Table of Contents

January/February 2018; Volume 72,Issue 1

A

  1. Almeida, António J.

    1. A QRM Discussion of Microbial Contamination of Non-sterile Drug Products, Using FDA and EMA Warning Letters Recorded between 2008 and 2016
      Ana M. C. Santos, Mara S. Doria, Luís Meirinhos-Soares, António J. Almeida and José C. Menezes
      PDA Journal of Pharmaceutical Science and Technology January 2018, 72 (1) 62-72; DOI: https://doi.org/10.5731/pdajpst.2016.007252

  2. Arroyo, Adeyma

    1. Elastomer Change Out—Justification for Minimizing the Removal of Elastomers To Prevent Cross-Contamination in a Multiproduct Facility
      Michael Parks, Niamh O'Dwyer, Jeremy Bollinger, Alan Johnson, Brian Goss, Ned Wyman, Adeyma Arroyo, Joseph Wood and Derek Willison-Parry
      PDA Journal of Pharmaceutical Science and Technology January 2018, 72 (1) 81-90; DOI: https://doi.org/10.5731/pdajpst.2016.007484

B

  1. Barabani, David

    1. Guidelines for Risk-Based Changeover of Biopharma Multi-Product Facilities
      Rob Lynch, David Barabani, Kathy Bellorado, Peter Canisius, Doug Heathcote, Alan Johnson, Ned Wyman and Derek Willison Parry
      PDA Journal of Pharmaceutical Science and Technology January 2018, 72 (1) 91-103; DOI: https://doi.org/10.5731/pdajpst.2016.007419

  2. Bellorado, Kathy

    1. Guidelines for Risk-Based Changeover of Biopharma Multi-Product Facilities
      Rob Lynch, David Barabani, Kathy Bellorado, Peter Canisius, Doug Heathcote, Alan Johnson, Ned Wyman and Derek Willison Parry
      PDA Journal of Pharmaceutical Science and Technology January 2018, 72 (1) 91-103; DOI: https://doi.org/10.5731/pdajpst.2016.007419

  3. Berardo, Bruna Filipa Ribeiro

    1. Quality of Medicines in Portugal: A Retrospective Review of Medicine Recalls (2000–2015)
      Ana Teresa Machado Reis, Bruna Filipa Ribeiro Berardo and Rui Loureiro
      PDA Journal of Pharmaceutical Science and Technology January 2018, 72 (1) 44-49; DOI: https://doi.org/10.5731/pdajpst.2017.007567

  4. Bochis, Joy

    1. Real-Time PCR Detection of Burkholderia cepacia in Pharmaceutical Products Contaminated with Low Levels of Bacterial Contamination
      Luis Jimenez, Theranda Jashari, Jenifer Vasquez, Stephanie Zapata, Joy Bochis, Margarita Kulko, Victoria Ellman, Matthew Gardner and Tina Choe
      PDA Journal of Pharmaceutical Science and Technology January 2018, 72 (1) 73-80; DOI: https://doi.org/10.5731/pdajpst.2017.007971

  5. Bollinger, Jeremy

    1. Elastomer Change Out—Justification for Minimizing the Removal of Elastomers To Prevent Cross-Contamination in a Multiproduct Facility
      Michael Parks, Niamh O'Dwyer, Jeremy Bollinger, Alan Johnson, Brian Goss, Ned Wyman, Adeyma Arroyo, Joseph Wood and Derek Willison-Parry
      PDA Journal of Pharmaceutical Science and Technology January 2018, 72 (1) 81-90; DOI: https://doi.org/10.5731/pdajpst.2016.007484

  6. Breeland, Adam P.

    1. Inhibiting Sterilization-Induced Oxidation of Large Molecule Therapeutics Packaged in Plastic Parenteral Vials
      Jeffrey R. Vieregg, Steven J. Martin, Adam P. Breeland, Christopher M. Weikart and Matthew V. Tirrell
      PDA Journal of Pharmaceutical Science and Technology January 2018, 72 (1) 35-43; DOI: https://doi.org/10.5731/pdajpst.2017.008011

C

  1. Canisius, Peter

    1. Guidelines for Risk-Based Changeover of Biopharma Multi-Product Facilities
      Rob Lynch, David Barabani, Kathy Bellorado, Peter Canisius, Doug Heathcote, Alan Johnson, Ned Wyman and Derek Willison Parry
      PDA Journal of Pharmaceutical Science and Technology January 2018, 72 (1) 91-103; DOI: https://doi.org/10.5731/pdajpst.2016.007419

  2. Choe, Tina

    1. Real-Time PCR Detection of Burkholderia cepacia in Pharmaceutical Products Contaminated with Low Levels of Bacterial Contamination
      Luis Jimenez, Theranda Jashari, Jenifer Vasquez, Stephanie Zapata, Joy Bochis, Margarita Kulko, Victoria Ellman, Matthew Gardner and Tina Choe
      PDA Journal of Pharmaceutical Science and Technology January 2018, 72 (1) 73-80; DOI: https://doi.org/10.5731/pdajpst.2017.007971

D

  1. Degrazio, Fran L.

    1. Holistic Considerations in Optimizing a Sterile Product Package to Ensure Container Closure Integrity
      Fran L. Degrazio
      PDA Journal of Pharmaceutical Science and Technology January 2018, 72 (1) 15-34; DOI: https://doi.org/10.5731/pdajpst.2017.007658

  2. Dong, Xia

    1. Impact of Drug Formulation Variables on Silicone Oil Structure and Functionality of Prefilled Syringe System
      Galen H. Shi, Ganapathy Gopalrathnam, Sharon L. Shinkle, Xia Dong, Jeffrey D. Hofer, Eric C. Jensen and Natarajan Rajagopalan
      PDA Journal of Pharmaceutical Science and Technology January 2018, 72 (1) 50-61; DOI: https://doi.org/10.5731/pdajpst.2017.008169

  3. Doria, Mara S.

    1. A QRM Discussion of Microbial Contamination of Non-sterile Drug Products, Using FDA and EMA Warning Letters Recorded between 2008 and 2016
      Ana M. C. Santos, Mara S. Doria, Luís Meirinhos-Soares, António J. Almeida and José C. Menezes
      PDA Journal of Pharmaceutical Science and Technology January 2018, 72 (1) 62-72; DOI: https://doi.org/10.5731/pdajpst.2016.007252

E

  1. Ellman, Victoria

    1. Real-Time PCR Detection of Burkholderia cepacia in Pharmaceutical Products Contaminated with Low Levels of Bacterial Contamination
      Luis Jimenez, Theranda Jashari, Jenifer Vasquez, Stephanie Zapata, Joy Bochis, Margarita Kulko, Victoria Ellman, Matthew Gardner and Tina Choe
      PDA Journal of Pharmaceutical Science and Technology January 2018, 72 (1) 73-80; DOI: https://doi.org/10.5731/pdajpst.2017.007971

G

  1. Gardner, Matthew

    1. Real-Time PCR Detection of Burkholderia cepacia in Pharmaceutical Products Contaminated with Low Levels of Bacterial Contamination
      Luis Jimenez, Theranda Jashari, Jenifer Vasquez, Stephanie Zapata, Joy Bochis, Margarita Kulko, Victoria Ellman, Matthew Gardner and Tina Choe
      PDA Journal of Pharmaceutical Science and Technology January 2018, 72 (1) 73-80; DOI: https://doi.org/10.5731/pdajpst.2017.007971

  2. Gopalrathnam, Ganapathy

    1. Impact of Drug Formulation Variables on Silicone Oil Structure and Functionality of Prefilled Syringe System
      Galen H. Shi, Ganapathy Gopalrathnam, Sharon L. Shinkle, Xia Dong, Jeffrey D. Hofer, Eric C. Jensen and Natarajan Rajagopalan
      PDA Journal of Pharmaceutical Science and Technology January 2018, 72 (1) 50-61; DOI: https://doi.org/10.5731/pdajpst.2017.008169

  3. Goss, Brian

    1. Elastomer Change Out—Justification for Minimizing the Removal of Elastomers To Prevent Cross-Contamination in a Multiproduct Facility
      Michael Parks, Niamh O'Dwyer, Jeremy Bollinger, Alan Johnson, Brian Goss, Ned Wyman, Adeyma Arroyo, Joseph Wood and Derek Willison-Parry
      PDA Journal of Pharmaceutical Science and Technology January 2018, 72 (1) 81-90; DOI: https://doi.org/10.5731/pdajpst.2016.007484

H

  1. Heathcote, Doug

    1. Guidelines for Risk-Based Changeover of Biopharma Multi-Product Facilities
      Rob Lynch, David Barabani, Kathy Bellorado, Peter Canisius, Doug Heathcote, Alan Johnson, Ned Wyman and Derek Willison Parry
      PDA Journal of Pharmaceutical Science and Technology January 2018, 72 (1) 91-103; DOI: https://doi.org/10.5731/pdajpst.2016.007419

  2. Hofer, Jeffrey D.

    1. Impact of Drug Formulation Variables on Silicone Oil Structure and Functionality of Prefilled Syringe System
      Galen H. Shi, Ganapathy Gopalrathnam, Sharon L. Shinkle, Xia Dong, Jeffrey D. Hofer, Eric C. Jensen and Natarajan Rajagopalan
      PDA Journal of Pharmaceutical Science and Technology January 2018, 72 (1) 50-61; DOI: https://doi.org/10.5731/pdajpst.2017.008169

J

  1. Jashari, Theranda

    1. Real-Time PCR Detection of Burkholderia cepacia in Pharmaceutical Products Contaminated with Low Levels of Bacterial Contamination
      Luis Jimenez, Theranda Jashari, Jenifer Vasquez, Stephanie Zapata, Joy Bochis, Margarita Kulko, Victoria Ellman, Matthew Gardner and Tina Choe
      PDA Journal of Pharmaceutical Science and Technology January 2018, 72 (1) 73-80; DOI: https://doi.org/10.5731/pdajpst.2017.007971

  2. Jensen, Eric C.

    1. Impact of Drug Formulation Variables on Silicone Oil Structure and Functionality of Prefilled Syringe System
      Galen H. Shi, Ganapathy Gopalrathnam, Sharon L. Shinkle, Xia Dong, Jeffrey D. Hofer, Eric C. Jensen and Natarajan Rajagopalan
      PDA Journal of Pharmaceutical Science and Technology January 2018, 72 (1) 50-61; DOI: https://doi.org/10.5731/pdajpst.2017.008169

  3. Jimenez, Luis

    1. Real-Time PCR Detection of Burkholderia cepacia in Pharmaceutical Products Contaminated with Low Levels of Bacterial Contamination
      Luis Jimenez, Theranda Jashari, Jenifer Vasquez, Stephanie Zapata, Joy Bochis, Margarita Kulko, Victoria Ellman, Matthew Gardner and Tina Choe
      PDA Journal of Pharmaceutical Science and Technology January 2018, 72 (1) 73-80; DOI: https://doi.org/10.5731/pdajpst.2017.007971

  4. Johnson, Alan

    1. Guidelines for Risk-Based Changeover of Biopharma Multi-Product Facilities
      Rob Lynch, David Barabani, Kathy Bellorado, Peter Canisius, Doug Heathcote, Alan Johnson, Ned Wyman and Derek Willison Parry
      PDA Journal of Pharmaceutical Science and Technology January 2018, 72 (1) 91-103; DOI: https://doi.org/10.5731/pdajpst.2016.007419
    2. Elastomer Change Out—Justification for Minimizing the Removal of Elastomers To Prevent Cross-Contamination in a Multiproduct Facility
      Michael Parks, Niamh O'Dwyer, Jeremy Bollinger, Alan Johnson, Brian Goss, Ned Wyman, Adeyma Arroyo, Joseph Wood and Derek Willison-Parry
      PDA Journal of Pharmaceutical Science and Technology January 2018, 72 (1) 81-90; DOI: https://doi.org/10.5731/pdajpst.2016.007484

K

  1. Kulko, Margarita

    1. Real-Time PCR Detection of Burkholderia cepacia in Pharmaceutical Products Contaminated with Low Levels of Bacterial Contamination
      Luis Jimenez, Theranda Jashari, Jenifer Vasquez, Stephanie Zapata, Joy Bochis, Margarita Kulko, Victoria Ellman, Matthew Gardner and Tina Choe
      PDA Journal of Pharmaceutical Science and Technology January 2018, 72 (1) 73-80; DOI: https://doi.org/10.5731/pdajpst.2017.007971

L

  1. Loureiro, Rui

    1. Quality of Medicines in Portugal: A Retrospective Review of Medicine Recalls (2000–2015)
      Ana Teresa Machado Reis, Bruna Filipa Ribeiro Berardo and Rui Loureiro
      PDA Journal of Pharmaceutical Science and Technology January 2018, 72 (1) 44-49; DOI: https://doi.org/10.5731/pdajpst.2017.007567

  2. Lynch, Rob

    1. Guidelines for Risk-Based Changeover of Biopharma Multi-Product Facilities
      Rob Lynch, David Barabani, Kathy Bellorado, Peter Canisius, Doug Heathcote, Alan Johnson, Ned Wyman and Derek Willison Parry
      PDA Journal of Pharmaceutical Science and Technology January 2018, 72 (1) 91-103; DOI: https://doi.org/10.5731/pdajpst.2016.007419

M

  1. Machado Reis, Ana Teresa

    1. Quality of Medicines in Portugal: A Retrospective Review of Medicine Recalls (2000–2015)
      Ana Teresa Machado Reis, Bruna Filipa Ribeiro Berardo and Rui Loureiro
      PDA Journal of Pharmaceutical Science and Technology January 2018, 72 (1) 44-49; DOI: https://doi.org/10.5731/pdajpst.2017.007567

  2. Martin, Steven J.

    1. Inhibiting Sterilization-Induced Oxidation of Large Molecule Therapeutics Packaged in Plastic Parenteral Vials
      Jeffrey R. Vieregg, Steven J. Martin, Adam P. Breeland, Christopher M. Weikart and Matthew V. Tirrell
      PDA Journal of Pharmaceutical Science and Technology January 2018, 72 (1) 35-43; DOI: https://doi.org/10.5731/pdajpst.2017.008011

  3. Meirinhos-Soares, Luís

    1. A QRM Discussion of Microbial Contamination of Non-sterile Drug Products, Using FDA and EMA Warning Letters Recorded between 2008 and 2016
      Ana M. C. Santos, Mara S. Doria, Luís Meirinhos-Soares, António J. Almeida and José C. Menezes
      PDA Journal of Pharmaceutical Science and Technology January 2018, 72 (1) 62-72; DOI: https://doi.org/10.5731/pdajpst.2016.007252

  4. Menezes, José C.

    1. A QRM Discussion of Microbial Contamination of Non-sterile Drug Products, Using FDA and EMA Warning Letters Recorded between 2008 and 2016
      Ana M. C. Santos, Mara S. Doria, Luís Meirinhos-Soares, António J. Almeida and José C. Menezes
      PDA Journal of Pharmaceutical Science and Technology January 2018, 72 (1) 62-72; DOI: https://doi.org/10.5731/pdajpst.2016.007252

O

  1. O'Dwyer, Niamh

    1. Elastomer Change Out—Justification for Minimizing the Removal of Elastomers To Prevent Cross-Contamination in a Multiproduct Facility
      Michael Parks, Niamh O'Dwyer, Jeremy Bollinger, Alan Johnson, Brian Goss, Ned Wyman, Adeyma Arroyo, Joseph Wood and Derek Willison-Parry
      PDA Journal of Pharmaceutical Science and Technology January 2018, 72 (1) 81-90; DOI: https://doi.org/10.5731/pdajpst.2016.007484

P

  1. Parks, Michael

    1. Elastomer Change Out—Justification for Minimizing the Removal of Elastomers To Prevent Cross-Contamination in a Multiproduct Facility
      Michael Parks, Niamh O'Dwyer, Jeremy Bollinger, Alan Johnson, Brian Goss, Ned Wyman, Adeyma Arroyo, Joseph Wood and Derek Willison-Parry
      PDA Journal of Pharmaceutical Science and Technology January 2018, 72 (1) 81-90; DOI: https://doi.org/10.5731/pdajpst.2016.007484

  2. Parry, Derek Willison

    1. Guidelines for Risk-Based Changeover of Biopharma Multi-Product Facilities
      Rob Lynch, David Barabani, Kathy Bellorado, Peter Canisius, Doug Heathcote, Alan Johnson, Ned Wyman and Derek Willison Parry
      PDA Journal of Pharmaceutical Science and Technology January 2018, 72 (1) 91-103; DOI: https://doi.org/10.5731/pdajpst.2016.007419

R

  1. Rajagopalan, Natarajan

    1. Impact of Drug Formulation Variables on Silicone Oil Structure and Functionality of Prefilled Syringe System
      Galen H. Shi, Ganapathy Gopalrathnam, Sharon L. Shinkle, Xia Dong, Jeffrey D. Hofer, Eric C. Jensen and Natarajan Rajagopalan
      PDA Journal of Pharmaceutical Science and Technology January 2018, 72 (1) 50-61; DOI: https://doi.org/10.5731/pdajpst.2017.008169

  2. Rathore, Anurag S.

    1. Approval of Ogivri
      Anurag S. Rathore
      PDA Journal of Pharmaceutical Science and Technology January 2018, 72 (1) 1; DOI: https://doi.org/10.5731/pdajpst.2018.001105

S

  1. Sandle, Tim

    1. Microbiological Test Data—Assuring Data Integrity
      Edward C. Tidswell and Tim Sandle
      PDA Journal of Pharmaceutical Science and Technology January 2018, 72 (1) 2-14; DOI: https://doi.org/10.5731/pdajpst.2017.008151

  2. Santos, Ana M. C.

    1. A QRM Discussion of Microbial Contamination of Non-sterile Drug Products, Using FDA and EMA Warning Letters Recorded between 2008 and 2016
      Ana M. C. Santos, Mara S. Doria, Luís Meirinhos-Soares, António J. Almeida and José C. Menezes
      PDA Journal of Pharmaceutical Science and Technology January 2018, 72 (1) 62-72; DOI: https://doi.org/10.5731/pdajpst.2016.007252

  3. Shi, Galen H.

    1. Impact of Drug Formulation Variables on Silicone Oil Structure and Functionality of Prefilled Syringe System
      Galen H. Shi, Ganapathy Gopalrathnam, Sharon L. Shinkle, Xia Dong, Jeffrey D. Hofer, Eric C. Jensen and Natarajan Rajagopalan
      PDA Journal of Pharmaceutical Science and Technology January 2018, 72 (1) 50-61; DOI: https://doi.org/10.5731/pdajpst.2017.008169

  4. Shinkle, Sharon L.

    1. Impact of Drug Formulation Variables on Silicone Oil Structure and Functionality of Prefilled Syringe System
      Galen H. Shi, Ganapathy Gopalrathnam, Sharon L. Shinkle, Xia Dong, Jeffrey D. Hofer, Eric C. Jensen and Natarajan Rajagopalan
      PDA Journal of Pharmaceutical Science and Technology January 2018, 72 (1) 50-61; DOI: https://doi.org/10.5731/pdajpst.2017.008169

T

  1. Tidswell, Edward C.

    1. Microbiological Test Data—Assuring Data Integrity
      Edward C. Tidswell and Tim Sandle
      PDA Journal of Pharmaceutical Science and Technology January 2018, 72 (1) 2-14; DOI: https://doi.org/10.5731/pdajpst.2017.008151

  2. Tirrell, Matthew V.

    1. Inhibiting Sterilization-Induced Oxidation of Large Molecule Therapeutics Packaged in Plastic Parenteral Vials
      Jeffrey R. Vieregg, Steven J. Martin, Adam P. Breeland, Christopher M. Weikart and Matthew V. Tirrell
      PDA Journal of Pharmaceutical Science and Technology January 2018, 72 (1) 35-43; DOI: https://doi.org/10.5731/pdajpst.2017.008011

V

  1. Vasquez, Jenifer

    1. Real-Time PCR Detection of Burkholderia cepacia in Pharmaceutical Products Contaminated with Low Levels of Bacterial Contamination
      Luis Jimenez, Theranda Jashari, Jenifer Vasquez, Stephanie Zapata, Joy Bochis, Margarita Kulko, Victoria Ellman, Matthew Gardner and Tina Choe
      PDA Journal of Pharmaceutical Science and Technology January 2018, 72 (1) 73-80; DOI: https://doi.org/10.5731/pdajpst.2017.007971

  2. Vieregg, Jeffrey R.

    1. Inhibiting Sterilization-Induced Oxidation of Large Molecule Therapeutics Packaged in Plastic Parenteral Vials
      Jeffrey R. Vieregg, Steven J. Martin, Adam P. Breeland, Christopher M. Weikart and Matthew V. Tirrell
      PDA Journal of Pharmaceutical Science and Technology January 2018, 72 (1) 35-43; DOI: https://doi.org/10.5731/pdajpst.2017.008011

W

  1. Weikart, Christopher M.

    1. Inhibiting Sterilization-Induced Oxidation of Large Molecule Therapeutics Packaged in Plastic Parenteral Vials
      Jeffrey R. Vieregg, Steven J. Martin, Adam P. Breeland, Christopher M. Weikart and Matthew V. Tirrell
      PDA Journal of Pharmaceutical Science and Technology January 2018, 72 (1) 35-43; DOI: https://doi.org/10.5731/pdajpst.2017.008011

  2. Willison-Parry, Derek

    1. Elastomer Change Out—Justification for Minimizing the Removal of Elastomers To Prevent Cross-Contamination in a Multiproduct Facility
      Michael Parks, Niamh O'Dwyer, Jeremy Bollinger, Alan Johnson, Brian Goss, Ned Wyman, Adeyma Arroyo, Joseph Wood and Derek Willison-Parry
      PDA Journal of Pharmaceutical Science and Technology January 2018, 72 (1) 81-90; DOI: https://doi.org/10.5731/pdajpst.2016.007484

  3. Wood, Joseph

    1. Elastomer Change Out—Justification for Minimizing the Removal of Elastomers To Prevent Cross-Contamination in a Multiproduct Facility
      Michael Parks, Niamh O'Dwyer, Jeremy Bollinger, Alan Johnson, Brian Goss, Ned Wyman, Adeyma Arroyo, Joseph Wood and Derek Willison-Parry
      PDA Journal of Pharmaceutical Science and Technology January 2018, 72 (1) 81-90; DOI: https://doi.org/10.5731/pdajpst.2016.007484

  4. Wyman, Ned

    1. Guidelines for Risk-Based Changeover of Biopharma Multi-Product Facilities
      Rob Lynch, David Barabani, Kathy Bellorado, Peter Canisius, Doug Heathcote, Alan Johnson, Ned Wyman and Derek Willison Parry
      PDA Journal of Pharmaceutical Science and Technology January 2018, 72 (1) 91-103; DOI: https://doi.org/10.5731/pdajpst.2016.007419
    2. Elastomer Change Out—Justification for Minimizing the Removal of Elastomers To Prevent Cross-Contamination in a Multiproduct Facility
      Michael Parks, Niamh O'Dwyer, Jeremy Bollinger, Alan Johnson, Brian Goss, Ned Wyman, Adeyma Arroyo, Joseph Wood and Derek Willison-Parry
      PDA Journal of Pharmaceutical Science and Technology January 2018, 72 (1) 81-90; DOI: https://doi.org/10.5731/pdajpst.2016.007484

Z

  1. Zapata, Stephanie

    1. Real-Time PCR Detection of Burkholderia cepacia in Pharmaceutical Products Contaminated with Low Levels of Bacterial Contamination
      Luis Jimenez, Theranda Jashari, Jenifer Vasquez, Stephanie Zapata, Joy Bochis, Margarita Kulko, Victoria Ellman, Matthew Gardner and Tina Choe
      PDA Journal of Pharmaceutical Science and Technology January 2018, 72 (1) 73-80; DOI: https://doi.org/10.5731/pdajpst.2017.007971
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