Biomedical Engineering Reference
In-Depth Information
3. Newman SP, Chan H K (2008) In vitro / In vivo comparisons in pulmonary drug delivery.
J Aerosol Med 21(1):1-8
4. International Conference on Harmonization of Technical Requirements for Registration of
Pharmaceuticals for Human Use (ICH) (2009) Q8(R2): pharmaceutical development. http://
www.ich.org/products/guidelines/quality/article/quality-guidelines.html . Accessed 20 Jan
2012
5. US Food and Drug Administration (FDA) (1998) CDER. Draft guidance for industry metered
dose inhaler (MDI) and dry powder inhaler (DPI) drug products chemistry, manufacturing, and
controls documentation, Rockville, MD, USA. http://www.fda.gov/cder/guidance/2180dft.
pdf . Accessed 6 Jan 2012
6. US Food and Drug Administration (FDA) (1993) CDRH. Reviewer guidance for nebulizers,
metered dose inhalers, spacers and actuators, Rockville, MD, USA. http://www.fda.gov/
downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/
ucm081293.pdf . Accessed 20 Jan 2012
7. Marple VA, Roberts DL, Romay FJ, Miller NC, Truman KG, Van Oort M, Olsson B, Holroyd
MJ, Mitchell JP, Hochrainer D (2003) Next generation pharmaceutical impactor - Part I:
Design. J Aerosol Med 16(3):283-299
8. Adams WP, Christopher D, Lee DS, Morgan P, Pan Z, Singh GJP, Tsong Y, Lyapustina S
(2007) Product quality research institute (PQRI) evaluation of cascade impactor profi les of
pharmaceutical aerosols, Part 1: Background for a statistical method. AAPS PharmSciTech
8(1): article 4. http://www.aapspharmscitech.org/articles/pt0801/pt0801004/pt0801004.pdf .
Accessed 20 Jan 2012
9. European Medicines Agency (EMA) (2006) Guideline on the pharmaceutical quality of inha-
lation and nasal products. London, UK, EMEA/CHMP/QWP/49313/2005 Final. http://www.
ema.europa.eu/pdfs/human/qwp/4931305en.pdf . Accessed 20 Jan 2012
10. Health Canada (2006) Guidance for industry: pharmaceutical quality of inhalation and nasal
products. File Number fi le number: 06-106624-547. http://www.hc-sc.gc.ca/dhp-mps/alt_
formats/hpfb-dgpsa/pdf/prodpharma/inhalationnas-eng.pdf . Accessed 20 Jan 2012
11. European Directorate for the Quality of Medicines and Healthcare (EDQM) (2012)
Preparations for inhalation: aerodynamic assessment of fi ne particles. Section 2.9.18 - European
Pharmacopeia, Council of Europe, Strasbourg, France
12. European Medicines Agency (EMA) (2008) Overall summary of the scientifi c evaluation of
Salbumalin and associated names. http://www.ema.europa.eu/docs/en_GB/document_library/
Referrals_document/Sabumalin_29/WC500007491.pdf . Accessed 27 Jan 2012
13. Bonam M, Christopher D, Cipolla D, Donovan B, Goodwin D, Holmes S, Lyapustina S,
Mitchell J, Nichols S, Petterson G, Quale C, Rao N, Singh D, Tougas T, Van Oort M, Walther
B, Wyka B (2008) Minimizing variability of cascade impaction measurements in inhalers and
nebulizers. AAPS PharmSciTech 9(2):404-413
14. Christopher D, Curry P, Doub B, Furnkranz K, Lavery M, Lin K, Lyapustina S, Mitchell J,
Rogers B, Strickland H, Tougas T, Tsong Y, Wyka B (2003) Considerations for the develop-
ment and practice of cascade impaction testing including a mass balance failure investigation
tree. J Aerosol Med 16:235-247
15. Mitchell JP (2008) The abbreviated impactor measurement (AIM) concept for aerodynamic
particle size distribution (APSD) in a quality-by-design (QbD) environment. Presentation at
IPAC-RS Conference, 2008. http://www.ipacrs.com/PDFs/IPAC-RS%202008%20Conference/
Day%203/5-%20IPAC-RS%20Conference%202008%20-%20Jolyon%20Mitchell.pdf.
Accessed 20 Jan 2012
16. Mitchell JP, Nagel MW (2003) Cascade impactors for the size characterization of aerosols
from medical inhalers: their use and limitations. J Aerosol Med 16(3):341-377
17. Stein SW (2008) Aiming for a moving target: challenges with impactor measurements of MDI
aerosols. Int J Pharm 355(1-2):53-61
18. Bosquillon C, Lombry C, Préat V, Vanbever R (2001) Infl uence of formulation excipients and
physical characteristics of inhalation dry powders on their aerosolization performance. J Contr
Rel 70(3):329-339
Search WWH ::




Custom Search