Recent publications by IPAC-RS working groups

Leachables & Extractables in Orally Inhaled and Nasal Drug Products (OINDP) :

Safety Thresholds and Best Practices For Extractables And Leachables In Orally Inhaled And Nasal Drug Products.  D. L. Norwood, D. Ball, J. Blanchard, L. Celado, F. DeGrazio, W. Doub, T.J. Deng, T. Feinberg, A. Hendricker, J. Hrkach, R. O. McClellan, T. McGovern, D. Paskiet, D. Porter, M. Ruberto, A. Schroeder, W. M. Vogel, Q. Wang, R. Wolff, M. Munos, L. Nagao. Submitted to FDA http://pqri.org/pdfs/LE_Recommendations_to_FDA_09-29-06.pdf    (2006)

Application of Modern Analytical Technologies to the Identification of Extractables and Leachables.  D. L. Norwood, L. Nagao, S. Lyapustina, M. Munos.  American Pharmaceutical Review, Volume 8, Number 1, pp. 78-87, 2005.

A Perspective on the Challenges of Extractables, Leachables and Materials Supply for Orally Inhaled and Nasal Drug Products.  J. Mullis, C. Stults, B. A. Falco, M. Munos, L. Nagao.  Submitted to American Pharmaceutical Review. 

Best Practices for Extractables and Leachables in Orally Inhaled and Nasal Drug Products: An Overview of the PQRI Recommendations.  D. L. Norwood, D. Paskiet, M. Ruberto, T. Feinberg, A. Schroeder, G. Poochikian, Q. Wang, T. J. Deng, F. DeGrazio, M. K. Munos, L. M. Nagao.  Submitted to Pharmaceutical Research.

Development of Safety Qualification Thresholds and Their Use in Orally Inhaled and Nasal Drug Product Evaluation.  D. Ball, J. Blanchard, D. Jacobson-Kram, R. O. McClellan, T. McGovern, D. L. Norwood, W. M. Vogel, R. Wolff, and L. Nagao.  Toxicological Sciences. Volume 97, Number 2, pp. 226–236, 2007.

Foreign Particles:

Foreign Particles Testing in Orally Inhaled and Nasal Drug Products.  J. Blanchard, J. Coleman, C. D’Abreu-Hayling, R. Ghaderi, B. Haeberlin, J. Hart, S. Jensen, R. Malcolmson, S. Mittelman, L. M. Nagao, S. Sekulic, C. Snodgrass-Pilla, M. Sundahl, G. Thompson and R. Wolff.  Pharmaceutical Research.  Volume 21, Number 12, 2137-2147, 2004.

Best Practices for Managing Quality and Safety of Foreign Particles in Orally Inhaled and Nasal Drug Products, and an Evaluation of Clinical Relevance J. Blanchard, J. Coleman, C. Crim, C. D’Abreu-Hayling, L. Fries, R. Ghaderi, B. Haeberlin, R. Malcolmson, S. Mittelman, L. Nagao, I. Saracovan, L. Shtohryn, C. Snodgrass-Pilla, M. Sundahl and R. Wolff http://www.springerlink.com/content/n07820358w6k5422/  Pharmaceutical Research (Volume 24, Number 3 / March, 2007).

Cascade Impaction:

Comparison of Two Approaches for Treating Cascade Impaction Mass Balance Measurements   B. Wyka, T. Tougas, J. Mitchell; H. Strickland, D. Christopher and S. Lyapustina J. Aerosol Med. Vol.20, No. 3, pp 236-256 (2007).

Minimizing Variability of Cascade Impaction Measurements in Inhalers and Nebulizers    M. Bonam, D. Christopher, D. Cipolla, B. Donovan, D. Goodwin, S. Holmes, S. Lyapustina, J. Mitchell,  S. Nichols, G. Pettersson, C. Quale, N. Rao, D. Singh, T. Tougas, M. Van Oort, B. Walther, B. Wyka.  Submitted to AAPS PharmSciTech.

In Vitro and In Vivo Aspects of Cascade Impactor Tests and Inhaler Performance: A Review Mitchell, J., Newman, S. and Chan, H-K. AAPS PharmSciTechnol. 2007. in press.

Product Quality Research Institute Evaluation of Cascade Impactor Profiles of Pharmaceutical Aerosols, Part 1: Background for a Statistical Method. Adams WP, Christopher D, Lee DS, Morgan B, Pan Z, Singh GJP, Tsong Y, Lyapustina S. AAPS PharmSciTech.  2007; 8(1): Article 4. DOI:  10.1208/pt0801004.

http://www.aapspharmscitech.org/default/issueView.asp?vol=08&issue=01    http://www.aapspharmscitech.org/view.asp?art=pt0801004   (2007)

Product Quality Research Institute Evaluation of Cascade Impactor Profiles of Pharmaceutical Aerosols: Part 2 - Evaluation of a Method for Determining Equivalence Christopher D, Adams WP, Lee DS, Morgan B, Pan Z, Singh GJP, Tsong Y, Lyapustina S. AAPS PharmSciTech.  2007; 8(1): Article 5. DOI: 

0.1208/pt0801005.  http://www.aapspharmscitech.org/default/issueView.asp?vol=08&issue=01  .  http://www.aapspharmscitech.org/view.asp?art=pt0801005    (2007)

Product Quality Research Institute Evaluation of Cascade Impactor Profiles of Pharmaceutical Aerosols: Part 3 – Final Report on a Statistical Procedure for Determining Equivalence.  D. Christopher, W. Adams, A. Amann, C. Bertha, P. R. Byron, W. Doub, C. Dunbar, W. Hauck, S. Lyapustina, J. P. Mitchell, B. Morgan, S. Nichols, Z. Pan, G. J. P. Singh, T. Tougas, Y. Tsong, R. Wolff, and B. Wyka  AAPS PharmSciTech. 2007; 8(4): Article 90. DOI:  10.1208/pt0804090.

http://www.aapspharmscitech.org/view.asp?art=pt0804090 . (2007). 

In vitro/in vivo comparisons in pulmonary drug delivery.  Newman, S.P. and Chan, H-K. J. Aerosol Med. 2007;20(2):211. 

Supplier Quality Control

GMP Guideline for Suppliers of OINDP Device Components https://www.signmeup.com/site/reg/register.aspx?fid=N82VGK7    (2006)

General Background Publications:

An Introduction to IPAC-RS: What the industry group does for its member companies and for you.  D. Cipolla and T. Tougas.  Inhalation 2007:1  Available online at www.inhalationmag.com  (2007)
Product Quality Research Institute Reports.  DeLuca PP, Lyapustina S.  AAPS PharmSciTech. 2007; 8(1): Article 6. http://www.aapspharmscitech.org/view.asp?art=pt0801006  .  (2007)

Addressing Regulatory Issues through Pharmaceutical Consortia S. Lyapustina, L. Nagao and M. D. Capizzi Clinical Research and Regulatory Affairs.  23 (1): 21-34 (2006). 

Manuscripts in Preparation:

Quality By Design For Analytical Methods Intended For Use With Orally Inhaled And Nasal Drug Products (OINDPS).  A. Rignall, B. Benson, D. Christopher, A. Crumpton, K. Ennis, K. Hawkins, S. Lyapustina, H. Memmesheimer, A. Parkinson, M. A. Smith, B. Wyka  Manuscript in preparation
Handbook on Evaluation of Extractables and Leachables (Book).  D. Norwood, C. Stults, eds.  Manuscript in preparation.

Development of Safety Qualification Thresholds and Their use in the Evaluation of Orally Inhaled and Nasal Drug Products (Book).  D. J. Ball and D. Norwood, Eds.  W. M. Vogel, J. Blanchard, R. Wolff, T. McGovern, R. O. McClellan, D. Jacobson-Kram, L. Nagao, Authors.  Manuscript in preparation.
Characterization of a Parametric Tolerance Interval Test Proposed by FDA S. Novick et al. Manuscript in preparation.

A Design-of-Experiments (DoE) Approach To Characterizing Sources of Variability in Cascade Impaction Particle Size Determinations   D. Christopher, S. Lyapustina, J. Quiroz, H. Strickland, L. Asking, M. Bonam, S. Holmes, J. Mitchell,  G. Pettersson, T. Tougas, B. Wyka, D. Cipolla, H. Keegstra, S. Nichols, C. Quale, M. Van Oort, B. Walther, W. Watanabe.    Manuscript in preparation.