Table of Contents

January/February 2015; Volume 69,Issue 1

A

  1. Abe, Yoshihiko

    1. A Strategy for the Prevention of Protein Oxidation by Drug Product in Polymer-Based Syringes
      Koji Nakamura, Yoshihiko Abe, Hideaki Kiminami, Arisa Yamashita, Kazuhiro Iwasaki, Shigeru Suzuki, Keisuke Yoshino, William Dierick and Kevin Constable
      PDA Journal of Pharmaceutical Science and Technology January 2015, 69 (1) 88-95; DOI: https://doi.org/10.5731/pdajpst.2015.01009

  2. Amari, Filippo

    1. Non-Destructive Vacuum Decay Method for Pre-Filled Syringe Closure Integrity Testing Compared with Dye Ingress Testing and High-Voltage Leak Detection
      Andrea Simonetti and Filippo Amari
      PDA Journal of Pharmaceutical Science and Technology January 2015, 69 (1) 108-122; DOI: https://doi.org/10.5731/pdajpst.2015.01004

  3. Ayres, John

    1. Industry Perspective on the Medical Risk of Visible Particles in Injectable Drug Products
      Stan Bukofzer, John Ayres, Anna Chavez, Minerva Devera, Jahanvi Miller, Douglas Ross, John Shabushnig, Susan Vargo, Harry Watson and Rick Watson
      PDA Journal of Pharmaceutical Science and Technology January 2015, 69 (1) 123-139; DOI: https://doi.org/10.5731/pdajpst.2015.01037

B

  1. Ball, Douglas J.

    1. Materials in Manufacturing and Packaging Systems as Sources of Elemental Impurities in Packaged Drug Products: A Literature Review
      Dennis R. Jenke, Cheryl L. M. Stults, Diane M. Paskiet, Douglas J. Ball and Lee M. Nagao
      PDA Journal of Pharmaceutical Science and Technology January 2015, 69 (1) 1-48; DOI: https://doi.org/10.5731/pdajpst.2015.01005

  2. Blümel, Johannes

    1. 2013 Viral Clearance Symposia - Session 5. Conference Summary: Key Discussion and Outcomes, Pending Questions, and Proposed Experiments
      Johannes Blümel and David Roush
      PDA Journal of Pharmaceutical Science and Technology January 2015, 69 (1) 206-210; DOI: https://doi.org/10.5731/pdajpst.2015.01044
    2. Session 4: Overall Integrated Viral Clearance and Adventitious Agents Strategy
      Johannes Blümel and Omar Tounekti
      PDA Journal of Pharmaceutical Science and Technology January 2015, 69 (1) 195-205; DOI: https://doi.org/10.5731/pdajpst.2015.01043

  3. Bowen, Mayumi

    1. Manufacturing of High-Concentration Monoclonal Antibody Formulations via Spray Drying—the Road to Manufacturing Scale
      Benson Gikanga, Robert Turok, Ada Hui, Mayumi Bowen, Oliver B. Stauch and Yuh-Fun Maa
      PDA Journal of Pharmaceutical Science and Technology January 2015, 69 (1) 59-73; DOI: https://doi.org/10.5731/pdajpst.2015.01003

  4. Brorson, Kurt

    1. Proceedings of the 2013 Viral Clearance Symposium (Princeton, NJ)
      David Roush, Kurt Brorson and Rich Levy
      PDA Journal of Pharmaceutical Science and Technology January 2015, 69 (1) 140-141; DOI: https://doi.org/10.5731/pdajpst.2015.01053

  5. Bukofzer, Stan

    1. Industry Perspective on the Medical Risk of Visible Particles in Injectable Drug Products
      Stan Bukofzer, John Ayres, Anna Chavez, Minerva Devera, Jahanvi Miller, Douglas Ross, John Shabushnig, Susan Vargo, Harry Watson and Rick Watson
      PDA Journal of Pharmaceutical Science and Technology January 2015, 69 (1) 123-139; DOI: https://doi.org/10.5731/pdajpst.2015.01037

C

  1. Chavez, Anna

    1. Industry Perspective on the Medical Risk of Visible Particles in Injectable Drug Products
      Stan Bukofzer, John Ayres, Anna Chavez, Minerva Devera, Jahanvi Miller, Douglas Ross, John Shabushnig, Susan Vargo, Harry Watson and Rick Watson
      PDA Journal of Pharmaceutical Science and Technology January 2015, 69 (1) 123-139; DOI: https://doi.org/10.5731/pdajpst.2015.01037

  2. Chen, Dayue

    1. Viral Clearance of Traditional Unit Operations: Virus-Retentive Filtration
      Qi Chen and Dayue Chen
      PDA Journal of Pharmaceutical Science and Technology January 2015, 69 (1) 142-153; DOI: https://doi.org/10.5731/pdajpst.2015.01038

  3. Chen, Qi

    1. Viral Clearance of Traditional Unit Operations: Virus-Retentive Filtration
      Qi Chen and Dayue Chen
      PDA Journal of Pharmaceutical Science and Technology January 2015, 69 (1) 142-153; DOI: https://doi.org/10.5731/pdajpst.2015.01038

  4. Constable, Kevin

    1. A Strategy for the Prevention of Protein Oxidation by Drug Product in Polymer-Based Syringes
      Koji Nakamura, Yoshihiko Abe, Hideaki Kiminami, Arisa Yamashita, Kazuhiro Iwasaki, Shigeru Suzuki, Keisuke Yoshino, William Dierick and Kevin Constable
      PDA Journal of Pharmaceutical Science and Technology January 2015, 69 (1) 88-95; DOI: https://doi.org/10.5731/pdajpst.2015.01009

  5. Coultas, James

    1. Implementation of a High-Throughput Ion Chromatographic Assay To Assess Glass Degradation in Drug Product Formulations
      Renuka Thirumangalathu, Kwun Ngok Wong, James Coultas, Alison Hair and Deirdre Murphy Piedmonte
      PDA Journal of Pharmaceutical Science and Technology January 2015, 69 (1) 96-107; DOI: https://doi.org/10.5731/pdajpst.2015.01007

D

  1. Devera, Minerva

    1. Industry Perspective on the Medical Risk of Visible Particles in Injectable Drug Products
      Stan Bukofzer, John Ayres, Anna Chavez, Minerva Devera, Jahanvi Miller, Douglas Ross, John Shabushnig, Susan Vargo, Harry Watson and Rick Watson
      PDA Journal of Pharmaceutical Science and Technology January 2015, 69 (1) 123-139; DOI: https://doi.org/10.5731/pdajpst.2015.01037

  2. Dierick, William

    1. A Strategy for the Prevention of Protein Oxidation by Drug Product in Polymer-Based Syringes
      Koji Nakamura, Yoshihiko Abe, Hideaki Kiminami, Arisa Yamashita, Kazuhiro Iwasaki, Shigeru Suzuki, Keisuke Yoshino, William Dierick and Kevin Constable
      PDA Journal of Pharmaceutical Science and Technology January 2015, 69 (1) 88-95; DOI: https://doi.org/10.5731/pdajpst.2015.01009

  3. Durno, Laura

    1. Viral Inactivation: Low pH and Detergent
      Laura Durno and Omar Tounekti
      PDA Journal of Pharmaceutical Science and Technology January 2015, 69 (1) 163-172; DOI: https://doi.org/10.5731/pdajpst.2015.01040

F

  1. Fujimori, Kiyoshi

    1. Extractables Analysis of Single-Use Flexible Plastic Biocontainers
      Liliana Marghitoiu, Jian Liu, Hans Lee, Lourdes Perez, Kiyoshi Fujimori, Michael Ronk, Matthew R. Hammond, Heather Nunn, Asher Lower, Gary Rogers and Yasser Nashed-Samuel
      PDA Journal of Pharmaceutical Science and Technology January 2015, 69 (1) 49-58; DOI: https://doi.org/10.5731/pdajpst.2015.01001

G

  1. Gikanga, Benson

    1. Manufacturing of High-Concentration Monoclonal Antibody Formulations via Spray Drying—the Road to Manufacturing Scale
      Benson Gikanga, Robert Turok, Ada Hui, Mayumi Bowen, Oliver B. Stauch and Yuh-Fun Maa
      PDA Journal of Pharmaceutical Science and Technology January 2015, 69 (1) 59-73; DOI: https://doi.org/10.5731/pdajpst.2015.01003

H

  1. Hair, Alison

    1. Implementation of a High-Throughput Ion Chromatographic Assay To Assess Glass Degradation in Drug Product Formulations
      Renuka Thirumangalathu, Kwun Ngok Wong, James Coultas, Alison Hair and Deirdre Murphy Piedmonte
      PDA Journal of Pharmaceutical Science and Technology January 2015, 69 (1) 96-107; DOI: https://doi.org/10.5731/pdajpst.2015.01007

  2. Hammond, Matthew R.

    1. Extractables Analysis of Single-Use Flexible Plastic Biocontainers
      Liliana Marghitoiu, Jian Liu, Hans Lee, Lourdes Perez, Kiyoshi Fujimori, Michael Ronk, Matthew R. Hammond, Heather Nunn, Asher Lower, Gary Rogers and Yasser Nashed-Samuel
      PDA Journal of Pharmaceutical Science and Technology January 2015, 69 (1) 49-58; DOI: https://doi.org/10.5731/pdajpst.2015.01001

  3. Hubbard, Brian

    1. Session 1.5: Other Viral Clearance and Inactivation Approaches (Multimodal Chromatography, Membrane Chromatography, Chemical Precipitation)
      Brian Hubbard
      PDA Journal of Pharmaceutical Science and Technology January 2015, 69 (1) 173-182; DOI: https://doi.org/10.5731/pdajpst.2015.01041

  4. Hui, Ada

    1. Manufacturing of High-Concentration Monoclonal Antibody Formulations via Spray Drying—the Road to Manufacturing Scale
      Benson Gikanga, Robert Turok, Ada Hui, Mayumi Bowen, Oliver B. Stauch and Yuh-Fun Maa
      PDA Journal of Pharmaceutical Science and Technology January 2015, 69 (1) 59-73; DOI: https://doi.org/10.5731/pdajpst.2015.01003

I

  1. Iwasaki, Kazuhiro

    1. A Strategy for the Prevention of Protein Oxidation by Drug Product in Polymer-Based Syringes
      Koji Nakamura, Yoshihiko Abe, Hideaki Kiminami, Arisa Yamashita, Kazuhiro Iwasaki, Shigeru Suzuki, Keisuke Yoshino, William Dierick and Kevin Constable
      PDA Journal of Pharmaceutical Science and Technology January 2015, 69 (1) 88-95; DOI: https://doi.org/10.5731/pdajpst.2015.01009

J

  1. Jenke, Dennis R.

    1. Materials in Manufacturing and Packaging Systems as Sources of Elemental Impurities in Packaged Drug Products: A Literature Review
      Dennis R. Jenke, Cheryl L. M. Stults, Diane M. Paskiet, Douglas J. Ball and Lee M. Nagao
      PDA Journal of Pharmaceutical Science and Technology January 2015, 69 (1) 1-48; DOI: https://doi.org/10.5731/pdajpst.2015.01005

K

  1. Kiminami, Hideaki

    1. A Strategy for the Prevention of Protein Oxidation by Drug Product in Polymer-Based Syringes
      Koji Nakamura, Yoshihiko Abe, Hideaki Kiminami, Arisa Yamashita, Kazuhiro Iwasaki, Shigeru Suzuki, Keisuke Yoshino, William Dierick and Kevin Constable
      PDA Journal of Pharmaceutical Science and Technology January 2015, 69 (1) 88-95; DOI: https://doi.org/10.5731/pdajpst.2015.01009

  2. Kumar, Anil

    1. Scale-up of Sterilizing-grade Membrane Filters from Discs to Pleated Cartridges: Effects of Operating Parameters and Solution Properties
      Anil Kumar, Jerold Martin and Ralf Kuriyel
      PDA Journal of Pharmaceutical Science and Technology January 2015, 69 (1) 74-87; DOI: https://doi.org/10.5731/pdajpst.2015.01006

  3. Kuriyel, Ralf

    1. Scale-up of Sterilizing-grade Membrane Filters from Discs to Pleated Cartridges: Effects of Operating Parameters and Solution Properties
      Anil Kumar, Jerold Martin and Ralf Kuriyel
      PDA Journal of Pharmaceutical Science and Technology January 2015, 69 (1) 74-87; DOI: https://doi.org/10.5731/pdajpst.2015.01006

L

  1. Lee, Hans

    1. Extractables Analysis of Single-Use Flexible Plastic Biocontainers
      Liliana Marghitoiu, Jian Liu, Hans Lee, Lourdes Perez, Kiyoshi Fujimori, Michael Ronk, Matthew R. Hammond, Heather Nunn, Asher Lower, Gary Rogers and Yasser Nashed-Samuel
      PDA Journal of Pharmaceutical Science and Technology January 2015, 69 (1) 49-58; DOI: https://doi.org/10.5731/pdajpst.2015.01001

  2. Levy, Rich

    1. Proceedings of the 2013 Viral Clearance Symposium (Princeton, NJ)
      David Roush, Kurt Brorson and Rich Levy
      PDA Journal of Pharmaceutical Science and Technology January 2015, 69 (1) 140-141; DOI: https://doi.org/10.5731/pdajpst.2015.01053

  3. Liu, Jian

    1. Extractables Analysis of Single-Use Flexible Plastic Biocontainers
      Liliana Marghitoiu, Jian Liu, Hans Lee, Lourdes Perez, Kiyoshi Fujimori, Michael Ronk, Matthew R. Hammond, Heather Nunn, Asher Lower, Gary Rogers and Yasser Nashed-Samuel
      PDA Journal of Pharmaceutical Science and Technology January 2015, 69 (1) 49-58; DOI: https://doi.org/10.5731/pdajpst.2015.01001

  4. Lower, Asher

    1. Extractables Analysis of Single-Use Flexible Plastic Biocontainers
      Liliana Marghitoiu, Jian Liu, Hans Lee, Lourdes Perez, Kiyoshi Fujimori, Michael Ronk, Matthew R. Hammond, Heather Nunn, Asher Lower, Gary Rogers and Yasser Nashed-Samuel
      PDA Journal of Pharmaceutical Science and Technology January 2015, 69 (1) 49-58; DOI: https://doi.org/10.5731/pdajpst.2015.01001

M

  1. Maa, Yuh-Fun

    1. Manufacturing of High-Concentration Monoclonal Antibody Formulations via Spray Drying—the Road to Manufacturing Scale
      Benson Gikanga, Robert Turok, Ada Hui, Mayumi Bowen, Oliver B. Stauch and Yuh-Fun Maa
      PDA Journal of Pharmaceutical Science and Technology January 2015, 69 (1) 59-73; DOI: https://doi.org/10.5731/pdajpst.2015.01003

  2. Marghitoiu, Liliana

    1. Extractables Analysis of Single-Use Flexible Plastic Biocontainers
      Liliana Marghitoiu, Jian Liu, Hans Lee, Lourdes Perez, Kiyoshi Fujimori, Michael Ronk, Matthew R. Hammond, Heather Nunn, Asher Lower, Gary Rogers and Yasser Nashed-Samuel
      PDA Journal of Pharmaceutical Science and Technology January 2015, 69 (1) 49-58; DOI: https://doi.org/10.5731/pdajpst.2015.01001

  3. Martin, Jerold

    1. Scale-up of Sterilizing-grade Membrane Filters from Discs to Pleated Cartridges: Effects of Operating Parameters and Solution Properties
      Anil Kumar, Jerold Martin and Ralf Kuriyel
      PDA Journal of Pharmaceutical Science and Technology January 2015, 69 (1) 74-87; DOI: https://doi.org/10.5731/pdajpst.2015.01006

  4. Miller, Jahanvi

    1. Industry Perspective on the Medical Risk of Visible Particles in Injectable Drug Products
      Stan Bukofzer, John Ayres, Anna Chavez, Minerva Devera, Jahanvi Miller, Douglas Ross, John Shabushnig, Susan Vargo, Harry Watson and Rick Watson
      PDA Journal of Pharmaceutical Science and Technology January 2015, 69 (1) 123-139; DOI: https://doi.org/10.5731/pdajpst.2015.01037

N

  1. Nagao, Lee M.

    1. Materials in Manufacturing and Packaging Systems as Sources of Elemental Impurities in Packaged Drug Products: A Literature Review
      Dennis R. Jenke, Cheryl L. M. Stults, Diane M. Paskiet, Douglas J. Ball and Lee M. Nagao
      PDA Journal of Pharmaceutical Science and Technology January 2015, 69 (1) 1-48; DOI: https://doi.org/10.5731/pdajpst.2015.01005

  2. Nakamura, Koji

    1. A Strategy for the Prevention of Protein Oxidation by Drug Product in Polymer-Based Syringes
      Koji Nakamura, Yoshihiko Abe, Hideaki Kiminami, Arisa Yamashita, Kazuhiro Iwasaki, Shigeru Suzuki, Keisuke Yoshino, William Dierick and Kevin Constable
      PDA Journal of Pharmaceutical Science and Technology January 2015, 69 (1) 88-95; DOI: https://doi.org/10.5731/pdajpst.2015.01009

  3. Nashed-Samuel, Yasser

    1. Extractables Analysis of Single-Use Flexible Plastic Biocontainers
      Liliana Marghitoiu, Jian Liu, Hans Lee, Lourdes Perez, Kiyoshi Fujimori, Michael Ronk, Matthew R. Hammond, Heather Nunn, Asher Lower, Gary Rogers and Yasser Nashed-Samuel
      PDA Journal of Pharmaceutical Science and Technology January 2015, 69 (1) 49-58; DOI: https://doi.org/10.5731/pdajpst.2015.01001

  4. Nunn, Heather

    1. Extractables Analysis of Single-Use Flexible Plastic Biocontainers
      Liliana Marghitoiu, Jian Liu, Hans Lee, Lourdes Perez, Kiyoshi Fujimori, Michael Ronk, Matthew R. Hammond, Heather Nunn, Asher Lower, Gary Rogers and Yasser Nashed-Samuel
      PDA Journal of Pharmaceutical Science and Technology January 2015, 69 (1) 49-58; DOI: https://doi.org/10.5731/pdajpst.2015.01001

P

  1. Paskiet, Diane M.

    1. Materials in Manufacturing and Packaging Systems as Sources of Elemental Impurities in Packaged Drug Products: A Literature Review
      Dennis R. Jenke, Cheryl L. M. Stults, Diane M. Paskiet, Douglas J. Ball and Lee M. Nagao
      PDA Journal of Pharmaceutical Science and Technology January 2015, 69 (1) 1-48; DOI: https://doi.org/10.5731/pdajpst.2015.01005

  2. Perez, Lourdes

    1. Extractables Analysis of Single-Use Flexible Plastic Biocontainers
      Liliana Marghitoiu, Jian Liu, Hans Lee, Lourdes Perez, Kiyoshi Fujimori, Michael Ronk, Matthew R. Hammond, Heather Nunn, Asher Lower, Gary Rogers and Yasser Nashed-Samuel
      PDA Journal of Pharmaceutical Science and Technology January 2015, 69 (1) 49-58; DOI: https://doi.org/10.5731/pdajpst.2015.01001

  3. Piedmonte, Deirdre Murphy

    1. Implementation of a High-Throughput Ion Chromatographic Assay To Assess Glass Degradation in Drug Product Formulations
      Renuka Thirumangalathu, Kwun Ngok Wong, James Coultas, Alison Hair and Deirdre Murphy Piedmonte
      PDA Journal of Pharmaceutical Science and Technology January 2015, 69 (1) 96-107; DOI: https://doi.org/10.5731/pdajpst.2015.01007

R

  1. Rogers, Gary

    1. Extractables Analysis of Single-Use Flexible Plastic Biocontainers
      Liliana Marghitoiu, Jian Liu, Hans Lee, Lourdes Perez, Kiyoshi Fujimori, Michael Ronk, Matthew R. Hammond, Heather Nunn, Asher Lower, Gary Rogers and Yasser Nashed-Samuel
      PDA Journal of Pharmaceutical Science and Technology January 2015, 69 (1) 49-58; DOI: https://doi.org/10.5731/pdajpst.2015.01001

  2. Ronk, Michael

    1. Extractables Analysis of Single-Use Flexible Plastic Biocontainers
      Liliana Marghitoiu, Jian Liu, Hans Lee, Lourdes Perez, Kiyoshi Fujimori, Michael Ronk, Matthew R. Hammond, Heather Nunn, Asher Lower, Gary Rogers and Yasser Nashed-Samuel
      PDA Journal of Pharmaceutical Science and Technology January 2015, 69 (1) 49-58; DOI: https://doi.org/10.5731/pdajpst.2015.01001

  3. Ross, Douglas

    1. Industry Perspective on the Medical Risk of Visible Particles in Injectable Drug Products
      Stan Bukofzer, John Ayres, Anna Chavez, Minerva Devera, Jahanvi Miller, Douglas Ross, John Shabushnig, Susan Vargo, Harry Watson and Rick Watson
      PDA Journal of Pharmaceutical Science and Technology January 2015, 69 (1) 123-139; DOI: https://doi.org/10.5731/pdajpst.2015.01037

  4. Roush, David

    1. 2013 Viral Clearance Symposia - Session 5. Conference Summary: Key Discussion and Outcomes, Pending Questions, and Proposed Experiments
      Johannes Blümel and David Roush
      PDA Journal of Pharmaceutical Science and Technology January 2015, 69 (1) 206-210; DOI: https://doi.org/10.5731/pdajpst.2015.01044
    2. Proceedings of the 2013 Viral Clearance Symposium (Princeton, NJ)
      David Roush, Kurt Brorson and Rich Levy
      PDA Journal of Pharmaceutical Science and Technology January 2015, 69 (1) 140-141; DOI: https://doi.org/10.5731/pdajpst.2015.01053
    3. Viral Clearance Using Traditional, Well-Understood Unit Operations: Session 1.2. Anion Exchange Chromatography; and Session 1.3. Protein A Chromatography
      David Roush
      PDA Journal of Pharmaceutical Science and Technology January 2015, 69 (1) 154-162; DOI: https://doi.org/10.5731/pdajpst.2015.01039

S

  1. Shabushnig, John

    1. Industry Perspective on the Medical Risk of Visible Particles in Injectable Drug Products
      Stan Bukofzer, John Ayres, Anna Chavez, Minerva Devera, Jahanvi Miller, Douglas Ross, John Shabushnig, Susan Vargo, Harry Watson and Rick Watson
      PDA Journal of Pharmaceutical Science and Technology January 2015, 69 (1) 123-139; DOI: https://doi.org/10.5731/pdajpst.2015.01037

  2. Simonetti, Andrea

    1. Non-Destructive Vacuum Decay Method for Pre-Filled Syringe Closure Integrity Testing Compared with Dye Ingress Testing and High-Voltage Leak Detection
      Andrea Simonetti and Filippo Amari
      PDA Journal of Pharmaceutical Science and Technology January 2015, 69 (1) 108-122; DOI: https://doi.org/10.5731/pdajpst.2015.01004

  3. Stauch, Oliver B.

    1. Manufacturing of High-Concentration Monoclonal Antibody Formulations via Spray Drying—the Road to Manufacturing Scale
      Benson Gikanga, Robert Turok, Ada Hui, Mayumi Bowen, Oliver B. Stauch and Yuh-Fun Maa
      PDA Journal of Pharmaceutical Science and Technology January 2015, 69 (1) 59-73; DOI: https://doi.org/10.5731/pdajpst.2015.01003

  4. Stults, Cheryl L. M.

    1. Materials in Manufacturing and Packaging Systems as Sources of Elemental Impurities in Packaged Drug Products: A Literature Review
      Dennis R. Jenke, Cheryl L. M. Stults, Diane M. Paskiet, Douglas J. Ball and Lee M. Nagao
      PDA Journal of Pharmaceutical Science and Technology January 2015, 69 (1) 1-48; DOI: https://doi.org/10.5731/pdajpst.2015.01005

  5. Suzuki, Shigeru

    1. A Strategy for the Prevention of Protein Oxidation by Drug Product in Polymer-Based Syringes
      Koji Nakamura, Yoshihiko Abe, Hideaki Kiminami, Arisa Yamashita, Kazuhiro Iwasaki, Shigeru Suzuki, Keisuke Yoshino, William Dierick and Kevin Constable
      PDA Journal of Pharmaceutical Science and Technology January 2015, 69 (1) 88-95; DOI: https://doi.org/10.5731/pdajpst.2015.01009

T

  1. Thirumangalathu, Renuka

    1. Implementation of a High-Throughput Ion Chromatographic Assay To Assess Glass Degradation in Drug Product Formulations
      Renuka Thirumangalathu, Kwun Ngok Wong, James Coultas, Alison Hair and Deirdre Murphy Piedmonte
      PDA Journal of Pharmaceutical Science and Technology January 2015, 69 (1) 96-107; DOI: https://doi.org/10.5731/pdajpst.2015.01007

  2. Tounekti, Omar

    1. Viral Inactivation: Low pH and Detergent
      Laura Durno and Omar Tounekti
      PDA Journal of Pharmaceutical Science and Technology January 2015, 69 (1) 163-172; DOI: https://doi.org/10.5731/pdajpst.2015.01040
    2. Session 4: Overall Integrated Viral Clearance and Adventitious Agents Strategy
      Johannes Blümel and Omar Tounekti
      PDA Journal of Pharmaceutical Science and Technology January 2015, 69 (1) 195-205; DOI: https://doi.org/10.5731/pdajpst.2015.01043

  3. Turok, Robert

    1. Manufacturing of High-Concentration Monoclonal Antibody Formulations via Spray Drying—the Road to Manufacturing Scale
      Benson Gikanga, Robert Turok, Ada Hui, Mayumi Bowen, Oliver B. Stauch and Yuh-Fun Maa
      PDA Journal of Pharmaceutical Science and Technology January 2015, 69 (1) 59-73; DOI: https://doi.org/10.5731/pdajpst.2015.01003

V

  1. Vargo, Susan

    1. Industry Perspective on the Medical Risk of Visible Particles in Injectable Drug Products
      Stan Bukofzer, John Ayres, Anna Chavez, Minerva Devera, Jahanvi Miller, Douglas Ross, John Shabushnig, Susan Vargo, Harry Watson and Rick Watson
      PDA Journal of Pharmaceutical Science and Technology January 2015, 69 (1) 123-139; DOI: https://doi.org/10.5731/pdajpst.2015.01037

W

  1. Watson, Harry

    1. Industry Perspective on the Medical Risk of Visible Particles in Injectable Drug Products
      Stan Bukofzer, John Ayres, Anna Chavez, Minerva Devera, Jahanvi Miller, Douglas Ross, John Shabushnig, Susan Vargo, Harry Watson and Rick Watson
      PDA Journal of Pharmaceutical Science and Technology January 2015, 69 (1) 123-139; DOI: https://doi.org/10.5731/pdajpst.2015.01037

  2. Watson, Rick

    1. Industry Perspective on the Medical Risk of Visible Particles in Injectable Drug Products
      Stan Bukofzer, John Ayres, Anna Chavez, Minerva Devera, Jahanvi Miller, Douglas Ross, John Shabushnig, Susan Vargo, Harry Watson and Rick Watson
      PDA Journal of Pharmaceutical Science and Technology January 2015, 69 (1) 123-139; DOI: https://doi.org/10.5731/pdajpst.2015.01037

  3. Willkommen, Hannelore

    1. Session 2/3: Integrated Viral Clearance Strategy and Case Studies
      Hannelore Willkommen
      PDA Journal of Pharmaceutical Science and Technology January 2015, 69 (1) 183-194; DOI: https://doi.org/10.5731/pdajpst.2015.01042

  4. Wong, Kwun Ngok

    1. Implementation of a High-Throughput Ion Chromatographic Assay To Assess Glass Degradation in Drug Product Formulations
      Renuka Thirumangalathu, Kwun Ngok Wong, James Coultas, Alison Hair and Deirdre Murphy Piedmonte
      PDA Journal of Pharmaceutical Science and Technology January 2015, 69 (1) 96-107; DOI: https://doi.org/10.5731/pdajpst.2015.01007

Y

  1. Yamashita, Arisa

    1. A Strategy for the Prevention of Protein Oxidation by Drug Product in Polymer-Based Syringes
      Koji Nakamura, Yoshihiko Abe, Hideaki Kiminami, Arisa Yamashita, Kazuhiro Iwasaki, Shigeru Suzuki, Keisuke Yoshino, William Dierick and Kevin Constable
      PDA Journal of Pharmaceutical Science and Technology January 2015, 69 (1) 88-95; DOI: https://doi.org/10.5731/pdajpst.2015.01009

  2. Yoshino, Keisuke

    1. A Strategy for the Prevention of Protein Oxidation by Drug Product in Polymer-Based Syringes
      Koji Nakamura, Yoshihiko Abe, Hideaki Kiminami, Arisa Yamashita, Kazuhiro Iwasaki, Shigeru Suzuki, Keisuke Yoshino, William Dierick and Kevin Constable
      PDA Journal of Pharmaceutical Science and Technology January 2015, 69 (1) 88-95; DOI: https://doi.org/10.5731/pdajpst.2015.01009
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