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Sterile Product Development

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Cover of 'Sterile Product Development'

Table of Contents

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    Book Overview
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    Chapter 1 Basic Principles of Sterile Product Formulation Development
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    Chapter 2 Molecule and Manufacturability Assessment Leading to Robust Commercial Formulation for Therapeutic Proteins
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    Chapter 3 Polymer- and Lipid-Based Systems for Parenteral Drug Delivery
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    Chapter 4 Formulation Approaches and Strategies for PEGylated Biotherapeutics
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    Chapter 5 Considerations for the Development of Nasal Dosage Forms
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    Chapter 6 Formulation Approaches and Strategies for Vaccines and Adjuvants
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    Chapter 7 Challenges in Freeze–Thaw Processing of Bulk Protein Solutions
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    Chapter 8 Best Practices for Technology Transfer of Sterile Products: Case Studies
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    Chapter 9 Transfer Across Barrier Systems: A New Source of Simplification in Aseptic Fill and Finish Operations
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    Chapter 10 Challenges and Innovation in Aseptic Filling: Case Study with the Closed Vial Technology
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    Chapter 11 Contemporary Approaches to Development and Manufacturing of Lyophilized Parenterals
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    Chapter 12 Advances in Container Closure Integrity Testing
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    Chapter 13 Pen and Autoinjector Drug Delivery Devices
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    Chapter 14 Particulate Matter in Sterile Parenteral Products
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    Chapter 15 Appearance Evaluation of Parenteral Pharmaceutical Products
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    Chapter 16 Sterile Filtration: Principles, Best Practices and New Developments
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    Chapter 17 Intravenous Admixture Compatibility for Sterile Products: Challenges and Regulatory Guidance
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    Chapter 18 Basics of Sterilization Methods
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    Chapter 19 Avoiding Common Errors During Viable Microbial Contamination Investigations
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    Chapter 20 Validation of Rapid Microbiological Methods (RMMs)
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    Chapter 21 Validation of Moist and Dry Heat Sterilization
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Sterile Product Development
Published by
Springer New York, October 2013
DOI 10.1007/978-1-4614-7978-9
978-1-4614-7977-2, 978-1-4614-7978-9

Kolhe, Parag, Shah, Mrinal, Rathore, Nitin

Twitter Demographics

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Mendeley readers

The data shown below were compiled from readership statistics for 79 Mendeley readers of this research output. Click here to see the associated Mendeley record.

Geographical breakdown

Country Count As %
Unknown 79 100%

Demographic breakdown

Readers by professional status Count As %
Student > Ph. D. Student 9 11%
Researcher 7 9%
Student > Bachelor 5 6%
Student > Master 5 6%
Lecturer > Senior Lecturer 1 1%
Other 3 4%
Unknown 49 62%
Readers by discipline Count As %
Biochemistry, Genetics and Molecular Biology 6 8%
Environmental Science 4 5%
Agricultural and Biological Sciences 4 5%
Neuroscience 3 4%
Engineering 2 3%
Other 9 11%
Unknown 51 65%