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The Omega Connection
Published by Esquire Books, 1916
ISBN 10: 0961784105ISBN 13: 9780961784102
Book
Condition: Good. Former library book; may include library markings. Used book that is in clean, average condition without any missing pages.
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Textbook of Biopharmaceutics and Clinical Pharmacokinetics
Published by Appleton & Lange, 1979
ISBN 10: 0838588689ISBN 13: 9780838588680
Book
Condition: Good. Used book that is in clean, average condition without any missing pages.
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Used offers from US$ 4.80
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Hardcover. Condition: Used; Very Good. Dispatched, from the UK, within 48 hours of ordering. Though second-hand, the book is still in very good shape. Minimal signs of usage may include very minor creasing on the cover or on the spine.
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Handbook of Preformulation: Chemical, Biological, and Botanical Drugs
Published by Informa Healthcare, 2006
ISBN 10: 0849371937ISBN 13: 9780849371936
Book
Hardcover. Condition: LIKE NEW. Like new, very light shelf wear.
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Filing Patents Online : A Professional Guide
Published by Taylor & Francis Group, 2003
ISBN 10: 0849316243ISBN 13: 9780849316241
Book First Edition
Condition: Good. 1st Edition. Former library book; may include library markings. Used book that is in clean, average condition without any missing pages.
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International EditionCondition: New. Brand New Paperback International Edition.We Ship to PO BOX Address also. EXPEDITED shipping option also available for faster delivery.This item may ship from the US or other locations in India depending on your location and availability.
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Condition: New.
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Wine of Passion - The Urdu Ghazals of Ghalib
Published by Ferozsons (Pvt) Ltd., 2009
ISBN 10: 0971474613ISBN 13: 9780971474611
Book
Hardcover. Condition: GOOD. Spine creases, wear to binding and pages from reading. May contain limited notes, underlining or highlighting that does affect the text. Possible ex library copy, will have the markings and stickers associated from the library. Accessories such as CD, codes, toys, may not be included.
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Handbook of Pharmaceutical Manufacturing Formulations. Volume 5 Over-the-Counter Products
Published by CRC Press 2019-09-23, Boca Raton, 2019
ISBN 10: 0367385201ISBN 13: 9780367385200
Book
paperback. Condition: New. Language: ENG.
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Condition: Very Good. Very Good condition. Published by Appleton-Century-Crofts. Stamped on front endpage. (pharmacology, medicine, medical).
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Handbook of Biogeneric Therapeutic Proteins: Regulatory, Manufacturing, Testing, and Patent Issues
Published by Taylor & Francis Inc, United States, Bosa Roca, 2002
ISBN 10: 0849329914ISBN 13: 9780849329913
Book
Paperback. Condition: Very Good. More than 20 billion dollars worth of biopharmaceuticals are scheduled to go off-patent by 2006. Given the strong political impetus and the development of technological tools that can answer the questions regulatory authorities may raise, it is inevitable that the FDA and EMEA will allow biogeneric or biosimilar products. Even with all the regulatory wrinkles yet to be ironed out, generic or similar biological products are soon to become a reality. Handbook of Biogeneric Therapeutic Proteins is the first book to review and analyze the status of biotechnology, regulatory environment, manufacturing methodologies, testing requirements and intellectual property issues. The book provides complete and thorough coverage of the regulatory and technological challenges of developing generic therapeutic proteins and how to prepare detailed regulatory and manufacturing plans and policies. The author includes information on establishing a manufacturing system, securing regulatory approval, and setting up facilities to manufacture raw materials and prepare finished products. He also supplies details about the Chemistry, Manufacturing, and Controls (CMC) section of the FDA's New Drug Application for Biological Products. In brief, the book supplies everything a manufacturer would need to plan the development of biogeneric products and complete the process of regulatory filing. Waiting for the FDA to issue guidelines is a mistake. The scramble to catch up could leave your company way behind in the game. Your organization needs to begin developing and characterizing genetically modified cells now and to complete initial GMP production runs through a CRO to get ready for the newer testing the FDA might impose. Packed with tables and figures that provide speedy access to precise, timely data, including full formulation details on all FDA approved biological product, this book contains a broad range of resource materials about suppliers, manufacturers, and testing faciliti. The book has been read, but is in excellent condition. Pages are intact and not marred by notes or highlighting. The spine remains undamaged.
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Condition: VG. NY 1979 Appleton. 8vo., 332pp., hardcover. VG, no DJ.
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Handbook of Preformulation
Published by CRC Press 2022-06-13, Boca Raton, 2022
ISBN 10: 1032338474ISBN 13: 9781032338477
Book
paperback. Condition: New. Language: ENG.
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International Edition
Handbook Of Bioequivalence Testing, Dpss. 171
Published by Informa Healthcare, 2007
Condition: Brand New. New. SoftCover International edition. Different ISBN and Cover image but contents are same as US edition. Excellent Customer Service.
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International Edition
Condition: Brand New. New. SoftCover International edition. Different ISBN and Cover image but contents are same as US edition. Excellent Customer Service.
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International Edition
Condition: Brand New. New. SoftCover International edition. Different ISBN and Cover image but contents are same as US edition. Excellent Customer Service.
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Handbook of Biogeneric Therapeutic Proteins: Regulatory, Manufacturing, Testing, and Patent Issues
Published by CRC Press 2019-12-09, Boca Raton, 2019
ISBN 10: 0367454815ISBN 13: 9780367454814
Book
paperback. Condition: New. Language: ENG.
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International Edition
Condition: Brand New. New. SoftCover International edition. Excellent Customer Service.
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Fundamentals of Modern Bioprocessing
Published by CRC Press 2017-07-27, Boca Raton, 2017
ISBN 10: 1138893293ISBN 13: 9781138893290
Book
paperback. Condition: New. Language: ENG.
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Handbook of Pharmaceutical Manufacturing Formulations. Volume Two Uncompressed Solid Products
Published by CRC Press 2019-09-23, Boca Raton, 2019
ISBN 10: 036738521XISBN 13: 9780367385217
Book
paperback. Condition: New. Language: ENG.
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International Edition
HANDBOOK OF PHARMACEUTICAL MANUFACTURING, 2ND EDITION, VOLUME. 3: LIQUID PRODUCTS (ORIGINAL PRICE £ 127.00)
Published by Informa Healthcare, 2009
Condition: Brand New. New. SoftCover International edition. Different ISBN and Cover image but contents are same as US edition. Excellent Customer Service.
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Handbook of Pharmaceutical Manufacturing Formulations: Volume Three, Liquid Products
Published by CRC Press 2018-02-26, Boca Raton, 2018
ISBN 10: 1138113794ISBN 13: 9781138113794
Book
paperback. Condition: New. Language: ENG.
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Disposable Bioprocessing Systems
Published by CRC Press 2017-04-21, Boca Raton, 2017
ISBN 10: 1138077003ISBN 13: 9781138077003
Book
paperback. Condition: New. Language: ENG.
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International Edition
Condition: Brand New. New. SoftCover International edition. Excellent Customer Service.
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Biosimilars and Interchangeable Biologics. Strategic Elements
Published by CRC Press 2017-07-27, Boca Raton, 2017
ISBN 10: 1138775509ISBN 13: 9781138775503
Book
paperback. Condition: New. Language: ENG.
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Handbook of Pharmaceutical Manufacturing Formulations - 6 Volume Set: Handbook of Pharmaceutical Manufacturing Formulations: Uncompressed Solid Products (Volume 2 of 6)
Published by CRC Press, 2004
ISBN 10: 0849317479ISBN 13: 9780849317477
Book
Hardcover. Condition: Used; Very Good. Dispatched, from the UK, within 48 hours of ordering. Though second-hand, the book is still in very good shape. Minimal signs of usage may include very minor creasing on the cover or on the spine.
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Used offers from US$ 100.09
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Disposable Bioprocessing Systems
Published by CRC Press, 2012
ISBN 10: 1439866708ISBN 13: 9781439866702
Book First Edition
Hardcover. Condition: Very Good. 1st Edition. Hardcover, xxi + 300 pages, NOT ex-library. Printed in the USA. Minor handling wear. Book is clean and bright throughout with unmarked text, free of inscriptions and stamps, firmly bound. Issued without a dust jacket. -- Contents: 1. Bioprocessing Industry: An Introduction [Summary; Complete Lines of Disposable Systems; Chromatography Columns] 2. Safety of Disposable Systems [Polymers and Additives (Material Selection; Testing); Partnering with Vendors; Responsibility of Sponsors; Regulatory Requirements (United States and Canada; Europe); Risk Assessment; Use of International Standard ISO-10993 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing'; Background; International Guidance and Standards] 3. Containers [Proprietary Bag Suppliers; Generic Bag Suppliers; Tank Liners; 2D Fluid Containers; 2D Powder Bags; 3D Bags; Transportation Container; Summary] 4. Mixing Systems [Types of Mixing; Stirring Magnetic Mixer; Stirring Mechanical Coupling Mixer; Tumbling Mixer; Oscillating Mixer; Peristaltic Mixer] 5. Disposable Bioreactors [Xcellerex Bioreactor; Cellexus Bioreactor; CELL-tainer Cell Culture System; Wave-Mixed Bioreactors; Stirred Single-Use Bioreactors; Integrity TM PadReactor TM; CellReady Bioreactor (Orbitally Shaken Single-Use Bioreactors; Bioreactor Selection); Game Changers in Disposable Bioreactor Industry; Current Literature Survey of the Use of Disposable Systems] 6. Connectors and Transfers [Tubing; Fittings and Accessories; Pumps; Aseptic Coupling; Aseptic Connectors; Welding; Aseptic Transfer Systems; Tube Sealers; Sampling; Conclusion] 7. Controls [Sampling Systems; TRACE System; Optical Sensors; Biomass Sensors; Electrochemical Sensors; Pressure Sensors] 8. Downstream Processing [Case of Monoclonal Antibodies: A GE Report; Membrane Chromatography; Virus Removal; Buffers; Fluid Management; Bioseparation; Depth Filtration; Ultrafiltration; Integrated Systems] 9. Filling and Finishing Systems [Robert Bosch Packaging Systems; PDC Aseptic Filling Systems] 10. Filtration [Dead-End Filtration; Cross-Flow Filtration; Filtration Media; Polymer Membranes; Microfiltration Cross-Flow (BioOptimal MF-SL; TechniKrom; GE Healthcare; Spectrum)] 11. Regulatory Compliance [Regulatory Barriers; Irradiation and Sterilization Validation] 12. Environmental Concerns [Biosafety; Liquid Waste; Incineration; Pyrolysis; Grind and Autoclave; Landfill; Treatment; Overall Environmental Impact; Summary; Classification of Human Etiologic Agents on the Basis of Hazard; Physical Containment for Large-Scale Uses of Organisms Containing Recombinant DNA Molecules] 13. Epilogue [Large Scale; Integrity; Flexibility; Universal Use; Scale-Up; Cost; Out of Steam; Validation; Leachables; Animal Origins; Stainless Challenge; Standardization; Upstream; Compliance; High-Expression Cell Lines; Flexible Factories; Small Companies; Unitary Systems; Biosafety; Autoclaves; SIP/CIP; Distilled Water Loops; Low Ceiling Heights; Modular Systems; Gentle Mixing; 2D Bags; Fluoropolymer Bags; Protein Capture; Downstream Processing; Closed Systems; Molecule-Specific Facilities; Max-Dispo Concept; Leachables/Extractables; Multipurpose Disposable Bioreactors]; Bibliography; Index -- Because of many misconceptions, the biological drug manufacturing industry does not fully utilize disposable components, despite their wide availability. These misconceptions include concerns for the quality of materials, running costs, scalability, the level of automation possible, and the training of staff needed to include these components in existing bioprocessing systems. Not fully realizing the long-term benefits, many manufacturers are unwilling to discard investments made in fixed equipment and traditional stainless steel systems. Regulatory and environmental concerns, however, will eventually compel manufacturers to adopt disposable systems. Making a strong case for disposables, Disposable Bioprocessing Systems demonstrates the true potential of these systems.
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Future of Pharmaceuticals : A Nonlinear Analysis
Published by CRC Press, 2022
ISBN 10: 0367701391ISBN 13: 9780367701390
Book
Condition: As New. Unread book in perfect condition.
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HANDBOOK OF BIOEQUIVALENCE TESTING, 2ND EDITION
Published by CRC Press, 2014
ISBN 10: 1482226375ISBN 13: 9781482226379
Book
Condition: Brand New. New. US edition. Expediting shipping for all USA and Europe orders excluding PO Box. Excellent Customer Service.
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Biosimilarity: The FDA Perspective
Published by CRC Press, 2018
ISBN 10: 1498750397ISBN 13: 9781498750394
Book
Condition: New. Book is in NEW condition.
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