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Pharmaceutical dosage forms. Parenteral medications : Volume 3: Regulations, validation and the future / edited by Sandeep Nema, John D. Ludwig.

Contributor(s): Material type: TextTextSeries: ; V-3Publication details: London : Informa healthcare, 2010Edition: 3rd edDescription: xiv, 304 p. : tables, ill. figs, picture. ; 26 cmISBN:
  • 9781420086539
  • 9781420086478
Subject(s): DDC classification:
  • 615.19 NEP
Contents:
Chapter 1 cGMP regulations of parenteral drugs
Chapter 2 Risk assessment and mitigation in aseptic processing
Chapter 3 Development challenges and validation of fill and finish processes for biotherapeutics;
Chapter 4 Visual inspection;
Chapter 5 Advances in parenteral injection devices and aids;
Chapter 6 siRNA targeting using injectable nano-based delivery systems;
Chapter 7 Excipients for parenteral dosage forms: regulatory considerations and controls;
Chapter 8 Techniques to evaluate damage and pain on injection.
Chapter 9 Parenteral product specifications and stability
Chapter 10 The management of extractables and leachables in pharmaceutical products;
Chapter 11 Process analytical technology and rapid microbiological methods;
Chapter 12 Quality assurance;
Chapter 13 Application of Quality by Design in CMCa development;
Chapter 14 Future of parenteral manufacturing;
Summary: Summary:This three-volume set of Pharmaceutical Dosage Forms: Parenteral Medications is an authoritative, comprehensive reference work on the formulation and manufacture of parenteral dosage forms, effectively balancing theoretical considerations with the practical aspects of their development
Item type: Books
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Holdings
Item type Current library Collection Shelving location Call number Copy number Status Date due Barcode
Books Books KU Central Library Rack No. : 27 Shelve No. : B-01 Reference Section (Non-Issuable Books) 615.19 NEP (Browse shelf(Opens below)) 3/3 Not For Loan 36012
Books Books KU Central Library Rack No. : 63 Shelve No. : A-03 General Stack (Issuable Books) 615.19 NEP 2010 (Browse shelf(Opens below)) C-3 (I) Available 51519
Books Books KU Central Library Rack No. : 63 Shelve No. : A-03 General Stack (Issuable Books) 615.19 NEP 2010 (Browse shelf(Opens below)) C-4 (I) Available 51520
Books Books KU Central Library Rack No. : 63 Shelve No. : A-03 General Stack (Issuable Books) 615.19 NEP 2010 (Browse shelf(Opens below)) C-5 (I) Available 53840
Books Books KU Central Library Rack No. : 27 Shelve No. : B-03 Reference Section (Non-Issuable Books) 615.19 NEP 2010 (Browse shelf(Opens below)) C-2 (NI) Not For Loan 51518

Includes bibliographical references and index.

Chapter 1 cGMP regulations of parenteral drugs

Chapter 2 Risk assessment and mitigation in aseptic processing

Chapter 3 Development challenges and validation of fill and finish processes for biotherapeutics;

Chapter 4 Visual inspection;

Chapter 5 Advances in parenteral injection devices and aids;

Chapter 6 siRNA targeting using injectable nano-based delivery systems;

Chapter 7 Excipients for parenteral dosage forms: regulatory considerations and controls;

Chapter 8 Techniques to evaluate damage and pain on injection.

Chapter 9 Parenteral product specifications and stability

Chapter 10 The management of extractables and leachables in pharmaceutical products;

Chapter 11 Process analytical technology and rapid microbiological methods;

Chapter 12 Quality assurance;

Chapter 13 Application of Quality by Design in CMCa development;

Chapter 14 Future of parenteral manufacturing;

Summary:This three-volume set of Pharmaceutical Dosage Forms: Parenteral Medications is an authoritative, comprehensive reference work on the formulation and manufacture of parenteral dosage forms, effectively balancing theoretical considerations with the practical aspects of their development

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