Quality by Design for Biopharmaceutical Drug Product Development - AAPS Advances in the Pharmaceutical Sciences Series
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Published By Springer New York

9781493923151, 9781493923168

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Regulatory Considerations for Implementation of the QbD Paradigm for Biologics: Laying the Foundation for Product and Process Lifecycle Management

Quality by Design for Biopharmaceutical Drug Product Development - AAPS Advances in the Pharmaceutical Sciences Series ◽

10.1007/978-1-4939-2316-8_28 ◽

2015 ◽

pp. 693-705 ◽

Cited By ~ 1

Author(s):

Lynne Krummen

Keyword(s):

Product And Process ◽

Lifecycle Management

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Quality by Design for Distribution of Environmentally Sensitive Pharmaceutical Products

Quality by Design for Biopharmaceutical Drug Product Development - AAPS Advances in the Pharmaceutical Sciences Series ◽

10.1007/978-1-4939-2316-8_16 ◽

2015 ◽

pp. 353-363

Author(s):

Paul Harber

Keyword(s):

Quality By Design ◽

Pharmaceutical Products ◽

Environmentally Sensitive

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Application of Multivariate Statistical Process Monitoring to Lyophilization Process

Quality by Design for Biopharmaceutical Drug Product Development - AAPS Advances in the Pharmaceutical Sciences Series ◽

10.1007/978-1-4939-2316-8_24 ◽

2015 ◽

pp. 595-603

Author(s):

Fuat Doymaz

Keyword(s):

Process Monitoring ◽

Multivariate Statistical ◽

Statistical Process ◽

Multivariate Statistical Process Monitoring ◽

Statistical Process Monitoring

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Application of QbD Elements in the Development and Scale-up of Commercial Filling Process

Quality by Design for Biopharmaceutical Drug Product Development - AAPS Advances in the Pharmaceutical Sciences Series ◽

10.1007/978-1-4939-2316-8_13 ◽

2015 ◽

pp. 265-302

Author(s):

Feroz Jameel ◽

Cenk Undey ◽

Paul M. Kovach ◽

Jart Tanglertpaibul

Keyword(s):

Scale Up ◽

Filling Process

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Quality by Design for Primary Container Components

Quality by Design for Biopharmaceutical Drug Product Development - AAPS Advances in the Pharmaceutical Sciences Series ◽

10.1007/978-1-4939-2316-8_17 ◽

2015 ◽

pp. 365-401

Author(s):

Fran DeGrazio ◽

Lionel Vedrine

Keyword(s):

Quality By Design

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Quality by Design as Applied to Drug Substance Formulation Using Ultrafiltration and Diafiltration

Quality by Design for Biopharmaceutical Drug Product Development - AAPS Advances in the Pharmaceutical Sciences Series ◽

10.1007/978-1-4939-2316-8_10 ◽

2015 ◽

pp. 191-210

Author(s):

Joseph Edward Shultz ◽

Herb Lutz ◽

Suma Rao

Keyword(s):

Quality By Design ◽

Drug Substance

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A QbD Approach in the Development and Scale-Up of Mixing Processes

Quality by Design for Biopharmaceutical Drug Product Development - AAPS Advances in the Pharmaceutical Sciences Series ◽

10.1007/978-1-4939-2316-8_11 ◽

2015 ◽

pp. 211-236

Author(s):

Feroz Jameel ◽

Sonja Wolfrum

Keyword(s):

Scale Up ◽

Mixing Processes

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Development of Drug Product Formulations: Molecular Design and Early Candidates Screening

Quality by Design for Biopharmaceutical Drug Product Development - AAPS Advances in the Pharmaceutical Sciences Series ◽

10.1007/978-1-4939-2316-8_5 ◽

2015 ◽

pp. 61-85 ◽

Cited By ~ 3

Author(s):

Michael Siedler ◽

Vineet Kumar ◽

Ravi Chari ◽

Sonal Saluja ◽

Wolfgang Fraunhofer

Keyword(s):

Molecular Design ◽

Drug Product

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Product Homogeneity Assessment During Validation of Biopharmaceutical Drug Product Manufacturing Processes

Quality by Design for Biopharmaceutical Drug Product Development - AAPS Advances in the Pharmaceutical Sciences Series ◽

10.1007/978-1-4939-2316-8_26 ◽

2015 ◽

pp. 649-659 ◽

Cited By ~ 1

Author(s):

Fuat Doymaz ◽

Frank Ye ◽

Richard K. Burdick

Keyword(s):

Drug Product ◽

Manufacturing Processes ◽

Homogeneity Assessment ◽

Product Manufacturing ◽

Product Homogeneity

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Lyophilization Process Design and Development Using QbD Principles

Quality by Design for Biopharmaceutical Drug Product Development - AAPS Advances in the Pharmaceutical Sciences Series ◽

10.1007/978-1-4939-2316-8_14 ◽

2015 ◽

pp. 303-329 ◽

Cited By ~ 1

Author(s):

Sajal M. Patel ◽

Feroz Jameel ◽

Samir U. Sane ◽

Madhav Kamat

Keyword(s):

Process Design ◽

Design And Development

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Quality by Design for Biopharmaceutical Drug Product Development - AAPS Advances in the Pharmaceutical Sciences SeriesLatest Publications

TOTAL DOCUMENTS

H-INDEX

Published By Springer New York

Regulatory Considerations for Implementation of the QbD Paradigm for Biologics: Laying the Foundation for Product and Process Lifecycle Management

Quality by Design for Distribution of Environmentally Sensitive Pharmaceutical Products

Application of Multivariate Statistical Process Monitoring to Lyophilization Process

Application of QbD Elements in the Development and Scale-up of Commercial Filling Process

Quality by Design for Primary Container Components

Quality by Design as Applied to Drug Substance Formulation Using Ultrafiltration and Diafiltration

A QbD Approach in the Development and Scale-Up of Mixing Processes

Development of Drug Product Formulations: Molecular Design and Early Candidates Screening

Product Homogeneity Assessment During Validation of Biopharmaceutical Drug Product Manufacturing Processes

Lyophilization Process Design and Development Using QbD Principles

Quality by Design for Biopharmaceutical Drug Product Development - AAPS Advances in the Pharmaceutical Sciences Series
Latest Publications