Table of Contents
January/February 2018; Volume 72,Issue 1
A
Almeida, António J.
- You have accessA QRM Discussion of Microbial Contamination of Non-sterile Drug Products, Using FDA and EMA Warning Letters Recorded between 2008 and 2016Ana M. C. Santos, Mara S. Doria, Luís Meirinhos-Soares, António J. Almeida and José C. MenezesPDA Journal of Pharmaceutical Science and Technology January 2018, 72 (1) 62-72; DOI: https://doi.org/10.5731/pdajpst.2016.007252
Arroyo, Adeyma
- You have accessElastomer Change Out—Justification for Minimizing the Removal of Elastomers To Prevent Cross-Contamination in a Multiproduct FacilityMichael Parks, Niamh O'Dwyer, Jeremy Bollinger, Alan Johnson, Brian Goss, Ned Wyman, Adeyma Arroyo, Joseph Wood and Derek Willison-ParryPDA Journal of Pharmaceutical Science and Technology January 2018, 72 (1) 81-90; DOI: https://doi.org/10.5731/pdajpst.2016.007484
B
Barabani, David
- You have accessGuidelines for Risk-Based Changeover of Biopharma Multi-Product FacilitiesRob Lynch, David Barabani, Kathy Bellorado, Peter Canisius, Doug Heathcote, Alan Johnson, Ned Wyman and Derek Willison ParryPDA Journal of Pharmaceutical Science and Technology January 2018, 72 (1) 91-103; DOI: https://doi.org/10.5731/pdajpst.2016.007419
Bellorado, Kathy
- You have accessGuidelines for Risk-Based Changeover of Biopharma Multi-Product FacilitiesRob Lynch, David Barabani, Kathy Bellorado, Peter Canisius, Doug Heathcote, Alan Johnson, Ned Wyman and Derek Willison ParryPDA Journal of Pharmaceutical Science and Technology January 2018, 72 (1) 91-103; DOI: https://doi.org/10.5731/pdajpst.2016.007419
Berardo, Bruna Filipa Ribeiro
- You have accessQuality of Medicines in Portugal: A Retrospective Review of Medicine Recalls (2000–2015)Ana Teresa Machado Reis, Bruna Filipa Ribeiro Berardo and Rui LoureiroPDA Journal of Pharmaceutical Science and Technology January 2018, 72 (1) 44-49; DOI: https://doi.org/10.5731/pdajpst.2017.007567
Bochis, Joy
- You have accessReal-Time PCR Detection of Burkholderia cepacia in Pharmaceutical Products Contaminated with Low Levels of Bacterial ContaminationLuis Jimenez, Theranda Jashari, Jenifer Vasquez, Stephanie Zapata, Joy Bochis, Margarita Kulko, Victoria Ellman, Matthew Gardner and Tina ChoePDA Journal of Pharmaceutical Science and Technology January 2018, 72 (1) 73-80; DOI: https://doi.org/10.5731/pdajpst.2017.007971
Bollinger, Jeremy
- You have accessElastomer Change Out—Justification for Minimizing the Removal of Elastomers To Prevent Cross-Contamination in a Multiproduct FacilityMichael Parks, Niamh O'Dwyer, Jeremy Bollinger, Alan Johnson, Brian Goss, Ned Wyman, Adeyma Arroyo, Joseph Wood and Derek Willison-ParryPDA Journal of Pharmaceutical Science and Technology January 2018, 72 (1) 81-90; DOI: https://doi.org/10.5731/pdajpst.2016.007484
Breeland, Adam P.
- You have accessInhibiting Sterilization-Induced Oxidation of Large Molecule Therapeutics Packaged in Plastic Parenteral VialsJeffrey R. Vieregg, Steven J. Martin, Adam P. Breeland, Christopher M. Weikart and Matthew V. TirrellPDA Journal of Pharmaceutical Science and Technology January 2018, 72 (1) 35-43; DOI: https://doi.org/10.5731/pdajpst.2017.008011
C
Canisius, Peter
- You have accessGuidelines for Risk-Based Changeover of Biopharma Multi-Product FacilitiesRob Lynch, David Barabani, Kathy Bellorado, Peter Canisius, Doug Heathcote, Alan Johnson, Ned Wyman and Derek Willison ParryPDA Journal of Pharmaceutical Science and Technology January 2018, 72 (1) 91-103; DOI: https://doi.org/10.5731/pdajpst.2016.007419
Choe, Tina
- You have accessReal-Time PCR Detection of Burkholderia cepacia in Pharmaceutical Products Contaminated with Low Levels of Bacterial ContaminationLuis Jimenez, Theranda Jashari, Jenifer Vasquez, Stephanie Zapata, Joy Bochis, Margarita Kulko, Victoria Ellman, Matthew Gardner and Tina ChoePDA Journal of Pharmaceutical Science and Technology January 2018, 72 (1) 73-80; DOI: https://doi.org/10.5731/pdajpst.2017.007971
D
Degrazio, Fran L.
- You have accessHolistic Considerations in Optimizing a Sterile Product Package to Ensure Container Closure IntegrityFran L. DegrazioPDA Journal of Pharmaceutical Science and Technology January 2018, 72 (1) 15-34; DOI: https://doi.org/10.5731/pdajpst.2017.007658
Dong, Xia
- You have accessImpact of Drug Formulation Variables on Silicone Oil Structure and Functionality of Prefilled Syringe SystemGalen H. Shi, Ganapathy Gopalrathnam, Sharon L. Shinkle, Xia Dong, Jeffrey D. Hofer, Eric C. Jensen and Natarajan RajagopalanPDA Journal of Pharmaceutical Science and Technology January 2018, 72 (1) 50-61; DOI: https://doi.org/10.5731/pdajpst.2017.008169
Doria, Mara S.
- You have accessA QRM Discussion of Microbial Contamination of Non-sterile Drug Products, Using FDA and EMA Warning Letters Recorded between 2008 and 2016Ana M. C. Santos, Mara S. Doria, Luís Meirinhos-Soares, António J. Almeida and José C. MenezesPDA Journal of Pharmaceutical Science and Technology January 2018, 72 (1) 62-72; DOI: https://doi.org/10.5731/pdajpst.2016.007252
E
Ellman, Victoria
- You have accessReal-Time PCR Detection of Burkholderia cepacia in Pharmaceutical Products Contaminated with Low Levels of Bacterial ContaminationLuis Jimenez, Theranda Jashari, Jenifer Vasquez, Stephanie Zapata, Joy Bochis, Margarita Kulko, Victoria Ellman, Matthew Gardner and Tina ChoePDA Journal of Pharmaceutical Science and Technology January 2018, 72 (1) 73-80; DOI: https://doi.org/10.5731/pdajpst.2017.007971
G
Gardner, Matthew
- You have accessReal-Time PCR Detection of Burkholderia cepacia in Pharmaceutical Products Contaminated with Low Levels of Bacterial ContaminationLuis Jimenez, Theranda Jashari, Jenifer Vasquez, Stephanie Zapata, Joy Bochis, Margarita Kulko, Victoria Ellman, Matthew Gardner and Tina ChoePDA Journal of Pharmaceutical Science and Technology January 2018, 72 (1) 73-80; DOI: https://doi.org/10.5731/pdajpst.2017.007971
Gopalrathnam, Ganapathy
- You have accessImpact of Drug Formulation Variables on Silicone Oil Structure and Functionality of Prefilled Syringe SystemGalen H. Shi, Ganapathy Gopalrathnam, Sharon L. Shinkle, Xia Dong, Jeffrey D. Hofer, Eric C. Jensen and Natarajan RajagopalanPDA Journal of Pharmaceutical Science and Technology January 2018, 72 (1) 50-61; DOI: https://doi.org/10.5731/pdajpst.2017.008169
Goss, Brian
- You have accessElastomer Change Out—Justification for Minimizing the Removal of Elastomers To Prevent Cross-Contamination in a Multiproduct FacilityMichael Parks, Niamh O'Dwyer, Jeremy Bollinger, Alan Johnson, Brian Goss, Ned Wyman, Adeyma Arroyo, Joseph Wood and Derek Willison-ParryPDA Journal of Pharmaceutical Science and Technology January 2018, 72 (1) 81-90; DOI: https://doi.org/10.5731/pdajpst.2016.007484
H
Heathcote, Doug
- You have accessGuidelines for Risk-Based Changeover of Biopharma Multi-Product FacilitiesRob Lynch, David Barabani, Kathy Bellorado, Peter Canisius, Doug Heathcote, Alan Johnson, Ned Wyman and Derek Willison ParryPDA Journal of Pharmaceutical Science and Technology January 2018, 72 (1) 91-103; DOI: https://doi.org/10.5731/pdajpst.2016.007419
Hofer, Jeffrey D.
- You have accessImpact of Drug Formulation Variables on Silicone Oil Structure and Functionality of Prefilled Syringe SystemGalen H. Shi, Ganapathy Gopalrathnam, Sharon L. Shinkle, Xia Dong, Jeffrey D. Hofer, Eric C. Jensen and Natarajan RajagopalanPDA Journal of Pharmaceutical Science and Technology January 2018, 72 (1) 50-61; DOI: https://doi.org/10.5731/pdajpst.2017.008169
J
Jashari, Theranda
- You have accessReal-Time PCR Detection of Burkholderia cepacia in Pharmaceutical Products Contaminated with Low Levels of Bacterial ContaminationLuis Jimenez, Theranda Jashari, Jenifer Vasquez, Stephanie Zapata, Joy Bochis, Margarita Kulko, Victoria Ellman, Matthew Gardner and Tina ChoePDA Journal of Pharmaceutical Science and Technology January 2018, 72 (1) 73-80; DOI: https://doi.org/10.5731/pdajpst.2017.007971
Jensen, Eric C.
- You have accessImpact of Drug Formulation Variables on Silicone Oil Structure and Functionality of Prefilled Syringe SystemGalen H. Shi, Ganapathy Gopalrathnam, Sharon L. Shinkle, Xia Dong, Jeffrey D. Hofer, Eric C. Jensen and Natarajan RajagopalanPDA Journal of Pharmaceutical Science and Technology January 2018, 72 (1) 50-61; DOI: https://doi.org/10.5731/pdajpst.2017.008169
Jimenez, Luis
- You have accessReal-Time PCR Detection of Burkholderia cepacia in Pharmaceutical Products Contaminated with Low Levels of Bacterial ContaminationLuis Jimenez, Theranda Jashari, Jenifer Vasquez, Stephanie Zapata, Joy Bochis, Margarita Kulko, Victoria Ellman, Matthew Gardner and Tina ChoePDA Journal of Pharmaceutical Science and Technology January 2018, 72 (1) 73-80; DOI: https://doi.org/10.5731/pdajpst.2017.007971
Johnson, Alan
- You have accessGuidelines for Risk-Based Changeover of Biopharma Multi-Product FacilitiesRob Lynch, David Barabani, Kathy Bellorado, Peter Canisius, Doug Heathcote, Alan Johnson, Ned Wyman and Derek Willison ParryPDA Journal of Pharmaceutical Science and Technology January 2018, 72 (1) 91-103; DOI: https://doi.org/10.5731/pdajpst.2016.007419
- You have accessElastomer Change Out—Justification for Minimizing the Removal of Elastomers To Prevent Cross-Contamination in a Multiproduct FacilityMichael Parks, Niamh O'Dwyer, Jeremy Bollinger, Alan Johnson, Brian Goss, Ned Wyman, Adeyma Arroyo, Joseph Wood and Derek Willison-ParryPDA Journal of Pharmaceutical Science and Technology January 2018, 72 (1) 81-90; DOI: https://doi.org/10.5731/pdajpst.2016.007484
K
Kulko, Margarita
- You have accessReal-Time PCR Detection of Burkholderia cepacia in Pharmaceutical Products Contaminated with Low Levels of Bacterial ContaminationLuis Jimenez, Theranda Jashari, Jenifer Vasquez, Stephanie Zapata, Joy Bochis, Margarita Kulko, Victoria Ellman, Matthew Gardner and Tina ChoePDA Journal of Pharmaceutical Science and Technology January 2018, 72 (1) 73-80; DOI: https://doi.org/10.5731/pdajpst.2017.007971
L
Loureiro, Rui
- You have accessQuality of Medicines in Portugal: A Retrospective Review of Medicine Recalls (2000–2015)Ana Teresa Machado Reis, Bruna Filipa Ribeiro Berardo and Rui LoureiroPDA Journal of Pharmaceutical Science and Technology January 2018, 72 (1) 44-49; DOI: https://doi.org/10.5731/pdajpst.2017.007567
Lynch, Rob
- You have accessGuidelines for Risk-Based Changeover of Biopharma Multi-Product FacilitiesRob Lynch, David Barabani, Kathy Bellorado, Peter Canisius, Doug Heathcote, Alan Johnson, Ned Wyman and Derek Willison ParryPDA Journal of Pharmaceutical Science and Technology January 2018, 72 (1) 91-103; DOI: https://doi.org/10.5731/pdajpst.2016.007419
M
Machado Reis, Ana Teresa
- You have accessQuality of Medicines in Portugal: A Retrospective Review of Medicine Recalls (2000–2015)Ana Teresa Machado Reis, Bruna Filipa Ribeiro Berardo and Rui LoureiroPDA Journal of Pharmaceutical Science and Technology January 2018, 72 (1) 44-49; DOI: https://doi.org/10.5731/pdajpst.2017.007567
Martin, Steven J.
- You have accessInhibiting Sterilization-Induced Oxidation of Large Molecule Therapeutics Packaged in Plastic Parenteral VialsJeffrey R. Vieregg, Steven J. Martin, Adam P. Breeland, Christopher M. Weikart and Matthew V. TirrellPDA Journal of Pharmaceutical Science and Technology January 2018, 72 (1) 35-43; DOI: https://doi.org/10.5731/pdajpst.2017.008011
Meirinhos-Soares, Luís
- You have accessA QRM Discussion of Microbial Contamination of Non-sterile Drug Products, Using FDA and EMA Warning Letters Recorded between 2008 and 2016Ana M. C. Santos, Mara S. Doria, Luís Meirinhos-Soares, António J. Almeida and José C. MenezesPDA Journal of Pharmaceutical Science and Technology January 2018, 72 (1) 62-72; DOI: https://doi.org/10.5731/pdajpst.2016.007252
Menezes, José C.
- You have accessA QRM Discussion of Microbial Contamination of Non-sterile Drug Products, Using FDA and EMA Warning Letters Recorded between 2008 and 2016Ana M. C. Santos, Mara S. Doria, Luís Meirinhos-Soares, António J. Almeida and José C. MenezesPDA Journal of Pharmaceutical Science and Technology January 2018, 72 (1) 62-72; DOI: https://doi.org/10.5731/pdajpst.2016.007252
O
O'Dwyer, Niamh
- You have accessElastomer Change Out—Justification for Minimizing the Removal of Elastomers To Prevent Cross-Contamination in a Multiproduct FacilityMichael Parks, Niamh O'Dwyer, Jeremy Bollinger, Alan Johnson, Brian Goss, Ned Wyman, Adeyma Arroyo, Joseph Wood and Derek Willison-ParryPDA Journal of Pharmaceutical Science and Technology January 2018, 72 (1) 81-90; DOI: https://doi.org/10.5731/pdajpst.2016.007484
P
Parks, Michael
- You have accessElastomer Change Out—Justification for Minimizing the Removal of Elastomers To Prevent Cross-Contamination in a Multiproduct FacilityMichael Parks, Niamh O'Dwyer, Jeremy Bollinger, Alan Johnson, Brian Goss, Ned Wyman, Adeyma Arroyo, Joseph Wood and Derek Willison-ParryPDA Journal of Pharmaceutical Science and Technology January 2018, 72 (1) 81-90; DOI: https://doi.org/10.5731/pdajpst.2016.007484
Parry, Derek Willison
- You have accessGuidelines for Risk-Based Changeover of Biopharma Multi-Product FacilitiesRob Lynch, David Barabani, Kathy Bellorado, Peter Canisius, Doug Heathcote, Alan Johnson, Ned Wyman and Derek Willison ParryPDA Journal of Pharmaceutical Science and Technology January 2018, 72 (1) 91-103; DOI: https://doi.org/10.5731/pdajpst.2016.007419
R
Rajagopalan, Natarajan
- You have accessImpact of Drug Formulation Variables on Silicone Oil Structure and Functionality of Prefilled Syringe SystemGalen H. Shi, Ganapathy Gopalrathnam, Sharon L. Shinkle, Xia Dong, Jeffrey D. Hofer, Eric C. Jensen and Natarajan RajagopalanPDA Journal of Pharmaceutical Science and Technology January 2018, 72 (1) 50-61; DOI: https://doi.org/10.5731/pdajpst.2017.008169
Rathore, Anurag S.
- You have accessApproval of OgivriAnurag S. RathorePDA Journal of Pharmaceutical Science and Technology January 2018, 72 (1) 1; DOI: https://doi.org/10.5731/pdajpst.2018.001105
S
Sandle, Tim
- You have accessMicrobiological Test Data—Assuring Data IntegrityEdward C. Tidswell and Tim SandlePDA Journal of Pharmaceutical Science and Technology January 2018, 72 (1) 2-14; DOI: https://doi.org/10.5731/pdajpst.2017.008151
Santos, Ana M. C.
- You have accessA QRM Discussion of Microbial Contamination of Non-sterile Drug Products, Using FDA and EMA Warning Letters Recorded between 2008 and 2016Ana M. C. Santos, Mara S. Doria, Luís Meirinhos-Soares, António J. Almeida and José C. MenezesPDA Journal of Pharmaceutical Science and Technology January 2018, 72 (1) 62-72; DOI: https://doi.org/10.5731/pdajpst.2016.007252
Shi, Galen H.
- You have accessImpact of Drug Formulation Variables on Silicone Oil Structure and Functionality of Prefilled Syringe SystemGalen H. Shi, Ganapathy Gopalrathnam, Sharon L. Shinkle, Xia Dong, Jeffrey D. Hofer, Eric C. Jensen and Natarajan RajagopalanPDA Journal of Pharmaceutical Science and Technology January 2018, 72 (1) 50-61; DOI: https://doi.org/10.5731/pdajpst.2017.008169
Shinkle, Sharon L.
- You have accessImpact of Drug Formulation Variables on Silicone Oil Structure and Functionality of Prefilled Syringe SystemGalen H. Shi, Ganapathy Gopalrathnam, Sharon L. Shinkle, Xia Dong, Jeffrey D. Hofer, Eric C. Jensen and Natarajan RajagopalanPDA Journal of Pharmaceutical Science and Technology January 2018, 72 (1) 50-61; DOI: https://doi.org/10.5731/pdajpst.2017.008169
T
Tidswell, Edward C.
- You have accessMicrobiological Test Data—Assuring Data IntegrityEdward C. Tidswell and Tim SandlePDA Journal of Pharmaceutical Science and Technology January 2018, 72 (1) 2-14; DOI: https://doi.org/10.5731/pdajpst.2017.008151
Tirrell, Matthew V.
- You have accessInhibiting Sterilization-Induced Oxidation of Large Molecule Therapeutics Packaged in Plastic Parenteral VialsJeffrey R. Vieregg, Steven J. Martin, Adam P. Breeland, Christopher M. Weikart and Matthew V. TirrellPDA Journal of Pharmaceutical Science and Technology January 2018, 72 (1) 35-43; DOI: https://doi.org/10.5731/pdajpst.2017.008011
V
Vasquez, Jenifer
- You have accessReal-Time PCR Detection of Burkholderia cepacia in Pharmaceutical Products Contaminated with Low Levels of Bacterial ContaminationLuis Jimenez, Theranda Jashari, Jenifer Vasquez, Stephanie Zapata, Joy Bochis, Margarita Kulko, Victoria Ellman, Matthew Gardner and Tina ChoePDA Journal of Pharmaceutical Science and Technology January 2018, 72 (1) 73-80; DOI: https://doi.org/10.5731/pdajpst.2017.007971
Vieregg, Jeffrey R.
- You have accessInhibiting Sterilization-Induced Oxidation of Large Molecule Therapeutics Packaged in Plastic Parenteral VialsJeffrey R. Vieregg, Steven J. Martin, Adam P. Breeland, Christopher M. Weikart and Matthew V. TirrellPDA Journal of Pharmaceutical Science and Technology January 2018, 72 (1) 35-43; DOI: https://doi.org/10.5731/pdajpst.2017.008011
W
Weikart, Christopher M.
- You have accessInhibiting Sterilization-Induced Oxidation of Large Molecule Therapeutics Packaged in Plastic Parenteral VialsJeffrey R. Vieregg, Steven J. Martin, Adam P. Breeland, Christopher M. Weikart and Matthew V. TirrellPDA Journal of Pharmaceutical Science and Technology January 2018, 72 (1) 35-43; DOI: https://doi.org/10.5731/pdajpst.2017.008011
Willison-Parry, Derek
- You have accessElastomer Change Out—Justification for Minimizing the Removal of Elastomers To Prevent Cross-Contamination in a Multiproduct FacilityMichael Parks, Niamh O'Dwyer, Jeremy Bollinger, Alan Johnson, Brian Goss, Ned Wyman, Adeyma Arroyo, Joseph Wood and Derek Willison-ParryPDA Journal of Pharmaceutical Science and Technology January 2018, 72 (1) 81-90; DOI: https://doi.org/10.5731/pdajpst.2016.007484
Wood, Joseph
- You have accessElastomer Change Out—Justification for Minimizing the Removal of Elastomers To Prevent Cross-Contamination in a Multiproduct FacilityMichael Parks, Niamh O'Dwyer, Jeremy Bollinger, Alan Johnson, Brian Goss, Ned Wyman, Adeyma Arroyo, Joseph Wood and Derek Willison-ParryPDA Journal of Pharmaceutical Science and Technology January 2018, 72 (1) 81-90; DOI: https://doi.org/10.5731/pdajpst.2016.007484
Wyman, Ned
- You have accessGuidelines for Risk-Based Changeover of Biopharma Multi-Product FacilitiesRob Lynch, David Barabani, Kathy Bellorado, Peter Canisius, Doug Heathcote, Alan Johnson, Ned Wyman and Derek Willison ParryPDA Journal of Pharmaceutical Science and Technology January 2018, 72 (1) 91-103; DOI: https://doi.org/10.5731/pdajpst.2016.007419
- You have accessElastomer Change Out—Justification for Minimizing the Removal of Elastomers To Prevent Cross-Contamination in a Multiproduct FacilityMichael Parks, Niamh O'Dwyer, Jeremy Bollinger, Alan Johnson, Brian Goss, Ned Wyman, Adeyma Arroyo, Joseph Wood and Derek Willison-ParryPDA Journal of Pharmaceutical Science and Technology January 2018, 72 (1) 81-90; DOI: https://doi.org/10.5731/pdajpst.2016.007484
Z
Zapata, Stephanie
- You have accessReal-Time PCR Detection of Burkholderia cepacia in Pharmaceutical Products Contaminated with Low Levels of Bacterial ContaminationLuis Jimenez, Theranda Jashari, Jenifer Vasquez, Stephanie Zapata, Joy Bochis, Margarita Kulko, Victoria Ellman, Matthew Gardner and Tina ChoePDA Journal of Pharmaceutical Science and Technology January 2018, 72 (1) 73-80; DOI: https://doi.org/10.5731/pdajpst.2017.007971
In This Issue
PDA Journal of Pharmaceutical Science and Technology
Vol. 72, Issue 1
January/February 2018
