PDA Journal of Pharmaceutical Science and Technology: 68 (6)

November/December 2014; Volume 68,Issue 6

CONFERENCE PROCEEDING

Introduction-I
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  Introduction and Workshop Summary: Advanced Technologies for Virus Detection in the Evaluation of Biologicals—Applications and Challenges
  Arifa S. Khan and Dominick A. Vacante
  
  PDA Journal of Pharmaceutical Science and Technology November 2014, 68 (6) 546-547; DOI: https://doi.org/10.5731/pdajpst.2014.01028
Introduction-II
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  Summary of the Advanced Virus Detection Technologies Users Group Efforts—2013
  Paul Duncan
  
  PDA Journal of Pharmaceutical Science and Technology November 2014, 68 (6) 548-551; DOI: https://doi.org/10.5731/pdajpst.2014.01018
Needs and Challenges for Using New Technologies
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  The Potential Role of Advanced Technologies for Virus Detection in Development and Regulation of Vaccines
  Shasta D. McClenahan and Philip R. Krause
  
  PDA Journal of Pharmaceutical Science and Technology November 2014, 68 (6) 552-555; DOI: https://doi.org/10.5731/pdajpst.2014.01030
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  Need for New Technologies for Detection of Adventitious Agents in Vaccines and Other Biological Products
  Laurent Mallet and Lucy Gisonni-Lex
  
  PDA Journal of Pharmaceutical Science and Technology November 2014, 68 (6) 556-562; DOI: https://doi.org/10.5731/pdajpst.2014.01012
Performance Evaluation I: Current and New Methods
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  Preliminary Evaluation of Next-Generation Sequencing Performance Relative to qPCR and In Vitro Cell Culture Tests for Human Cytomegalovirus
  Siemon H.S. Ng, Ali Azizi, Kerrie Edamura, Rebecca J. Malott, Robert L. Charlebois, Carine Logvinoff, Martha Schreiber, Laurent Mallet and Lucy Gisonni-Lex
  
  PDA Journal of Pharmaceutical Science and Technology November 2014, 68 (6) 563-571; DOI: https://doi.org/10.5731/pdajpst.2014.01013
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  Parallel Evaluation of Broad Virus Detection Methods
  Jens Modrof, Andreas Berting and Thomas R. Kreil
  
  PDA Journal of Pharmaceutical Science and Technology November 2014, 68 (6) 572-578; DOI: https://doi.org/10.5731/pdajpst.2014.01014
Performance Evaluation II: Technical Considerations
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  Modeling an Approach To Define Sensitivity of Viral Detection in Sample Matrices—Examples with Microarray Readout
  Szi Fei Feng, Crystal Jaing, James B. Thissen, Christopher Wang and Paul Duncan
  
  PDA Journal of Pharmaceutical Science and Technology November 2014, 68 (6) 589-594; DOI: https://doi.org/10.5731/pdajpst.2014.01011
Development and Optimization of Data Analysis Pipelines
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  A Practical Approach to a Viral Detection Pipeline Using Existing Viral and Non-Viral Sequence Resources
  Kavitha Bekkari, Joseph Shpungin and John Ryan Thompson
  
  PDA Journal of Pharmaceutical Science and Technology November 2014, 68 (6) 595-601; DOI: https://doi.org/10.5731/pdajpst.2014.01022
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  Cataloguing the Taxonomic Origins of Sequences from a Heterogeneous Sample Using Phylogenomics: Applications in Adventitious Agent Detection
  Robert L. Charlebois, Siemon H. S. Ng, Lucy Gisonni-Lex and Laurent Mallet
  
  PDA Journal of Pharmaceutical Science and Technology November 2014, 68 (6) 602-618; DOI: https://doi.org/10.5731/pdajpst.2014.01023
Bioinformatics and Databases
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  Bacterial Genome Reference Databases: Progress and Challenges
  Tom Slezak
  
  PDA Journal of Pharmaceutical Science and Technology November 2014, 68 (6) 619-625; DOI: https://doi.org/10.5731/pdajpst.2014.01017
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  FDA's Activities Supporting Regulatory Application of “Next Gen” Sequencing Technologies
  Carolyn A. Wilson and Vahan Simonyan
  
  PDA Journal of Pharmaceutical Science and Technology November 2014, 68 (6) 626-630; DOI: https://doi.org/10.5731/pdajpst.2014.01024
Applications of New Analytical Technologies
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  Whole Genome: Next-Generation Sequencing as a Virus Safety Test for Biotechnological Products
  Eric Cabannes, Charles Hébert and Marc Eloit
  
  PDA Journal of Pharmaceutical Science and Technology November 2014, 68 (6) 631-638; DOI: https://doi.org/10.5731/pdajpst.2014.01015
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  Evaluation of A549 as a New Vaccine Cell Substrate: Digging Deeper with Massively Parallel Sequencing
  Paul Shabram and John L. Kolman
  
  PDA Journal of Pharmaceutical Science and Technology November 2014, 68 (6) 639-650; DOI: https://doi.org/10.5731/pdajpst.2014.01027
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  Detection of Adventitious Agents Using Next-Generation Sequencing
  Brenda Richards, Sherry Cao, Mark Plavsic, Robert Pomponio, Claire Davies, Robert Mattaliano, Stephen Madden, Katherine Klinger and Adam Palermo
  
  PDA Journal of Pharmaceutical Science and Technology November 2014, 68 (6) 651-660; DOI: https://doi.org/10.5731/pdajpst.2014.01025
Novel Viruses: Discoveries and Detection
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  New Technologies and Challenges of Novel Virus Detection
  Arifa S. Khan, Hailun Ma, Lanyn P. Taliaferro, Teresa A. Galvin and Syed Shaheduzzaman
  
  PDA Journal of Pharmaceutical Science and Technology November 2014, 68 (6) 661-666; DOI: https://doi.org/10.5731/pdajpst.2014.01029

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Table of Contents

CONFERENCE PROCEEDING

Introduction-I

Introduction-II

Needs and Challenges for Using New Technologies

Performance Evaluation I: Current and New Methods

Performance Evaluation II: Technical Considerations

Development and Optimization of Data Analysis Pipelines

Bioinformatics and Databases

Applications of New Analytical Technologies

Novel Viruses: Discoveries and Detection

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Parenteral Drug Association, Inc.