Multivariate data analysis as a semi-quantitative tool for interpretive evaluation of comparability or equivalence of aerodynamic particle size distribution profiles

AAPS PharmSciTech

Volumn 10, Issue 4, 2009, Pages 1113-1120

  Shi, Shuai ^a   Hickey, Anthony J ^a  

^a UNIVERSITY OF NORTH CAROLINA   (United States)

Author keywords

Aerodynamic particle size distribution; Monte Carlo simulation; Multivariate data analysis; Orthogonal partial least square analysis

Indexed keywords

ARTICLE; BIOEQUIVALENCE; CHI SQUARE TEST; CONTROLLED STUDY; DATA ANALYSIS; DRUG DELIVERY SYSTEM; DRY POWDER; INHALATIONAL DRUG ADMINISTRATION; INTERMETHOD COMPARISON; INTRANASAL DRUG ADMINISTRATION; METERED DOSE INHALER; MONTE CARLO METHOD; MULTIVARIATE ANALYSIS; PARTIAL LEAST SQUARES REGRESSION; PARTICLE SIZE; POWDER INHALER; PREDICTION; QUANTITATIVE ANALYSIS;

AEROSOLS; CHI-SQUARE DISTRIBUTION; LEAST-SQUARES ANALYSIS; MONTE CARLO METHOD; MULTIVARIATE ANALYSIS; PARTICLE SIZE;

EID: 75549090304     PISSN: None     EISSN: 15309932     Source Type: Journal    
DOI: 10.1208/s12249-009-9303-5     Document Type: Article

References (21)

1. WP Adams D Christopher DS Lee B Morgan Z Pan GJ Singh Y Tsong S Lyapustina 2007 Product Quality Research Institute evaluation of cascade impactor profiles of pharmaceutical aerosols, part 1: background for a statistical method AAPS PharmSciTech 8 4 10.1208/pt0801004 17408227 (Pubitemid 46193940)
2. Hickey AJ. Pulmonary drug delivery-pharmaceutical chemistry and aerosol technology. In: Wang B, Siahaan T, Soltero R, editors. Drug delivery: principles and applications. New York: Wiley; 2005. p. 341-61.
3. Hickey AJ, Kazantseva M, Garcia-Contreras L. Debugging the lungs: the use of therapeutic aerosols in the treatment of pulmonary infectious diseases. In: Smith SR, Paul-Aviles F, Liu J, editors. Pharmaceutical approaches to infectious disease therapy. Godalming: Horwood; 2002. p. 67-93.
4. Hickey AJ. Summary of common approaches to pharmaceutical aerosol administration. In: Hickey AJ, editor. Pharmaceutical inhalation aerosol technology. 2nd ed. New York: Marcel Dekker; 2004. p. 385-421. 385-421.
5. Tsong Y. Statistical comparison of particle size distribution profiles. 2004; Available at: http://pqri.org/commworking/minutes/pdfs/dptc/psdpcwg/Addl/ DC01-475116-v2-Yi-Tsong-Statistical-Archive-PQRI-Profile-Comparisons.DOC. Accessed June 22, 2007.
6. FDA/CDER. Draft guidance for industry: bioavailability and bioequivalence studies for nasal aerosols and nasal sprays for local action. Food and Drug Administration Web site. 1999; Available at: http://www.fda.gov/cder/guidance/ 2070DFT.pdf. Accessed March 28, 2007.
7. FDA. CDER. Statistical information from the June 1999 Draft Guidance and Statistical Information for In Vitro Bioequivalence Data Posted on August 18, 1999. Available at: http://www.fda.gov/cder/guidance/5383stats.pdf. Accessed January 14, 2007.
8. United States Pharmacopeial Convention. Chapter 601. Aerosols, metered-dose inhalers, and dry powder inhalers. In: USP30-NF25. Rockville, MD: USP;2007. 220-240.
9. P.P. DeLuca, Lyapustina, S. Product Quality Research Institute reports. AAPS PharmSciTech [serial online]. 2007;8:article 6.
10. PQRI APSD Profile Comparisons Working Group. SAS code implementing the chi-square ratio method. 2006; Available at: http://www.pqri.org/structure/psdp. asp. Accessed May 29, 2007. Accessed May 29, 2007.
11. D Christopher WP Adams DS Lee B Morgan Z Pan GJ Singh Y Tsong S Lyapustina 2007 Product Quality Research Institute evaluation of cascade impactor profiles of pharmaceutical aerosols, part 2: evaluation of a method for determining equivalence AAPS PharmSciTech 8 5 10.1208/pt0804090 17408228
12. PQRI Profile Comparisons Working Group. Systematic study of 38 scenarios. 2005; Available at: http://pqri.org/commworking/minutes/pdfs/dptc/psdpcwg/Addl/ 38%20Systematic%20Scenarios.pdf. Accessed November 1, 2006.
13. PQRI APSD Profile ComparisonsWorking Group. Description of the PBE approach. 2007; Available at: http://www.pqri.org/commworking/minutes/pdfs/dptc/ psdpcwg/Addl/DC01-526048-v1-PBE-Description-for-PQRI-Prof-Comp.pdf. Accessed May 29, 2007. Accessed May 29, 2007.
14. D Christopher W Adams A Amann C Bertha PR Byron W Doub C Dunbar W Hauck S Lyapustina J Mitchell B Morgan S Nichols Z Pan GJ Singh T Tougas Y Tsong R Wolff B Wyka 2007 Product Quality Research Institute evaluation of cascade impactor profiles of pharmaceutical aerosols, part 3: final report on a statistical procedure for determining equivalence AAPS PharmSciTech 8 E90 10.1208/pt0804090 18181550
15. Eriksson L, Johansson E, Kettaneh-Wold N, Trygg J, Wikstrom C, Wold S. Multi- and megavariate data analysis. Part 1. Basic principles and applications. Second Revised and Enlarged Edition. Umetrics Academy. 2006.
16. PQRI Profile Comparisons Working Group. Realistic scenarios 1-33 of 55. 2005; Available at: http://pqri.org/commworking/minutes/pdfs/dptc/psdpcwg/Addl/ Realistic%20Scenarios%201-33%20of%2055.pdf. Accessed October 19, 2006.
17. PQRI Profile Comparisons Working Group. Realistic scenarios 34-55 of 55. 2005; Available at: http://pqri.org/commworking/minutes/pdfs/dptc/psdpcwg/Addl/ Realistic%20Scenarios%2034-55%20of%2055.pdf. Accessed October 19, 2006.
18. S Rochfort 2005 Metabolomics reviewed: a new "omics" platform technology for systems biology and implications for natural products research J Nat Prod 68 1813 20 10.1021/np050255w 1:CAS:528:DC%2BD2MXhtF2htrzL 16378385 (Pubitemid 43082664)
19. RA van den Berg HC Hoefsloot JA Westerhuis AK Smilde MJ van der Werf 2006 Centering, scaling, and transformations: improving the biological information content of metabolomics data BMC Genomics 7 142 10.1186/1471-2164-7-142 16762068 (Pubitemid 44202795)
20. I Noda 2008 Scaling techniques to enhance two-dimensional correlation spectra J Mol Struct 883 216 27 10.1016/j.molstruc.2007.12.026
21. S Shi ES Ashley BD Alexander AJ Hickey 2009 Initial characterization of micafungin pulmonary delivery via two different nebulizers and multivariate data analysis of aerosol mass distribution profiles AAPS PharmSciTech 10 129 37 10.1208/s12249-009-9185-6 19189220