Table of Contents

January/February 2020; Volume 74,Issue 1

A

  1. Agalloco, James P.

    1. A Tale of Two Sterilizers
      James P. Agalloco
      PDA Journal of Pharmaceutical Science and Technology January 2020, 74 (1) 162-169; DOI: https://doi.org/10.5731/pdajpst.2019.009993

  2. Arribada, Raquel Gregorio

    1. Cleaning Validation for Residual Estimation of Mometasone Furoate on Stainless-Steel Surface of Pharmaceutical Manufacturing Equipment Using a UHPLC-UV Method
      Ana Silva Coelho, Raquel Gregorio Arribada and Eduardo Burgarelli Lages
      PDA Journal of Pharmaceutical Science and Technology January 2020, 74 (1) 41-48; DOI: https://doi.org/10.5731/pdajpst.2018.009712

B

  1. Baeten, Jan

    1. Identifying and Mitigating Errors in Screening for Organic Extractables and Leachables: Part 2—Errors of Inexact Identification and Inaccurate Quantitation
      Piet Christiaens, Jean-Marie Beusen, Philippe Verlinde, Jan Baeten and Dennis Jenke
      PDA Journal of Pharmaceutical Science and Technology January 2020, 74 (1) 108-133; DOI: https://doi.org/10.5731/pdajpst.2018.009779
    2. Identifying and Mitigating Errors in Screening for Organic Extractables and Leachables: Part 1—Introduction to Errors in Chromatographic Screening for Organic Extractables and Leachables and Discussion of the Errors of Omission
      Piet Christiaens, Jean-Marie Beusen, Philippe Verlinde, Jan Baeten and Dennis Jenke
      PDA Journal of Pharmaceutical Science and Technology January 2020, 74 (1) 90-107; DOI: https://doi.org/10.5731/pdajpst.2018.009761

  2. Beusen, Jean-Marie

    1. Identifying and Mitigating Errors in Screening for Organic Extractables and Leachables: Part 2—Errors of Inexact Identification and Inaccurate Quantitation
      Piet Christiaens, Jean-Marie Beusen, Philippe Verlinde, Jan Baeten and Dennis Jenke
      PDA Journal of Pharmaceutical Science and Technology January 2020, 74 (1) 108-133; DOI: https://doi.org/10.5731/pdajpst.2018.009779
    2. Identifying and Mitigating Errors in Screening for Organic Extractables and Leachables: Part 1—Introduction to Errors in Chromatographic Screening for Organic Extractables and Leachables and Discussion of the Errors of Omission
      Piet Christiaens, Jean-Marie Beusen, Philippe Verlinde, Jan Baeten and Dennis Jenke
      PDA Journal of Pharmaceutical Science and Technology January 2020, 74 (1) 90-107; DOI: https://doi.org/10.5731/pdajpst.2018.009761

  3. Bucci, Anthony

    1. Time Temperature Superposition Evaluation and Modeling for Container Closure System's Seal Performance at Low Temperatures
      Qingyu Zeng, Anthony Bucci and Le Ho
      PDA Journal of Pharmaceutical Science and Technology January 2020, 74 (1) 27-40; DOI: https://doi.org/10.5731/pdajpst.2019.010371

C

  1. Chern, Rey

    1. Impact of Excessive Sublimation Cooling on the Internal Temperature of Passive Shippers Cooled by Dry Ice
      Fanghua Mei, Pauline Yang, Chiawei Lai, Michael Ge and Rey Chern
      PDA Journal of Pharmaceutical Science and Technology January 2020, 74 (1) 49-57; DOI: https://doi.org/10.5731/pdajpst.2018.009589

  2. Christiaens, Piet

    1. Identifying and Mitigating Errors in Screening for Organic Extractables and Leachables: Part 2—Errors of Inexact Identification and Inaccurate Quantitation
      Piet Christiaens, Jean-Marie Beusen, Philippe Verlinde, Jan Baeten and Dennis Jenke
      PDA Journal of Pharmaceutical Science and Technology January 2020, 74 (1) 108-133; DOI: https://doi.org/10.5731/pdajpst.2018.009779
    2. Identifying and Mitigating Errors in Screening for Organic Extractables and Leachables: Part 1—Introduction to Errors in Chromatographic Screening for Organic Extractables and Leachables and Discussion of the Errors of Omission
      Piet Christiaens, Jean-Marie Beusen, Philippe Verlinde, Jan Baeten and Dennis Jenke
      PDA Journal of Pharmaceutical Science and Technology January 2020, 74 (1) 90-107; DOI: https://doi.org/10.5731/pdajpst.2018.009761

  3. Coelho, Ana Silva

    1. Cleaning Validation for Residual Estimation of Mometasone Furoate on Stainless-Steel Surface of Pharmaceutical Manufacturing Equipment Using a UHPLC-UV Method
      Ana Silva Coelho, Raquel Gregorio Arribada and Eduardo Burgarelli Lages
      PDA Journal of Pharmaceutical Science and Technology January 2020, 74 (1) 41-48; DOI: https://doi.org/10.5731/pdajpst.2018.009712

D

  1. Desai, Kashappa Goud

    1. Micro-Flow Imaging: Estimation of the Contribution of Key Factors to the Variability of Subvisible Particle Count Measurement by a Nested Statistical Analysis
      Kai Zhang, Thomas Wrzosek, Kashappa Goud Desai and Myrna Monck
      PDA Journal of Pharmaceutical Science and Technology January 2020, 74 (1) 15-26; DOI: https://doi.org/10.5731/pdajpst.2018.009324

  2. Downey, Dawn

    1. A Model of Prefilled Syringes Exposure to Vapor Phase Hydrogen Peroxide (VPHP)
      Dawn Downey, Bernard McGarvey, Michael Walsh and Jimmy Engle
      PDA Journal of Pharmaceutical Science and Technology January 2020, 74 (1) 73-89; DOI: https://doi.org/10.5731/pdajpst.2018.009431

E

  1. Engle, Jimmy

    1. A Model of Prefilled Syringes Exposure to Vapor Phase Hydrogen Peroxide (VPHP)
      Dawn Downey, Bernard McGarvey, Michael Walsh and Jimmy Engle
      PDA Journal of Pharmaceutical Science and Technology January 2020, 74 (1) 73-89; DOI: https://doi.org/10.5731/pdajpst.2018.009431

G

  1. Ge, Michael

    1. Impact of Excessive Sublimation Cooling on the Internal Temperature of Passive Shippers Cooled by Dry Ice
      Fanghua Mei, Pauline Yang, Chiawei Lai, Michael Ge and Rey Chern
      PDA Journal of Pharmaceutical Science and Technology January 2020, 74 (1) 49-57; DOI: https://doi.org/10.5731/pdajpst.2018.009589

  2. Gehrmann, Matthew R.

    1. Long-Term Study of Container Closure Integrity of Rubber–Glass Vial Systems by Multiple Methods
      Matthew R. Gehrmann and T. Page Mcandrew
      PDA Journal of Pharmaceutical Science and Technology January 2020, 74 (1) 147-161; DOI: https://doi.org/10.5731/pdajpst.2019.010223

  3. Greene, Anne

    1. Quality Risk Management—A Role-Based Competency Model
      Ghada Haddad and Anne Greene
      PDA Journal of Pharmaceutical Science and Technology January 2020, 74 (1) 58-72; DOI: https://doi.org/10.5731/pdajpst.2019.010496

H

  1. Haddad, Ghada

    1. Quality Risk Management—A Role-Based Competency Model
      Ghada Haddad and Anne Greene
      PDA Journal of Pharmaceutical Science and Technology January 2020, 74 (1) 58-72; DOI: https://doi.org/10.5731/pdajpst.2019.010496

  2. Ho, Le

    1. Time Temperature Superposition Evaluation and Modeling for Container Closure System's Seal Performance at Low Temperatures
      Qingyu Zeng, Anthony Bucci and Le Ho
      PDA Journal of Pharmaceutical Science and Technology January 2020, 74 (1) 27-40; DOI: https://doi.org/10.5731/pdajpst.2019.010371

J

  1. Jenke, Dennis

    1. Identifying and Mitigating Errors in Screening for Organic Extractables and Leachables: Part 2—Errors of Inexact Identification and Inaccurate Quantitation
      Piet Christiaens, Jean-Marie Beusen, Philippe Verlinde, Jan Baeten and Dennis Jenke
      PDA Journal of Pharmaceutical Science and Technology January 2020, 74 (1) 108-133; DOI: https://doi.org/10.5731/pdajpst.2018.009779
    2. Identifying and Mitigating Errors in Screening for Organic Extractables and Leachables: Part 1—Introduction to Errors in Chromatographic Screening for Organic Extractables and Leachables and Discussion of the Errors of Omission
      Piet Christiaens, Jean-Marie Beusen, Philippe Verlinde, Jan Baeten and Dennis Jenke
      PDA Journal of Pharmaceutical Science and Technology January 2020, 74 (1) 90-107; DOI: https://doi.org/10.5731/pdajpst.2018.009761
    3. Identifying and Mitigating Errors in Screening for Organic Extractables and Leachables: Part 3—Considering Errors of Implementation and the Use of a Database to Judge and Promote Good Science and Efficient Practices
      Dennis Jenke
      PDA Journal of Pharmaceutical Science and Technology January 2020, 74 (1) 134-146; DOI: https://doi.org/10.5731/pdajpst.2018.009787

K

  1. Kyad, Ali

    1. Development and Validation of a HPLC-UV Method for Urea and Related Impurities
      Getachew Woldemariam, Ali Kyad, Stephanie Moore, Jinshu Qiu, David Semin, Zhixin J. Tan and Jette Wypych
      PDA Journal of Pharmaceutical Science and Technology January 2020, 74 (1) 2-14; DOI: https://doi.org/10.5731/pdajpst.2018.009803

L

  1. Lages, Eduardo Burgarelli

    1. Cleaning Validation for Residual Estimation of Mometasone Furoate on Stainless-Steel Surface of Pharmaceutical Manufacturing Equipment Using a UHPLC-UV Method
      Ana Silva Coelho, Raquel Gregorio Arribada and Eduardo Burgarelli Lages
      PDA Journal of Pharmaceutical Science and Technology January 2020, 74 (1) 41-48; DOI: https://doi.org/10.5731/pdajpst.2018.009712

  2. Lai, Chiawei

    1. Impact of Excessive Sublimation Cooling on the Internal Temperature of Passive Shippers Cooled by Dry Ice
      Fanghua Mei, Pauline Yang, Chiawei Lai, Michael Ge and Rey Chern
      PDA Journal of Pharmaceutical Science and Technology January 2020, 74 (1) 49-57; DOI: https://doi.org/10.5731/pdajpst.2018.009589

  3. Levy, Richard

    1. Editor's Note
      Richard Levy
      PDA Journal of Pharmaceutical Science and Technology January 2020, 74 (1) 1; DOI: https://doi.org/10.5731/pdajpst.2019.001117

M

  1. Mcandrew, T. Page

    1. Long-Term Study of Container Closure Integrity of Rubber–Glass Vial Systems by Multiple Methods
      Matthew R. Gehrmann and T. Page Mcandrew
      PDA Journal of Pharmaceutical Science and Technology January 2020, 74 (1) 147-161; DOI: https://doi.org/10.5731/pdajpst.2019.010223

  2. McGarvey, Bernard

    1. A Model of Prefilled Syringes Exposure to Vapor Phase Hydrogen Peroxide (VPHP)
      Dawn Downey, Bernard McGarvey, Michael Walsh and Jimmy Engle
      PDA Journal of Pharmaceutical Science and Technology January 2020, 74 (1) 73-89; DOI: https://doi.org/10.5731/pdajpst.2018.009431

  3. Mei, Fanghua

    1. Impact of Excessive Sublimation Cooling on the Internal Temperature of Passive Shippers Cooled by Dry Ice
      Fanghua Mei, Pauline Yang, Chiawei Lai, Michael Ge and Rey Chern
      PDA Journal of Pharmaceutical Science and Technology January 2020, 74 (1) 49-57; DOI: https://doi.org/10.5731/pdajpst.2018.009589

  4. Monck, Myrna

    1. Micro-Flow Imaging: Estimation of the Contribution of Key Factors to the Variability of Subvisible Particle Count Measurement by a Nested Statistical Analysis
      Kai Zhang, Thomas Wrzosek, Kashappa Goud Desai and Myrna Monck
      PDA Journal of Pharmaceutical Science and Technology January 2020, 74 (1) 15-26; DOI: https://doi.org/10.5731/pdajpst.2018.009324

  5. Moore, Stephanie

    1. Development and Validation of a HPLC-UV Method for Urea and Related Impurities
      Getachew Woldemariam, Ali Kyad, Stephanie Moore, Jinshu Qiu, David Semin, Zhixin J. Tan and Jette Wypych
      PDA Journal of Pharmaceutical Science and Technology January 2020, 74 (1) 2-14; DOI: https://doi.org/10.5731/pdajpst.2018.009803

Q

  1. Qiu, Jinshu

    1. Development and Validation of a HPLC-UV Method for Urea and Related Impurities
      Getachew Woldemariam, Ali Kyad, Stephanie Moore, Jinshu Qiu, David Semin, Zhixin J. Tan and Jette Wypych
      PDA Journal of Pharmaceutical Science and Technology January 2020, 74 (1) 2-14; DOI: https://doi.org/10.5731/pdajpst.2018.009803

S

  1. Semin, David

    1. Development and Validation of a HPLC-UV Method for Urea and Related Impurities
      Getachew Woldemariam, Ali Kyad, Stephanie Moore, Jinshu Qiu, David Semin, Zhixin J. Tan and Jette Wypych
      PDA Journal of Pharmaceutical Science and Technology January 2020, 74 (1) 2-14; DOI: https://doi.org/10.5731/pdajpst.2018.009803

T

  1. Tan, Zhixin J.

    1. Development and Validation of a HPLC-UV Method for Urea and Related Impurities
      Getachew Woldemariam, Ali Kyad, Stephanie Moore, Jinshu Qiu, David Semin, Zhixin J. Tan and Jette Wypych
      PDA Journal of Pharmaceutical Science and Technology January 2020, 74 (1) 2-14; DOI: https://doi.org/10.5731/pdajpst.2018.009803

V

  1. Verlinde, Philippe

    1. Identifying and Mitigating Errors in Screening for Organic Extractables and Leachables: Part 2—Errors of Inexact Identification and Inaccurate Quantitation
      Piet Christiaens, Jean-Marie Beusen, Philippe Verlinde, Jan Baeten and Dennis Jenke
      PDA Journal of Pharmaceutical Science and Technology January 2020, 74 (1) 108-133; DOI: https://doi.org/10.5731/pdajpst.2018.009779
    2. Identifying and Mitigating Errors in Screening for Organic Extractables and Leachables: Part 1—Introduction to Errors in Chromatographic Screening for Organic Extractables and Leachables and Discussion of the Errors of Omission
      Piet Christiaens, Jean-Marie Beusen, Philippe Verlinde, Jan Baeten and Dennis Jenke
      PDA Journal of Pharmaceutical Science and Technology January 2020, 74 (1) 90-107; DOI: https://doi.org/10.5731/pdajpst.2018.009761

W

  1. Walsh, Michael

    1. A Model of Prefilled Syringes Exposure to Vapor Phase Hydrogen Peroxide (VPHP)
      Dawn Downey, Bernard McGarvey, Michael Walsh and Jimmy Engle
      PDA Journal of Pharmaceutical Science and Technology January 2020, 74 (1) 73-89; DOI: https://doi.org/10.5731/pdajpst.2018.009431

  2. Woldemariam, Getachew

    1. Development and Validation of a HPLC-UV Method for Urea and Related Impurities
      Getachew Woldemariam, Ali Kyad, Stephanie Moore, Jinshu Qiu, David Semin, Zhixin J. Tan and Jette Wypych
      PDA Journal of Pharmaceutical Science and Technology January 2020, 74 (1) 2-14; DOI: https://doi.org/10.5731/pdajpst.2018.009803

  3. Wrzosek, Thomas

    1. Micro-Flow Imaging: Estimation of the Contribution of Key Factors to the Variability of Subvisible Particle Count Measurement by a Nested Statistical Analysis
      Kai Zhang, Thomas Wrzosek, Kashappa Goud Desai and Myrna Monck
      PDA Journal of Pharmaceutical Science and Technology January 2020, 74 (1) 15-26; DOI: https://doi.org/10.5731/pdajpst.2018.009324

  4. Wypych, Jette

    1. Development and Validation of a HPLC-UV Method for Urea and Related Impurities
      Getachew Woldemariam, Ali Kyad, Stephanie Moore, Jinshu Qiu, David Semin, Zhixin J. Tan and Jette Wypych
      PDA Journal of Pharmaceutical Science and Technology January 2020, 74 (1) 2-14; DOI: https://doi.org/10.5731/pdajpst.2018.009803

Y

  1. Yang, Pauline

    1. Impact of Excessive Sublimation Cooling on the Internal Temperature of Passive Shippers Cooled by Dry Ice
      Fanghua Mei, Pauline Yang, Chiawei Lai, Michael Ge and Rey Chern
      PDA Journal of Pharmaceutical Science and Technology January 2020, 74 (1) 49-57; DOI: https://doi.org/10.5731/pdajpst.2018.009589

Z

  1. Zeng, Qingyu

    1. Time Temperature Superposition Evaluation and Modeling for Container Closure System's Seal Performance at Low Temperatures
      Qingyu Zeng, Anthony Bucci and Le Ho
      PDA Journal of Pharmaceutical Science and Technology January 2020, 74 (1) 27-40; DOI: https://doi.org/10.5731/pdajpst.2019.010371

  2. Zhang, Kai

    1. Micro-Flow Imaging: Estimation of the Contribution of Key Factors to the Variability of Subvisible Particle Count Measurement by a Nested Statistical Analysis
      Kai Zhang, Thomas Wrzosek, Kashappa Goud Desai and Myrna Monck
      PDA Journal of Pharmaceutical Science and Technology January 2020, 74 (1) 15-26; DOI: https://doi.org/10.5731/pdajpst.2018.009324
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