Index by Author

September/October 2013; Volume 67,Issue 5

A

  1. Annalaura, Carducci

    1. The Application of Quality Risk Management to the Bacterial Endotoxins Test: Use of Hazard Analysis and Critical Control Points
      Carducci Annalaura, Davini Giulia and Ceccanti Stefano
      PDA Journal of Pharmaceutical Science and Technology September 2013, 67 (5) 553-567; DOI: https://doi.org/10.5731/pdajpst.2013.00938

B

  1. Ball, Douglas

    1. The Product Quality Research Institute (PQRI) Leachables and Extractables Working Group Initiatives for Parenteral and Ophthalmic Drug Product (PODP)
      Diane Paskiet, Dennis Jenke, Douglas Ball, Christopher Houston, Daniel L. Norwood and Ingrid Markovic
      PDA Journal of Pharmaceutical Science and Technology September 2013, 67 (5) 430-447; DOI: https://doi.org/10.5731/pdajpst.2013.00936

C

  1. Castner, James

    1. Extractables Characterization for Five Materials of Construction Representative of Packaging Systems Used for Parenteral and Ophthalmic Drug Products
      Dennis Jenke, James Castner, Thomas Egert, Tom Feinberg, Alan Hendricker, Christopher Houston, Desmond G. Hunt, Michael Lynch, Arthur Shaw, Kumudini Nicholas, Daniel L. Norwood, Diane Paskiet, Michael Ruberto, Edward J. Smith and Frank Holcomb
      PDA Journal of Pharmaceutical Science and Technology September 2013, 67 (5) 448-511; DOI: https://doi.org/10.5731/pdajpst.2013.00933

  2. Cheng, Yujie

    1. Application of the Finite Elemental Analysis to Modeling Temperature Change of the Vaccine in an Insulated Packaging Container during Transport
      Changfeng Ge, Yujie Cheng and Yan Shen
      PDA Journal of Pharmaceutical Science and Technology September 2013, 67 (5) 544-552; DOI: https://doi.org/10.5731/pdajpst.2013.00937

D

  1. Dehmler, Matthew A.

    1. Evaluation of a Rapid Microbiological Method with a Mixed Culture Biofilm Model
      Patrick J. McCormick, Michael J. Schoene, Matthew A. Dehmler, James J. Kaiser, Susan E. Norton, Alexandre Pizon and Mark A. Fornalik
      PDA Journal of Pharmaceutical Science and Technology September 2013, 67 (5) 512-532; DOI: https://doi.org/10.5731/pdajpst.2013.00932

E

  1. Egert, Thomas

    1. Extractables Characterization for Five Materials of Construction Representative of Packaging Systems Used for Parenteral and Ophthalmic Drug Products
      Dennis Jenke, James Castner, Thomas Egert, Tom Feinberg, Alan Hendricker, Christopher Houston, Desmond G. Hunt, Michael Lynch, Arthur Shaw, Kumudini Nicholas, Daniel L. Norwood, Diane Paskiet, Michael Ruberto, Edward J. Smith and Frank Holcomb
      PDA Journal of Pharmaceutical Science and Technology September 2013, 67 (5) 448-511; DOI: https://doi.org/10.5731/pdajpst.2013.00933

F

  1. Feinberg, Tom

    1. Extractables Characterization for Five Materials of Construction Representative of Packaging Systems Used for Parenteral and Ophthalmic Drug Products
      Dennis Jenke, James Castner, Thomas Egert, Tom Feinberg, Alan Hendricker, Christopher Houston, Desmond G. Hunt, Michael Lynch, Arthur Shaw, Kumudini Nicholas, Daniel L. Norwood, Diane Paskiet, Michael Ruberto, Edward J. Smith and Frank Holcomb
      PDA Journal of Pharmaceutical Science and Technology September 2013, 67 (5) 448-511; DOI: https://doi.org/10.5731/pdajpst.2013.00933

  2. Fornalik, Mark A.

    1. Evaluation of a Rapid Microbiological Method with a Mixed Culture Biofilm Model
      Patrick J. McCormick, Michael J. Schoene, Matthew A. Dehmler, James J. Kaiser, Susan E. Norton, Alexandre Pizon and Mark A. Fornalik
      PDA Journal of Pharmaceutical Science and Technology September 2013, 67 (5) 512-532; DOI: https://doi.org/10.5731/pdajpst.2013.00932

G

  1. Ge, Changfeng

    1. Application of the Finite Elemental Analysis to Modeling Temperature Change of the Vaccine in an Insulated Packaging Container during Transport
      Changfeng Ge, Yujie Cheng and Yan Shen
      PDA Journal of Pharmaceutical Science and Technology September 2013, 67 (5) 544-552; DOI: https://doi.org/10.5731/pdajpst.2013.00937

  2. Giulia, Davini

    1. The Application of Quality Risk Management to the Bacterial Endotoxins Test: Use of Hazard Analysis and Critical Control Points
      Carducci Annalaura, Davini Giulia and Ceccanti Stefano
      PDA Journal of Pharmaceutical Science and Technology September 2013, 67 (5) 553-567; DOI: https://doi.org/10.5731/pdajpst.2013.00938

H

  1. Hendricker, Alan

    1. Extractables Characterization for Five Materials of Construction Representative of Packaging Systems Used for Parenteral and Ophthalmic Drug Products
      Dennis Jenke, James Castner, Thomas Egert, Tom Feinberg, Alan Hendricker, Christopher Houston, Desmond G. Hunt, Michael Lynch, Arthur Shaw, Kumudini Nicholas, Daniel L. Norwood, Diane Paskiet, Michael Ruberto, Edward J. Smith and Frank Holcomb
      PDA Journal of Pharmaceutical Science and Technology September 2013, 67 (5) 448-511; DOI: https://doi.org/10.5731/pdajpst.2013.00933

  2. Holcomb, Frank

    1. Extractables Characterization for Five Materials of Construction Representative of Packaging Systems Used for Parenteral and Ophthalmic Drug Products
      Dennis Jenke, James Castner, Thomas Egert, Tom Feinberg, Alan Hendricker, Christopher Houston, Desmond G. Hunt, Michael Lynch, Arthur Shaw, Kumudini Nicholas, Daniel L. Norwood, Diane Paskiet, Michael Ruberto, Edward J. Smith and Frank Holcomb
      PDA Journal of Pharmaceutical Science and Technology September 2013, 67 (5) 448-511; DOI: https://doi.org/10.5731/pdajpst.2013.00933

  3. Houston, Christopher

    1. The Product Quality Research Institute (PQRI) Leachables and Extractables Working Group Initiatives for Parenteral and Ophthalmic Drug Product (PODP)
      Diane Paskiet, Dennis Jenke, Douglas Ball, Christopher Houston, Daniel L. Norwood and Ingrid Markovic
      PDA Journal of Pharmaceutical Science and Technology September 2013, 67 (5) 430-447; DOI: https://doi.org/10.5731/pdajpst.2013.00936
    2. Extractables Characterization for Five Materials of Construction Representative of Packaging Systems Used for Parenteral and Ophthalmic Drug Products
      Dennis Jenke, James Castner, Thomas Egert, Tom Feinberg, Alan Hendricker, Christopher Houston, Desmond G. Hunt, Michael Lynch, Arthur Shaw, Kumudini Nicholas, Daniel L. Norwood, Diane Paskiet, Michael Ruberto, Edward J. Smith and Frank Holcomb
      PDA Journal of Pharmaceutical Science and Technology September 2013, 67 (5) 448-511; DOI: https://doi.org/10.5731/pdajpst.2013.00933

  4. Hunt, Desmond G.

    1. Extractables Characterization for Five Materials of Construction Representative of Packaging Systems Used for Parenteral and Ophthalmic Drug Products
      Dennis Jenke, James Castner, Thomas Egert, Tom Feinberg, Alan Hendricker, Christopher Houston, Desmond G. Hunt, Michael Lynch, Arthur Shaw, Kumudini Nicholas, Daniel L. Norwood, Diane Paskiet, Michael Ruberto, Edward J. Smith and Frank Holcomb
      PDA Journal of Pharmaceutical Science and Technology September 2013, 67 (5) 448-511; DOI: https://doi.org/10.5731/pdajpst.2013.00933

J

  1. Jenke, Dennis

    1. The Product Quality Research Institute (PQRI) Leachables and Extractables Working Group Initiatives for Parenteral and Ophthalmic Drug Product (PODP)
      Diane Paskiet, Dennis Jenke, Douglas Ball, Christopher Houston, Daniel L. Norwood and Ingrid Markovic
      PDA Journal of Pharmaceutical Science and Technology September 2013, 67 (5) 430-447; DOI: https://doi.org/10.5731/pdajpst.2013.00936
    2. Extractables Characterization for Five Materials of Construction Representative of Packaging Systems Used for Parenteral and Ophthalmic Drug Products
      Dennis Jenke, James Castner, Thomas Egert, Tom Feinberg, Alan Hendricker, Christopher Houston, Desmond G. Hunt, Michael Lynch, Arthur Shaw, Kumudini Nicholas, Daniel L. Norwood, Diane Paskiet, Michael Ruberto, Edward J. Smith and Frank Holcomb
      PDA Journal of Pharmaceutical Science and Technology September 2013, 67 (5) 448-511; DOI: https://doi.org/10.5731/pdajpst.2013.00933

K

  1. Kaiser, James J.

    1. Evaluation of a Rapid Microbiological Method with a Mixed Culture Biofilm Model
      Patrick J. McCormick, Michael J. Schoene, Matthew A. Dehmler, James J. Kaiser, Susan E. Norton, Alexandre Pizon and Mark A. Fornalik
      PDA Journal of Pharmaceutical Science and Technology September 2013, 67 (5) 512-532; DOI: https://doi.org/10.5731/pdajpst.2013.00932

L

  1. Lynch, Michael

    1. Extractables Characterization for Five Materials of Construction Representative of Packaging Systems Used for Parenteral and Ophthalmic Drug Products
      Dennis Jenke, James Castner, Thomas Egert, Tom Feinberg, Alan Hendricker, Christopher Houston, Desmond G. Hunt, Michael Lynch, Arthur Shaw, Kumudini Nicholas, Daniel L. Norwood, Diane Paskiet, Michael Ruberto, Edward J. Smith and Frank Holcomb
      PDA Journal of Pharmaceutical Science and Technology September 2013, 67 (5) 448-511; DOI: https://doi.org/10.5731/pdajpst.2013.00933

M

  1. Markovic, Ingrid

    1. The Product Quality Research Institute (PQRI) Leachables and Extractables Working Group Initiatives for Parenteral and Ophthalmic Drug Product (PODP)
      Diane Paskiet, Dennis Jenke, Douglas Ball, Christopher Houston, Daniel L. Norwood and Ingrid Markovic
      PDA Journal of Pharmaceutical Science and Technology September 2013, 67 (5) 430-447; DOI: https://doi.org/10.5731/pdajpst.2013.00936

  2. McCormick, Patrick J.

    1. Evaluation of a Rapid Microbiological Method with a Mixed Culture Biofilm Model
      Patrick J. McCormick, Michael J. Schoene, Matthew A. Dehmler, James J. Kaiser, Susan E. Norton, Alexandre Pizon and Mark A. Fornalik
      PDA Journal of Pharmaceutical Science and Technology September 2013, 67 (5) 512-532; DOI: https://doi.org/10.5731/pdajpst.2013.00932

N

  1. Nagao, Lee M.

    1. Perspectives on the PQRI Extractables and Leachables “Safety Thresholds and Best Practices” Recommendations for Inhalation Drug Products
      Daniel L. Norwood, Lee M. Nagao and Cheryl L. M. Stults
      PDA Journal of Pharmaceutical Science and Technology September 2013, 67 (5) 413-429; DOI: https://doi.org/10.5731/pdajpst.2013.00934

  2. Nicholas, Kumudini

    1. Extractables Characterization for Five Materials of Construction Representative of Packaging Systems Used for Parenteral and Ophthalmic Drug Products
      Dennis Jenke, James Castner, Thomas Egert, Tom Feinberg, Alan Hendricker, Christopher Houston, Desmond G. Hunt, Michael Lynch, Arthur Shaw, Kumudini Nicholas, Daniel L. Norwood, Diane Paskiet, Michael Ruberto, Edward J. Smith and Frank Holcomb
      PDA Journal of Pharmaceutical Science and Technology September 2013, 67 (5) 448-511; DOI: https://doi.org/10.5731/pdajpst.2013.00933

  3. Norton, Susan E.

    1. Evaluation of a Rapid Microbiological Method with a Mixed Culture Biofilm Model
      Patrick J. McCormick, Michael J. Schoene, Matthew A. Dehmler, James J. Kaiser, Susan E. Norton, Alexandre Pizon and Mark A. Fornalik
      PDA Journal of Pharmaceutical Science and Technology September 2013, 67 (5) 512-532; DOI: https://doi.org/10.5731/pdajpst.2013.00932

  4. Norwood, Daniel L.

    1. The Product Quality Research Institute (PQRI) Leachables and Extractables Working Group Initiatives for Parenteral and Ophthalmic Drug Product (PODP)
      Diane Paskiet, Dennis Jenke, Douglas Ball, Christopher Houston, Daniel L. Norwood and Ingrid Markovic
      PDA Journal of Pharmaceutical Science and Technology September 2013, 67 (5) 430-447; DOI: https://doi.org/10.5731/pdajpst.2013.00936
    2. Extractables Characterization for Five Materials of Construction Representative of Packaging Systems Used for Parenteral and Ophthalmic Drug Products
      Dennis Jenke, James Castner, Thomas Egert, Tom Feinberg, Alan Hendricker, Christopher Houston, Desmond G. Hunt, Michael Lynch, Arthur Shaw, Kumudini Nicholas, Daniel L. Norwood, Diane Paskiet, Michael Ruberto, Edward J. Smith and Frank Holcomb
      PDA Journal of Pharmaceutical Science and Technology September 2013, 67 (5) 448-511; DOI: https://doi.org/10.5731/pdajpst.2013.00933
    3. Perspectives on the PQRI Extractables and Leachables “Safety Thresholds and Best Practices” Recommendations for Inhalation Drug Products
      Daniel L. Norwood, Lee M. Nagao and Cheryl L. M. Stults
      PDA Journal of Pharmaceutical Science and Technology September 2013, 67 (5) 413-429; DOI: https://doi.org/10.5731/pdajpst.2013.00934

P

  1. Paskiet, Diane

    1. The Product Quality Research Institute (PQRI) Leachables and Extractables Working Group Initiatives for Parenteral and Ophthalmic Drug Product (PODP)
      Diane Paskiet, Dennis Jenke, Douglas Ball, Christopher Houston, Daniel L. Norwood and Ingrid Markovic
      PDA Journal of Pharmaceutical Science and Technology September 2013, 67 (5) 430-447; DOI: https://doi.org/10.5731/pdajpst.2013.00936
    2. Extractables Characterization for Five Materials of Construction Representative of Packaging Systems Used for Parenteral and Ophthalmic Drug Products
      Dennis Jenke, James Castner, Thomas Egert, Tom Feinberg, Alan Hendricker, Christopher Houston, Desmond G. Hunt, Michael Lynch, Arthur Shaw, Kumudini Nicholas, Daniel L. Norwood, Diane Paskiet, Michael Ruberto, Edward J. Smith and Frank Holcomb
      PDA Journal of Pharmaceutical Science and Technology September 2013, 67 (5) 448-511; DOI: https://doi.org/10.5731/pdajpst.2013.00933

  2. Pizon, Alexandre

    1. Evaluation of a Rapid Microbiological Method with a Mixed Culture Biofilm Model
      Patrick J. McCormick, Michael J. Schoene, Matthew A. Dehmler, James J. Kaiser, Susan E. Norton, Alexandre Pizon and Mark A. Fornalik
      PDA Journal of Pharmaceutical Science and Technology September 2013, 67 (5) 512-532; DOI: https://doi.org/10.5731/pdajpst.2013.00932

R

  1. Rao, Govind

    1. Waiter, There Is a Fly in My Soup!
      Govind Rao
      PDA Journal of Pharmaceutical Science and Technology September 2013, 67 (5) 412; DOI: https://doi.org/10.5731/pdajpst.2013.00949

  2. Ruberto, Michael

    1. Extractables Characterization for Five Materials of Construction Representative of Packaging Systems Used for Parenteral and Ophthalmic Drug Products
      Dennis Jenke, James Castner, Thomas Egert, Tom Feinberg, Alan Hendricker, Christopher Houston, Desmond G. Hunt, Michael Lynch, Arthur Shaw, Kumudini Nicholas, Daniel L. Norwood, Diane Paskiet, Michael Ruberto, Edward J. Smith and Frank Holcomb
      PDA Journal of Pharmaceutical Science and Technology September 2013, 67 (5) 448-511; DOI: https://doi.org/10.5731/pdajpst.2013.00933

S

  1. Schoene, Michael J.

    1. Evaluation of a Rapid Microbiological Method with a Mixed Culture Biofilm Model
      Patrick J. McCormick, Michael J. Schoene, Matthew A. Dehmler, James J. Kaiser, Susan E. Norton, Alexandre Pizon and Mark A. Fornalik
      PDA Journal of Pharmaceutical Science and Technology September 2013, 67 (5) 512-532; DOI: https://doi.org/10.5731/pdajpst.2013.00932

  2. Shaw, Arthur

    1. Extractables Characterization for Five Materials of Construction Representative of Packaging Systems Used for Parenteral and Ophthalmic Drug Products
      Dennis Jenke, James Castner, Thomas Egert, Tom Feinberg, Alan Hendricker, Christopher Houston, Desmond G. Hunt, Michael Lynch, Arthur Shaw, Kumudini Nicholas, Daniel L. Norwood, Diane Paskiet, Michael Ruberto, Edward J. Smith and Frank Holcomb
      PDA Journal of Pharmaceutical Science and Technology September 2013, 67 (5) 448-511; DOI: https://doi.org/10.5731/pdajpst.2013.00933

  3. Shen, Yan

    1. Application of the Finite Elemental Analysis to Modeling Temperature Change of the Vaccine in an Insulated Packaging Container during Transport
      Changfeng Ge, Yujie Cheng and Yan Shen
      PDA Journal of Pharmaceutical Science and Technology September 2013, 67 (5) 544-552; DOI: https://doi.org/10.5731/pdajpst.2013.00937

  4. Smith, Edward J.

    1. Extractables Characterization for Five Materials of Construction Representative of Packaging Systems Used for Parenteral and Ophthalmic Drug Products
      Dennis Jenke, James Castner, Thomas Egert, Tom Feinberg, Alan Hendricker, Christopher Houston, Desmond G. Hunt, Michael Lynch, Arthur Shaw, Kumudini Nicholas, Daniel L. Norwood, Diane Paskiet, Michael Ruberto, Edward J. Smith and Frank Holcomb
      PDA Journal of Pharmaceutical Science and Technology September 2013, 67 (5) 448-511; DOI: https://doi.org/10.5731/pdajpst.2013.00933

  5. Stefano, Ceccanti

    1. The Application of Quality Risk Management to the Bacterial Endotoxins Test: Use of Hazard Analysis and Critical Control Points
      Carducci Annalaura, Davini Giulia and Ceccanti Stefano
      PDA Journal of Pharmaceutical Science and Technology September 2013, 67 (5) 553-567; DOI: https://doi.org/10.5731/pdajpst.2013.00938

  6. Stults, Cheryl L. M.

    1. Perspectives on the PQRI Extractables and Leachables “Safety Thresholds and Best Practices” Recommendations for Inhalation Drug Products
      Daniel L. Norwood, Lee M. Nagao and Cheryl L. M. Stults
      PDA Journal of Pharmaceutical Science and Technology September 2013, 67 (5) 413-429; DOI: https://doi.org/10.5731/pdajpst.2013.00934

Y

  1. Yang, Harry

    1. Setting Specifications of Correlated Quality Attributes through Multivariate Statistical Modelling
      Harry Yang
      PDA Journal of Pharmaceutical Science and Technology September 2013, 67 (5) 533-543; DOI: https://doi.org/10.5731/pdajpst.2013.00935
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