//]]>

Sterile Product Development (Record no. 17701)

000 -LEADER
fixed length control field 04420nam a22004455i 4500
003 - CONTROL NUMBER IDENTIFIER
control field OSt
005 - DATE AND TIME OF LATEST TRANSACTION
control field 20140310150238.0
007 - PHYSICAL DESCRIPTION FIXED FIELD--GENERAL INFORMATION
fixed length control field cr nn 008mamaa
008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION
fixed length control field 131012s2013 xxu| s |||| 0|eng d
020 ## - INTERNATIONAL STANDARD BOOK NUMBER
International Standard Book Number 9781461479789
978-1-4614-7978-9
050 #4 - LIBRARY OF CONGRESS CALL NUMBER
Classification number RS380
Classification number RS190-210
082 04 - DEWEY DECIMAL CLASSIFICATION NUMBER
Classification number 615.19
Edition number 23
264 #1 -
-- New York, NY :
-- Springer New York :
-- Imprint: Springer,
-- 2013.
912 ## -
-- ZDB-2-SBL
100 1# - MAIN ENTRY--PERSONAL NAME
Personal name Kolhe, Parag.
Relator term editor.
245 10 - IMMEDIATE SOURCE OF ACQUISITION NOTE
Title Sterile Product Development
Medium [electronic resource] :
Remainder of title Formulation, Process, Quality and Regulatory Considerations /
Statement of responsibility, etc edited by Parag Kolhe, Mrinal Shah, Nitin Rathore.
300 ## - PHYSICAL DESCRIPTION
Extent XVI, 585 p. 89 illus., 67 illus. in color.
Other physical details online resource.
440 1# - SERIES STATEMENT/ADDED ENTRY--TITLE
Title AAPS Advances in the Pharmaceutical Sciences Series,
International Standard Serial Number 2210-7371 ;
Volume number/sequential designation 6
505 0# - FORMATTED CONTENTS NOTE
Formatted contents note Basic Principles of Sterile Product Formulation Development -- Molecule and Manufacturability Assessment Leading to Robust Commercial Formulation for Therapeutic Proteins -- Polymer and Lipid Based Systems for Parenteral Drug Delivery -- Formulation Approaches and Strategies for PEGylated Biotherapeutics -- Nasal Delivery -- Formulation Approaches and Strategies for Vaccines and Adjuvants -- Challenges in Freeze-Thaw Processing of Bulk Protein Solutions -- Best Practices for Technology Transfer of Sterile Products: Case Studies -- Transfer Across Barrier Systems: A New Source of Simplification in Aseptic Fill and Finish Operations -- Challenges and Innovation in Aseptic Filling: Case Study with the Closed Vial Technology -- Contemporary Approaches to Development and Manufacturing of Lyophilized Parenterals -- Advances in Container Closure Integrity Testing -- Pen and Autoinjector Drug Delivery Devices -- Particulate Matter in Sterile Parenteral Products -- Appearance Evaluation of Parenteral Pharmaceutical Products -- Sterile Filtration Principles, Best Practices and New Developments -- Intravenous Admixture Compatibility for Sterile Products: Challenges and Regulatory Guidance -- Basics of Sterilization Methods -- Avoiding Common Errors during Viable Microbial Contamination Investigations -- Validation of Rapid Microbiology Methods (RMMs) -- Validation of Moist and Dry Heat Sterilization.
520 ## - SUMMARY, ETC.
Summary, etc This comprehensive book encompasses various facets of sterile product development. Key concepts relevant to the successful development of sterile products are illustrated through case studies and are covered under three sections in this book: • Formulation approaches that discuss a variety of dosage forms including protein therapeutics, lipid-based controlled delivery systems, PEGylated biotherapeutics, nasal dosage form, and vaccines • Process, container closure and delivery considerations including freeze-thaw process challenges, best practices for technology transfer to enable commercial product development, innovations and advancement in aseptic fill-finish operations, approaches to manufacturing lyophilized parenteral products, pen / auto-injector delivery devices, and associated container closure integrity testing hurdles for sterile product closures • Regulatory and quality aspects in the areas of particulate matter and appearance evaluation, sterile filtration, admixture compatibility considerations, sterilization process considerations, microbial contamination investigations and validation of rapid microbiological methods, and dry and moist heat sterilizers This book is a useful resource to scientists and researchers in both industry and academia, and it gives process and product development engineers insight into current industry practices and evolving regulatory expectations for sterile product development.
650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name as entry element Medicine.
Topical term or geographic name as entry element Pharmaceutical technology.
Topical term or geographic name as entry element Biomedicine.
Topical term or geographic name as entry element Pharmaceutical Sciences/Technology.
Topical term or geographic name as entry element Biomedicine general.
700 1# - ADDED ENTRY--PERSONAL NAME
Personal name Shah, Mrinal.
Relator term editor.
Personal name Rathore, Nitin.
Relator term editor.
710 2# - ADDED ENTRY--CORPORATE NAME
Corporate name or jurisdiction name as entry element SpringerLink (Online service)
773 0# - HOST ITEM ENTRY
Title Springer eBooks
776 08 - ADDITIONAL PHYSICAL FORM ENTRY
Display text Printed edition:
International Standard Book Number 9781461479772
856 40 - ELECTRONIC LOCATION AND ACCESS
Uniform Resource Identifier http://dx.doi.org/10.1007/978-1-4614-7978-9
942 ## - ADDED ENTRY ELEMENTS (KOHA)
Source of classification or shelving scheme
Item type E-Book
Copies
Price effective from Permanent location Date last seen Not for loan Date acquired Source of classification or shelving scheme Koha item type Damaged status Lost status Withdrawn status Current location Full call number
2014-04-05AUM Main Library2014-04-05 2014-04-05 E-Book   AUM Main Library615.19