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Pharmaceutical technology

  • 21 CFR Part 11by Orlando López

    CRC Press 2004; US$ 188.95

    Covering regulatory requirements stipulated by the FDA, this book delineates the organization, planning, verification, and documentation activities and procedural controls required for compliance. The author introduces appropriate supporting technologies such as encryption and digital signatures and places regulatory compliance within the context of... more...

  • Aqueous Polymeric Coatings for Pharmaceutical Dosage Forms, Third Editionby Linda A. Felton; James W. McGinity

    CRC Press 2008; US$ 188.95

    Latex Emulsions for Controlled Drug Delivery.  Aqueous Polymeric Coating for Modified Release Oral Dosage Forms.  Processing and Equipment Considerations for Aqueous Coatings.  Mechanical Properties of Polymeric Films Prepared from Aqueous Polymeric Dispersions.  Plasticizers and Their Application in Pharmaceutical Coatings.  Defects in Aqueous Film-Coated... more...

  • Biologics in General Medicineby W.-H. Boehncke; H.H. Radeke

    Springer Berlin Heidelberg 2007; US$ 239.00

    The idea for this book was born during the symposium on biologics organized by ZAFES (Center for Drug Research, Development and Safety at the University of Frankfurt am Main) in September 2005. Highly distinguished researchers special- ing in the field of biologics had gathered together to exchange information on this relatively new subject. Realizing... more...

  • Calibration in the Pharmaceutical Laboratoryby Tony Kowalski

    CRC Press 2001; US$ 167.95

    Introduction, T. Kowalski, Sartorius Limited The Laboratory Balance Printed Results Data Communications Via a Personal Computer Software Integrated into Balances Moisture Analyzers Calibration of Micropipettes in a Quality System Using a Balance and PC Intrinsically Safe Weighing Equipment for Hazardous Areas Commissioning of Balances Appendix 1.1:... more...

  • Clean-In-Place for Biopharmaceutical Processesby Dale A. Seiberling

    CRC Press 2007; US$ 177.95

    Introduction. Project Planning for the CIPable Pharmaceutical or Biotechnology Facility. Water for the CIP System. Cleanable Systems and Components. Cleaning Mechanisms and Agents. Cleaning Cycle Sequences. CIP Systems, Components and Design. CIP System Instrumentation and Controls. Cleaning Agent Dosing Systems. Spray Devices. CIP Distribution... more...

  • Cleaning Validation Manualby Syed Imtiaz Haider; Syed Erfan Asif

    CRC Press 2010; US$ 167.95

    CLV-1 How to Establish a Cleaning Validation Program CLV-2 Introduction CLV-3 Scope and Approach CLV-4 Cleaning Validation Team Members and Responsibilities CLV-5 Cleaning Validation Philosophy, Strategies, and Methodology CLV-6 Planning Phase CLV-7 Execution Phase CLV-8 Analytical Testing and Reporting Phase CLV-9 Equipment Description CLV-10... more...

  • Compliance Handbook for Pharmaceuticals, Medical Devices, and Biologicsby Carmen Medina

    CRC Press 2003; US$ 188.95

    Regulatory submissions, Patricia Fritz and Anisa Dhalla; compliance requirements during the drug development process, Martin D. Hynes; validation - a new perspective, James Agalloco; validating analytical methods for pharmaceutical applications - a comprehensive approach, Paul A. Winslow and Richard F. Meyer; the stability testing programme, Maria... more...

  • Comprehensive Bioactive Natural Products, 7by V.K. Gupta

    Studium Press 2010; US$ 110.00

    Nature has been providing products that have implications as pharmacological agents. There is even a traditional belief that all the plants grown on this planet have some or other therapeutic/physiological attributes. Natural products isolated in original form are often not fit for their use in human or animal medicine. Sometimes they don?t have the... more...

  • Continuous Processing in Pharmaceutical Manufacturingby Ganapathy Subramanian

    Wiley 2014; US$ 147.50

    With contributions from biotechnologists and bioengineers, this ready reference describes the state of the art in industrial biopharmaceutical production, with a strong focus on continuous processes. Recent advances in single-use technology as well as application guidelines for all types of biopharmaceutical products, from vaccines to antibodies,... more...