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  • 1
    UID:
    almahu_9949709244702882
    Format: XXV, 682 p. 259 illus., 245 illus. in color. , online resource.
    Edition: 6th ed. 2024.
    ISBN: 9783031300233
    Content: This introductory text explains both the basic science, production, quality, dosage forms, administration, economic and regulatory aspects and the clinical applications of biotechnology-derived pharmaceuticals. It serves as a complete one-stop source for undergraduate/graduate pharmacists and pharmaceutical science students. An additional important audience are pharmaceutical scientists in industry and academia, particularly those who have not received formal training in pharmaceutical biotechnology and are inexperienced in this field. The rapid growth and advances in the field made it necessary to revise this textbook in order to continue providing up-to-date information and introduce readers to cutting edge knowledge and technology of this field. This Sixth Edition completely updates the previous edition and includes additional coverage on new approaches such as oligonucleotides, siRNA, mRNA, gene therapy, cell therapies, monoclonal antibodies and vaccines. With more than 3-million-chapter downloads, the fifth edition of the textbook has achieved widespread distribution as a key educational resource for the field of pharmaceutical biotechnology.
    Note: Molecular Biotechnology -- Biophysical and biochemical analysis of recombinant proteins -- Production and downstream processing of biotech products -- Formulation of biotech products, including biopharmaceutical considerations -- Pharmacokinetics and pharmacodynamics of peptide and protein drugs -- Immunogenicity of pharmaceutical proteins -- General considerations of monoclonal antibodies from structure to therapeutic application -- Genomics, Other "Omics" Technologies, Personalized Medicine and Additional Biotechnology-Related Techniques -- Dispensing biotechnology products: handling, professional education and product information -- Economic considerations in medical biotechnology -- Regulatory framework for biosimilars -- Vaccines -- Oligonucleotides and siRNA -- Gene therapy -- Stem cell technology -- Therapeutic Applications.-Endocrinology -- Insulin -- Follicle-stimulating hormone -- Growth hormone -- Cardiovascular and Respiratory Applications -- Recombinant coagulation factors and thrombolytics -- Recombinant human deoxyribonuclease -- Oncology -- Monoclonal antibodies in oncology -- Hematopoetic growth factors -- Inflammation and Immunemodulation -- Monoclonal antibodies in transplantation -- Monoclonal antibodies and antibody-based therapeutics in anti-inflammatory therapy -- Interferons and interleukins -- Anti-infectious diseases -- Monoclonal antibodies -- Enzyme replacement therapy.
    In: Springer Nature eBook
    Additional Edition: Printed edition: ISBN 9783031300226
    Additional Edition: Printed edition: ISBN 9783031300240
    Additional Edition: Printed edition: ISBN 9783031303272
    Language: English
    URL: Volltext  (URL des Erstveröffentlichers)
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  • 2
    UID:
    almahu_BV045860739
    Format: 1 Online-Ressource (xxiii, 653 Seiten).
    Edition: Fifth edition
    ISBN: 978-3-030-00710-2
    Additional Edition: Erscheint auch als Druck-Ausgabe ISBN 978-3-030-00709-6
    Additional Edition: Erscheint auch als Druck-Ausgabe ISBN 978-3-030-00711-9
    Language: English
    Subjects: Chemistry/Pharmacy
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    Keywords: Pharmazeutische Technologie ; Biotechnologie ; Aufsatzsammlung ; Aufsatzsammlung
    URL: Volltext  (URL des Erstveröffentlichers)
    URL: Volltext  (URL des Erstveröffentlichers)
    Author information: Meibohm, Bernd.
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  • 3
    UID:
    almafu_9959090547802883
    Format: 1 online resource (XXIII, 653 p. 246 illus., 227 illus. in color.)
    Edition: 5th ed. 2019.
    ISBN: 3-030-00710-3
    Content: This introductory text explains both the basic science and the applications of biotechnology derived pharmaceuticals, with special emphasis on their clinical use. It serves as a complete one-stop source for undergraduate/graduate pharmacists, pharmaceutical science students, and for those who did not receive formal training in this field. Pharmaceutical Biotechnology: Fundamentals and Applications, Fifth Edition completely updates the previous edition, and includes additional coverage on newer approaches such as oligonucleotides, mi/siRNA, gene therapy and advanced therapeutics. Daan J.A. Crommelin is Professor Emeritus Department of Pharmaceutical Sciences, Utrecht Institute for Pharmaceutical Sciences at Utrecht University, Utrecht, The Netherlands and Adjunct Professor in the Department of Pharmaceutics and Pharmaceutical Chemistry at the University of Utah, Salt Lake City, UT, USA Robert D. Sindelar is Professor and former Dean Faculty of Pharmaceutical Sciences and The Centre for Health Evaluation & Outcomes Sciences (CHEOS), The University of British Columbia (UBC), Vancouver, BC, Canada and President of the Global Drug Commercialization Centre (GDCC)-China and Vice-President GDCC-worldwide, Chengdu, China Bernd Meibohm is Professor of Pharmaceutical Sciences and Associate Dean for Research and Graduate Programs at the University of Tennessee Health Science Center, College of Pharmacy, Memphis, TN, USA.
    Note: Molecular Biotechnology -- Biophysical and biochemical analysis of recombinant proteins -- Production and downstream processing of biotech products -- Formulation of biotech products, including biopharmaceutical considerations -- Pharmacokinetics and pharmacodynamics of peptide and protein drugs -- Immunogenicity of pharmaceutical proteins -- General considerations of monoclonal antibodies from structure to therapeutic application -- Genomics, Other “Omics” Technologies, Personalized Medicine and Additional Biotechnology-Related Techniques -- Dispensing biotechnology products: handling, professional education and product information -- Economic considerations in medical biotechnology -- Regulatory framework for biosimilars -- Vaccines -- Oligonucleotides and siRNA -- Gene therapy -- Stem cell technology -- Therapeutic Applications.-Endocrinology -- Insulin -- Follicle-stimulating hormone -- Growth hormone -- Cardiovascular and Respiratory Applications -- Recombinant coagulation factors and thrombolytics -- Recombinant human deoxyribonuclease -- Oncology -- Monoclonal antibodies in oncology -- Hematopoetic growth factors -- Inflammation and Immunemodulation -- Monoclonal antibodies in transplantation -- Monoclonal antibodies and antibody-based therapeutics in anti-inflammatory therapy -- Interferons and interleukins -- Anti-infectious diseases -- Monoclonal antibodies -- Enzyme replacement therapy.
    Additional Edition: ISBN 3-030-00709-X
    Language: English
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  • 4
    UID:
    almafu_9959328632602883
    Format: 1 online resource (xxi, 403 pages) : , illustrations
    ISBN: 9783527609628 , 3527609628 , 9783527609529 , 3527609520
    Content: This first ever coverage of the pharmacokinetic and pharmacodynamic characteristics of biopharmaceuticals meets the need for a comprehensive book in this field. It spans all topics from lead identification right up to final-stage clinical trials. Following an introduction to the role of PK and PD in the development of biotech drugs, the book goes on to cover the basics, including the pharmacokinetics of peptides, monoclonal antibodies, antisense oligonucleotides, as well as viral and non-viral gene delivery vectors. The second section discusses such challenges and opportunities as pulmonary de.
    Note: The role of pharmacokinetics and pharmacodynamics in the development of biotech drugs / Bernd Meibohm -- Pharmacokinetics of peptides and proteins / Lisa Tang, Bernd Meibohm -- Pharmacokinetics of monoclonal antibodies / Katharina Kuester, Charlotte Kloft -- Pharmacokinetics and pharmacodynamics of antisense oligonucleotides / Rosie Z. Yu, Richard S. Geary, Arthur A. Levin -- Pharmacokinetics of viral and non-viral gene delivery vectors / Martin Meyer, Gururaj Rao, Ke Ren, Jeffrey Hughes -- Bioanalytical methods used for pharmacokinetic evaluations of biotech macromolecule drugs : issues, assay approaches, and limitations / Jean W. Lee -- Limitations of noncompartmental pharmacokinetic analysis of biotech drugs / Arthur B. Straughn -- Bioequivalence of biologics / Jeffrey S. Barrett -- Biopharmaceutical challenges: pulmonary delivery of proteins and peptides / Kun Cheng, Ram I. Mahato -- Biopharmaceutical challenges : delivery of oligonucleotides / Lloyd G. Tillman, Gregory E. Hardee -- Custom-tailored pharmacokinetics and pharmacodynamics via chemical modifications of biotech drugs / Francesco M. Veronese, Paolo Caliceti -- Exposure-response relationships for therapeutic biologic products / Mohammad Tabrizi, Lorin K. Roskos -- Preclinical and clinical drug development of tasidotin, a depsi-pentapeptide oncolytic agent / Peter L. Bonate, Larry Arthaud, Katherine Stephenson -- Clinical drug development of cetuximab, a monoclonal antibody / Arno Nolting, Floyd E. Fox, Andreas Kovar -- Integration of pharmacokinetics and pharmacodynamics into the drug development of pegfilgrastim, a pegylated protein / Bing-Bing Yang.
    Additional Edition: Print version: Pharmacokinetics and pharmacodynamics of biotech drugs. Weinheim, Germany : Wiley-VCH, ©2006 ISBN 3527314083
    Additional Edition: ISBN 9783527314089
    Language: English
    Keywords: Electronic books. ; Electronic books. ; Electronic books.
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  • 5
    UID:
    almafu_BV010174636
    Format: IV, 125 S. : graph. Darst.
    Note: Braunschweig, Techn. Univ., Diss., 1994
    Language: German
    Keywords: Mexiletin ; Stereoselektivität ; Pharmakokinetik ; Hochschulschrift
    Author information: Meibohm, Bernd
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  • 6
    UID:
    gbv_1691371513
    Format: 1 Online-Ressource (xvii, 171 Seiten, 9431 KB) , Illustrationen, Diagramme
    Content: Monoclonal antibodies (mAbs) are an innovative group of drugs with increasing clinical importance in oncology, combining high specificity with generally low toxicity. There are, however, numerous challenges associated with the development of mAbs as therapeutics. Mechanistic understanding of factors that govern the pharmacokinetics (PK) of mAbs is critical for drug development and the optimisation of effective therapies; in particular, adequate dosing strategies can improve patient quality life and lower drug cost. Physiologically-based PK (PBPK) models offer a physiological and mechanistic framework, which is of advantage in the context of animal to human extrapolation. Unlike for small molecule drugs, however, there is no consensus on how to model mAb disposition in a PBPK context. Current PBPK models for mAb PK hugely vary in their representation of physiology and parameterisation. Their complexity poses a challenge for their applications, e.g., translating knowledge from animal species to humans. In this thesis, we developed ...
    Note: Dissertation Universität Potsdam 2018
    Additional Edition: Erscheint auch als Druck-Ausgabe Fuhrmann, Saskia Physiologically-based pharmacokinetic and mechanism-based pharmacodynamic modelling of monoclonal antibodies with a focus on tumour targeting Potsdam, 2018
    Language: English
    Keywords: Hochschulschrift
    Author information: Meibohm, Bernd
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  • 7
    UID:
    b3kat_BV010174636
    Format: IV, 125 S. , graph. Darst.
    Note: Braunschweig, Techn. Univ., Diss., 1994
    Language: German
    Keywords: Mexiletin ; Stereoselektivität ; Pharmakokinetik ; Hochschulschrift
    Author information: Meibohm, Bernd
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  • 8
    UID:
    almahu_BV046722606
    Format: XXIII, 653 Seiten : , Illustrationen ; , 27.9 cm x 21 cm.
    Edition: Fifth edition
    ISBN: 978-3-030-00709-6 , 3-030-00709-X
    Additional Edition: Erscheint auch als Online-Ausgabe ISBN 978-3-030-00710-2
    Former: Vorangegangen ist
    Language: English
    Subjects: Chemistry/Pharmacy
    RVK:
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    Keywords: Pharmazeutische Technologie ; Biotechnologie ; Aufsatzsammlung
    Author information: Meibohm, Bernd.
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  • 9
    UID:
    almahu_BV010174636
    Format: IV, 125 S. : graph. Darst.
    Note: Braunschweig, Techn. Univ., Diss., 1994
    Language: German
    Keywords: Mexiletin ; Stereoselektivität ; Pharmakokinetik ; Hochschulschrift
    Author information: Meibohm, Bernd.
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  • 10
    Online Resource
    Online Resource
    Hoboken, N.J. :John Wiley & Sons,
    UID:
    almahu_9948318425202882
    Format: xv, 361 p. : , ill.
    Edition: Electronic reproduction. Ann Arbor, MI : ProQuest, 2016. Available via World Wide Web. Access may be limited to ProQuest affiliated libraries.
    Note: Drug interactions for therapeutic proteins : a journey just beginning / Honghui Zhou, Bernd Meibohm -- Pharmacokinetic and pharmacodynamic-based drug interactions for therapeutic proteins / Dan Lu ... [et al.] -- Drug interaction assessment strategies : small molecules versus therapeutic proteins / Shannon Dallas ... [et al.] -- Model-independent and modeling-based methods to assess drug-drug interactions for therapeutic proteins / Di Wu, Jeffrey Barrett -- Utility of in vitro methods in drug-drug interaction assessment and prediction for therapeutic biologics / Theresa Nguyen, Narendra Kishnani, Raymond Evers -- Use of animal models for projection of clinical drug-drug interactions for therapeutic proteins / Eugenia Kraynov, Martin E. Dowty -- The "cocktail" approach and its utility in drug-drug interaction assessments for therapeutic proteins / Alexander Jetter, Uwe Fuhr -- Logistic considerations in study design for biologic drug-drug interaction assessments / Min Zhu and Yu-Nien (Tom) Sun -- Statistical considerations in assessing drug-drug interactions for therapeutic proteins / Chuanpu Hu and Honghui Zhou -- FDA perspectives on therapeutic protein drug-drug interaction assessments / Hong Zhao ... [et al.] -- Disease-drug-drug interaction assessments for tocilizumab : a monoclonal antibody against interleukin-6 receptor to treat patients with rheumatoid arthritis / Xuapang Zhang and Barbara J. Brennan -- -- Drug-drug interactions for etamercept : a fusion protein / Joan Korth-Bradley -- Drug interactions of cytokines and anti-cytokine therapeutic proteins / J. Greg Slatter L.C. Wienkers and Leslie J. Dickmann -- Drug interactions for growth factors and hormones / Yow-Ming Wang, Tarundeep Kakkar -- Drug-drug interactions for nucleic acid-based derivatires / Jan Wang and Hong Zhao.
    Language: English
    Keywords: Electronic books.
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