Table of Contents

January/February 2021; Volume 75,Issue 1

A

  1. Authelin, Jean-RenÉ

    1. Freezing Time Prediction of Biologic Formulated Drug Substance Using the Plank Model
      Mostafa Nakach, Firas Bahloul, StÉphanie Greco, Jean-RenÉ Authelin, Otmar Klingler and Cathrin Bernhardt
      PDA Journal of Pharmaceutical Science and Technology January 2021, 75 (1) 24-32; DOI: https://doi.org/10.5731/pdajpst.2019.011247

B

  1. Bahloul, Firas

    1. Freezing Time Prediction of Biologic Formulated Drug Substance Using the Plank Model
      Mostafa Nakach, Firas Bahloul, StÉphanie Greco, Jean-RenÉ Authelin, Otmar Klingler and Cathrin Bernhardt
      PDA Journal of Pharmaceutical Science and Technology January 2021, 75 (1) 24-32; DOI: https://doi.org/10.5731/pdajpst.2019.011247

  2. Bernhardt, Cathrin

    1. Freezing Time Prediction of Biologic Formulated Drug Substance Using the Plank Model
      Mostafa Nakach, Firas Bahloul, StÉphanie Greco, Jean-RenÉ Authelin, Otmar Klingler and Cathrin Bernhardt
      PDA Journal of Pharmaceutical Science and Technology January 2021, 75 (1) 24-32; DOI: https://doi.org/10.5731/pdajpst.2019.011247

  3. Braybrook, Julian

    1. Quantifying Operator Subjectivity within Flow Cytometry Data Analysis as a Source of Measurement Uncertainty and the Impact of Experience on Results
      Rebecca Grant, Karen Coopman, Nicholas Medcalf, Sandro Silva-Gomes, Jonathan J. Campbell, Bo Kara, Julian Braybrook and Jon Petzing
      PDA Journal of Pharmaceutical Science and Technology January 2021, 75 (1) 33-47; DOI: https://doi.org/10.5731/pdajpst.2019.011213

C

  1. Calnan, Nuala

    1. Knowledge Management as a Pharmaceutical Quality System Enabler: How Enhanced Knowledge Transfer Can Help Close the ICH Q10 to ICH Q12 Gap
      Martin J. Lipa, Anne Greene and Nuala Calnan
      PDA Journal of Pharmaceutical Science and Technology January 2021, 75 (1) 64-90; DOI: https://doi.org/10.5731/pdajpst.2020.011825

  2. Campbell, Jonathan J.

    1. Quantifying Operator Subjectivity within Flow Cytometry Data Analysis as a Source of Measurement Uncertainty and the Impact of Experience on Results
      Rebecca Grant, Karen Coopman, Nicholas Medcalf, Sandro Silva-Gomes, Jonathan J. Campbell, Bo Kara, Julian Braybrook and Jon Petzing
      PDA Journal of Pharmaceutical Science and Technology January 2021, 75 (1) 33-47; DOI: https://doi.org/10.5731/pdajpst.2019.011213

  3. Chakraborty, Subrata

    1. Alternate Approach for Defining Worst Case in Steam Sterilization Validation of Porous/Hard Goods Loads
      Subrata Chakraborty, Vaidehi Soman and Vinayak Dhumal
      PDA Journal of Pharmaceutical Science and Technology January 2021, 75 (1) 91-99; DOI: https://doi.org/10.5731/pdajpst.2019.011304

  4. Christian, Elizabeth

    1. A Bayesian Statistical Approach to Continuous Qualification of a Bioassay
      Steven J. Novick, Elizabeth Christian, Erika Farmer and Max Tejada
      PDA Journal of Pharmaceutical Science and Technology January 2021, 75 (1) 8-23; DOI: https://doi.org/10.5731/pdajpst.2019.011221

  5. Coopman, Karen

    1. Quantifying Operator Subjectivity within Flow Cytometry Data Analysis as a Source of Measurement Uncertainty and the Impact of Experience on Results
      Rebecca Grant, Karen Coopman, Nicholas Medcalf, Sandro Silva-Gomes, Jonathan J. Campbell, Bo Kara, Julian Braybrook and Jon Petzing
      PDA Journal of Pharmaceutical Science and Technology January 2021, 75 (1) 33-47; DOI: https://doi.org/10.5731/pdajpst.2019.011213

D

  1. Dhumal, Vinayak

    1. Alternate Approach for Defining Worst Case in Steam Sterilization Validation of Porous/Hard Goods Loads
      Subrata Chakraborty, Vaidehi Soman and Vinayak Dhumal
      PDA Journal of Pharmaceutical Science and Technology January 2021, 75 (1) 91-99; DOI: https://doi.org/10.5731/pdajpst.2019.011304

F

  1. Farmer, Erika

    1. A Bayesian Statistical Approach to Continuous Qualification of a Bioassay
      Steven J. Novick, Elizabeth Christian, Erika Farmer and Max Tejada
      PDA Journal of Pharmaceutical Science and Technology January 2021, 75 (1) 8-23; DOI: https://doi.org/10.5731/pdajpst.2019.011221

  2. Fernàndez, Cristina

    1. Artificial Intelligence Algorithm Qualification: A Quality by Design Approach to Apply Artificial Intelligence in Pharma
      Toni Manzano, Cristina Fernàndez, Toni Ruiz and Hugo Richard
      PDA Journal of Pharmaceutical Science and Technology January 2021, 75 (1) 100-118; DOI: https://doi.org/10.5731/pdajpst.2019.011338

G

  1. Grant, Rebecca

    1. Quantifying Operator Subjectivity within Flow Cytometry Data Analysis as a Source of Measurement Uncertainty and the Impact of Experience on Results
      Rebecca Grant, Karen Coopman, Nicholas Medcalf, Sandro Silva-Gomes, Jonathan J. Campbell, Bo Kara, Julian Braybrook and Jon Petzing
      PDA Journal of Pharmaceutical Science and Technology January 2021, 75 (1) 33-47; DOI: https://doi.org/10.5731/pdajpst.2019.011213

  2. Greco, StÉphanie

    1. Freezing Time Prediction of Biologic Formulated Drug Substance Using the Plank Model
      Mostafa Nakach, Firas Bahloul, StÉphanie Greco, Jean-RenÉ Authelin, Otmar Klingler and Cathrin Bernhardt
      PDA Journal of Pharmaceutical Science and Technology January 2021, 75 (1) 24-32; DOI: https://doi.org/10.5731/pdajpst.2019.011247

  3. Greene, Anne

    1. Knowledge Management as a Pharmaceutical Quality System Enabler: How Enhanced Knowledge Transfer Can Help Close the ICH Q10 to ICH Q12 Gap
      Martin J. Lipa, Anne Greene and Nuala Calnan
      PDA Journal of Pharmaceutical Science and Technology January 2021, 75 (1) 64-90; DOI: https://doi.org/10.5731/pdajpst.2020.011825

K

  1. Kara, Bo

    1. Quantifying Operator Subjectivity within Flow Cytometry Data Analysis as a Source of Measurement Uncertainty and the Impact of Experience on Results
      Rebecca Grant, Karen Coopman, Nicholas Medcalf, Sandro Silva-Gomes, Jonathan J. Campbell, Bo Kara, Julian Braybrook and Jon Petzing
      PDA Journal of Pharmaceutical Science and Technology January 2021, 75 (1) 33-47; DOI: https://doi.org/10.5731/pdajpst.2019.011213

  2. Klingler, Otmar

    1. Freezing Time Prediction of Biologic Formulated Drug Substance Using the Plank Model
      Mostafa Nakach, Firas Bahloul, StÉphanie Greco, Jean-RenÉ Authelin, Otmar Klingler and Cathrin Bernhardt
      PDA Journal of Pharmaceutical Science and Technology January 2021, 75 (1) 24-32; DOI: https://doi.org/10.5731/pdajpst.2019.011247

L

  1. Lee, Kelvin H.

    1. Summary from Advanced Manufacturing Technology Workshop Held at 6th Accelerating Biopharmaceutical Development Meeting
      Kelvin H. Lee and Jennifer L. Mantle
      PDA Journal of Pharmaceutical Science and Technology January 2021, 75 (1) 48-63; DOI: https://doi.org/10.5731/pdajpst.2020.011429

  2. Lipa, Martin J.

    1. Knowledge Management as a Pharmaceutical Quality System Enabler: How Enhanced Knowledge Transfer Can Help Close the ICH Q10 to ICH Q12 Gap
      Martin J. Lipa, Anne Greene and Nuala Calnan
      PDA Journal of Pharmaceutical Science and Technology January 2021, 75 (1) 64-90; DOI: https://doi.org/10.5731/pdajpst.2020.011825

M

  1. Mantle, Jennifer L.

    1. Summary from Advanced Manufacturing Technology Workshop Held at 6th Accelerating Biopharmaceutical Development Meeting
      Kelvin H. Lee and Jennifer L. Mantle
      PDA Journal of Pharmaceutical Science and Technology January 2021, 75 (1) 48-63; DOI: https://doi.org/10.5731/pdajpst.2020.011429

  2. Manzano, Toni

    1. Artificial Intelligence Algorithm Qualification: A Quality by Design Approach to Apply Artificial Intelligence in Pharma
      Toni Manzano, Cristina Fernàndez, Toni Ruiz and Hugo Richard
      PDA Journal of Pharmaceutical Science and Technology January 2021, 75 (1) 100-118; DOI: https://doi.org/10.5731/pdajpst.2019.011338

  3. Medcalf, Nicholas

    1. Quantifying Operator Subjectivity within Flow Cytometry Data Analysis as a Source of Measurement Uncertainty and the Impact of Experience on Results
      Rebecca Grant, Karen Coopman, Nicholas Medcalf, Sandro Silva-Gomes, Jonathan J. Campbell, Bo Kara, Julian Braybrook and Jon Petzing
      PDA Journal of Pharmaceutical Science and Technology January 2021, 75 (1) 33-47; DOI: https://doi.org/10.5731/pdajpst.2019.011213

N

  1. Nakach, Mostafa

    1. Freezing Time Prediction of Biologic Formulated Drug Substance Using the Plank Model
      Mostafa Nakach, Firas Bahloul, StÉphanie Greco, Jean-RenÉ Authelin, Otmar Klingler and Cathrin Bernhardt
      PDA Journal of Pharmaceutical Science and Technology January 2021, 75 (1) 24-32; DOI: https://doi.org/10.5731/pdajpst.2019.011247

  2. Novick, Steven J.

    1. A Bayesian Statistical Approach to Continuous Qualification of a Bioassay
      Steven J. Novick, Elizabeth Christian, Erika Farmer and Max Tejada
      PDA Journal of Pharmaceutical Science and Technology January 2021, 75 (1) 8-23; DOI: https://doi.org/10.5731/pdajpst.2019.011221

P

  1. Petzing, Jon

    1. Quantifying Operator Subjectivity within Flow Cytometry Data Analysis as a Source of Measurement Uncertainty and the Impact of Experience on Results
      Rebecca Grant, Karen Coopman, Nicholas Medcalf, Sandro Silva-Gomes, Jonathan J. Campbell, Bo Kara, Julian Braybrook and Jon Petzing
      PDA Journal of Pharmaceutical Science and Technology January 2021, 75 (1) 33-47; DOI: https://doi.org/10.5731/pdajpst.2019.011213

R

  1. Richard, Hugo

    1. Artificial Intelligence Algorithm Qualification: A Quality by Design Approach to Apply Artificial Intelligence in Pharma
      Toni Manzano, Cristina Fernàndez, Toni Ruiz and Hugo Richard
      PDA Journal of Pharmaceutical Science and Technology January 2021, 75 (1) 100-118; DOI: https://doi.org/10.5731/pdajpst.2019.011338

  2. Ruiz, Toni

    1. Artificial Intelligence Algorithm Qualification: A Quality by Design Approach to Apply Artificial Intelligence in Pharma
      Toni Manzano, Cristina Fernàndez, Toni Ruiz and Hugo Richard
      PDA Journal of Pharmaceutical Science and Technology January 2021, 75 (1) 100-118; DOI: https://doi.org/10.5731/pdajpst.2019.011338

S

  1. Silva-Gomes, Sandro

    1. Quantifying Operator Subjectivity within Flow Cytometry Data Analysis as a Source of Measurement Uncertainty and the Impact of Experience on Results
      Rebecca Grant, Karen Coopman, Nicholas Medcalf, Sandro Silva-Gomes, Jonathan J. Campbell, Bo Kara, Julian Braybrook and Jon Petzing
      PDA Journal of Pharmaceutical Science and Technology January 2021, 75 (1) 33-47; DOI: https://doi.org/10.5731/pdajpst.2019.011213

  2. Soman, Vaidehi

    1. Alternate Approach for Defining Worst Case in Steam Sterilization Validation of Porous/Hard Goods Loads
      Subrata Chakraborty, Vaidehi Soman and Vinayak Dhumal
      PDA Journal of Pharmaceutical Science and Technology January 2021, 75 (1) 91-99; DOI: https://doi.org/10.5731/pdajpst.2019.011304

T

  1. Tejada, Max

    1. A Bayesian Statistical Approach to Continuous Qualification of a Bioassay
      Steven J. Novick, Elizabeth Christian, Erika Farmer and Max Tejada
      PDA Journal of Pharmaceutical Science and Technology January 2021, 75 (1) 8-23; DOI: https://doi.org/10.5731/pdajpst.2019.011221

  2. Tindall, Brendan

    1. Response to the Guest Editorial “Scientific Studies and Interpretation”
      Brendan Tindall
      PDA Journal of Pharmaceutical Science and Technology January 2021, 75 (1) 4-7; DOI: https://doi.org/10.5731/pdajpst.2020.012484

Z

  1. Zdravkovic, Steven A.

    1. Assessment of Extractable and Leachable Substances from Pharmaceutical Contact Materials: Where Are We and Where Do We Go from Here?
      Steven A. Zdravkovic
      PDA Journal of Pharmaceutical Science and Technology January 2021, 75 (1) 1-3; DOI: https://doi.org/10.5731/pdajpst.2021.012328
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