Griffiths KL. Zero-tolerance criteria do not assure product quality. Pharm Tech 2006;30(1):52–60.
http://www.pharmtech.com/pharmtech/content/printContentPopup.jsp?id=283486
. Accessed September 11, 2008.
4. M.M. Nasr. Parametric tolerance interval test for delivered dose uniformity (DDU). Presentation to Advisory Committee for Pharmaceutical Science on 25 October 2005.
http://www.fda.gov./ohrms/dockets/ac/05/slides/2005-4187S1_13_Nasr.ppt
. Accessed September 11, 2008.
5. R. Lostritto (2005) Advisory Committee for Pharmaceutical Science Meeting (in transcripts), 25 October 2005, p. 361.
http://www.fda.gov/ohrms/dockets/ac/05/transcripts/2005-4187T1.pdf
. Accessed September 11, 2008.