Steering Committee
Bringing a Science-Based Approach to Regulation: The Story of the
Product Quality Research Institute
DTC
Role of Pharmacokinetics in Establishing Bioequivalence for Orally Inhaled Drug Products - Workshop Summary Report
Workshop Summary
Report
(from the Journal of Aerosol Medicine and Pulmonary Drug Delivery)
Demonstrating Bioequivalence of Locally Acting Orally Inhaled Drug Products (OIPs)
Workshop Summary
Report
(from the Journal of Aerosol Medicine and Pulmonary Drug Delivery)
Blend Uniformity
(Chair)Tom Garcia
Boehm, et.al., "Results of Statistical Analysis of Blend and Dosage Unit Content
Uniformity Data Obtained from the Product Quality Research Institute Blend Uniformity
Working Group Data-Mining Effort," PDA Journal of Pharmaceutical Science and Technology,
March/April 2004, p.62.
Boehm, et.al., "The Use of Stratified Sampling of Blend and Dosage Units to Demonstrate
Adequacy of Mix for Powder Blends," PDA Journal of Pharmaceutical Science and Technology,
Vol. 57, No. 2, March/April 2003, p. 64.
"Report on the Industry Blend Uniformity Practices Survey", Pharmaceutical Technology,
August 2001, p. 20.
The Use
of Stratified Sampling of Blend and Dosage Units to Demonstrate Adequacy of Mix
for Powder Blends (PDF)
Hancock BC, Garcia-Munoz S, "How do formulation and process parameters impact blend and unit dose uniformity?" (PDF), submitted to the Journal of Pharmaceutical Sciences.
Particle Size Distribution: Mass Balance
(Chairs) Bruce Wyka and Terry Tougas
Christopher, D., Curry, P., Doub, B., Furnkranz, K., Lavery, M., Lin, K., Lyapustina,
S., Mitchell, J., Rogers, B., Strickland, H., Tougas, T., Tsong, Y., and Wyka, B.
2003. "Considerations
for the Development and Practice of Cascade Impaction Testing, Including a Mass
Balance Failure Investigation Tree." J. Aerosol Med. 16 (3):235-247.
Mitchell, J. P. 2003. "Regarding the Development and Practice of Cascade Impaction
Testing, Including a Mass Balance Failure Investigation," J Aerosol Med. 16 (4):433.
Particle Size Distribution: Profile Comparisons (Chair) David Christopher
Manuscript in preparation, under PQRI review: "Evaluation Of A Method For Determining
Equivalence Of Cascade Impaction Profiles Of Pharmaceutical Aerosols: PQRI Working
Group’s Progress Report" by Wallace, P. A., Christopher, D., Lee, D.S., Morgan,
B., Pan, Z., Singh, G.J.P., Tsong, Y., and Lyapustina, S.
Leachables and Extractables
(Chair) Daniel Norwood
Leachables and Extractables Handbook: Safety Evaluation, Qualification, and Best Practices Applied to Inhalation Drug Products
- A Review, by John A. Budny, PharmaCal, Ltd.
Best Practices for Extractables and Leachables in Orally Inhaled
and Nasal Drug Products: An Overview of the PQRI Recommendations
Development
of Safety Qualification Thresholds and Their Use in Orally Inhaled and Nasal Drug
Product Evaluation (PDF)
Douglas Ball, James Blanchard, David Jacobson-Kram, Roger O. McClellan, Timothy
McGovern, Daniel L. Norwood, Mark Vogel, Ron Wolff, Lee Nagaott. Submitted to Toxicological
Sciences for consideration as a Review article.
Stability Shelf Life Work Group
On the Shelf Life of Pharmaceutical Products
Recommendations
L/E Recommendations
to the FDA - Cover Letter (PDF)
L/E Recommendations
to the FDA (PDF, 2MB)
Container/Closure Systems
(Chair) Daniel Malinowski
Excipients
(Chair) Robert Wiens
RFID
(Chairs) Robert Seevers and Toby Massa
Cover Story in PQRI Newsletter
Feb 2005 (PDF)
Recommendations
RFID Report to the
FDA - March 23, 2006 (PDF)
Specifications
(Chair) Angelos Dovletoglou
Impurities
(Chair) Chun Chow Chan
Physical Attributes/Particle Size of API
Sulfonate Esters
“Mechanism and Processing
Parameters Affecting the Formation of Methyl Methanesulfonate from Methanol and
Methanesulfonic Acid: An Illustrative Example for Sulfonate Ester Impurity Formation”
by Andrew Teasdale, Stephen C. Eyley, Ed Delaney, Karine Jacq, Karen Taylor-Worth,
Andrew Lipczynski, Van Reif, David P. Elder, Kevin L. Facchine, Simon Golec, Rolf
Schulte Oestrich, Pat Sandra, and Frank David. Org. Process Res. Dev. January
22, 2009.
BTC
Sequential Design Work Group
Sequential design
approaches for bioequivalence studies with crossover designs (PDF)
MTC
Specifications Design and Life Cycle Work Group
Quality by Design Specifications for Solid Oral Dosage Forms: Multivariate Product and Process Monitoring for Managing Drug Quality Attributes
Process Drift Workshop
FDA Perspectives: Detection, Measurement, and Control in Manufacturing
Risk Management Work Group
Quality Risk Management Principles and Industry Case Studies - December
28, 2008 (PDF)
Case Studies:
Training Guides:
Process Robustness Work Group
Process Robustness –
A PQRI White Paper (PDF)
Team Biologics Work Group
Results of a Survey
of Biological Drug and Device Industries Inspected by FDA under the Team Biologics
Program (PDF)
Transdermals
Passive Transdermal Systems Whitepaper Incorporating Current Chemistry, Manufacturing and Controls (CMC) Development Principles
Glenn A. Van Buskirk, Daniel Arsulowicz2 Prabir Basu, Lawrence Block, Bing Cai, Gary W. Cleary,
Tapash Ghosh, Mario A. González, David Kanios, Margareth Marques, Patrick K. Noonan,
Terrance Ocheltree, Peter Schwarz, Vinod Shah, Thomas S. Spencer, Lino Tavares, Katherine Ulman,
Rajendra Uppoor, and Thean Yeoh;
AAPS PharmSciTech (# 2011)
DOI: 10.1208/s12249-011-9740-9
The Post Approval Changes for Sterile Products WG
Post Approval Changes for
Sterile Products Working Group (PDF)
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