LEADER 05126nam 2200385 n 450 001 9910647218303321 005 20230328051353.0 010 $a3-0365-6483-7 035 $a(CKB)5680000000300165 035 $a(NjHacI)995680000000300165 035 $a(EXLCZ)995680000000300165 100 $a20230328d2023 uu 0 101 0 $aeng 135 $aur||||||||||| 181 $ctxt$2rdacontent 182 $cc$2rdamedia 183 $acr$2rdacarrier 200 00$a3D Innovations in Personalized Surgery /$fedited by Joep Kraeima, Sebastiaan de Visscher, Max J. H. Witjes 210 1$a[Place of publication not identified] :$cMDPI AG,$d2023. 215 $a1 online resource (154 pages) 311 $a3-0365-6484-5 327 $aJoep Kraeima, Sebastiaan de Visscher and Max Witjes Three-Dimensional Innovations in Personalized Surgery -- Sherif Idris, Heather Logan, Paul Tabet, Martin Osswald, Suresh Nayar and Hadi Seikaly The Accuracy of 3D Surgical Design and Simulation in Prefabricated Fibula Free Flaps for Jaw Reconstruction -- Nick Assink, Anne M. L. Meesters, Kaj ten Duis, Jorrit S. Harbers, Frank F. A. IJpma and Hugo C. van der Veen et al. A Two-Step Approach for 3D-Guided Patient-Specific Corrective Limb Osteotomies -- Anne M. L. Meesters, Miriam G. E. Oldhoff, Neeltje M. Trouwborst, Nick Assink, Joep Kraeima and Max J. H. Witjes et al. QuantitativeThree-DimensionalMeasurementsofAcetabularFractureDisplacementCouldBe Predictive for Native Hip Survivorship -- Bram B.J. Merema, Max J.H. Witjes, Nicolaas B.Van Bakelen, Joep Kraeima and Frederik K. L. Spijkervet Four-Dimensional Determination of the Patient-Specific Centre of Rotation for Total Temporomandibular Joint Replacements: Following the Groningen Principle -- Juliana F. Sabelis, Ruud Schreurs, Harald Essig, Alfred G. Becking and Leander Dubois Personalized Medicine Workflow in Post-Traumatic Orbital Reconstruction -- Bram B. J. Merema, Jelbrich J. Sieswerda, Frederik K. L. Spijkervet, Joep Kraeima and Max J. H. Witjes A Contemporary Approach to Non-Invasive 3D Determination of Individual Masticatory Muscle Forces: A Proof of Concept -- Enkh-Orchlon Batbayar, Nick Assink, Joep Kraeima, Anne M. L. Meesters, Ruud R. M. Bos and Arjan Vissink et al. Quantitative Three-Dimensional Computed Tomography Measurements Provide a Precise Diagnosis of Fractures of the Mandibular Condylar Process -- Nicolaas B. van Bakelen,Jasper W.van der Graaf, Joep Kraeima and Frederik K. L.Spijkervet Reproducibility of 2D and 3D Ramus Height Measurements in Facial Asymmetry -- Peter A. J. Pijpker, Jos M. A. Kuijlen, Katalin Tama´si, D. L. Marinus Oterdoom, Rob A. Vergeer and Gijs Rijtema et al. The Accuracy of Patient-Specific Spinal Drill Guides Is Non-Inferior to Computer-Assisted Surgery: The Results of a Split-Spine Randomized Controlled Trial -- Seung-Han Shin, Moo-Sub Kim, Do-Kun Yoon, Jae-Jin Lee and Yang-Guk Chung Does a Customized 3D Printing Plate Based on Virtual Reduction Facilitate the Restoration of Original Anatomy in Fractures? -- Haye H. Glas, Joep Kraeima, Silke Tribius, Frank K. J. Leusink, Carsten Rendenbach and Max Heiland et al. Three-Dimensional Evaluation of Isodose Radiation Volumes in Cases of Severe Mandibular Osteoradionecrosis for the Prediction of Recurrence after Segmental Resection -- Nathalie Vosselman, Haye H. Glas, Bram J. Merema, Joep Kraeima, Harry Reintsema and Gerry M. Raghoebar et al. Three-Dimensional Guided Zygomatic Implant Placement after Maxillectomy. 330 $aCurrent practice involves the use of 3D surgical planning and patient-specific solutions in multiple surgical areas of expertise. Patient-specific solutions have been endorsed for several years in numerous publications due to their associated benefits around accuracy, safety, and predictability of surgical outcome. The basis of 3D surgical planning is the use of high-quality medical images (e.g., CT, MRI, or PET-scans). The translation from 3D digital planning toward surgical applications was developed hand in hand with a rise in 3D printing applications of multiple biocompatible materials. These technical aspects of medical care require engineers' or technical physicians' expertise for optimal safe and effective implementation in daily clinical routines. The aim and scope of this Special Issue is high-tech solutions in personalized surgery, based on 3D technology and, more specifically, bone-related surgery. Full-papers or highly innovative technical notes or (systematic) reviews that relate to innovative personalized surgery are invited. This can include optimization of imaging for 3D VSP, optimization of 3D VSP workflow and its translation toward the surgical procedure, or optimization of personalized implants or devices in relation to bone surgery. 606 $aSurgery 615 0$aSurgery. 676 $a617 702 $aWitjes$b Max J. H. 702 $ade Visscher$b Sebastiaan 702 $aKraeima$b Joep 801 0$bNjHacI 801 1$bNjHacl 906 $aBOOK 912 $a9910647218303321 996 $a3D Innovations in Personalized Surgery$93012742 997 $aUNINA LEADER 06590nam 22008415 450 001 9910255266603321 005 20230810190600.0 010 $a3-319-46891-X 024 7 $a10.1007/978-3-319-46891-4 035 $a(CKB)3710000001364128 035 $a(DE-He213)978-3-319-46891-4 035 $a(MiAaPQ)EBC4855636 035 $a(PPN)222235632 035 $a(EXLCZ)993710000001364128 100 $a20170505d2017 u| 0 101 0 $aeng 135 $aurnn#---|amaa 181 $ctxt$2rdacontent 182 $cc$2rdamedia 183 $acr$2rdacarrier 200 10$aAbuse of Dominant Position and Globalization & Protection and Disclosure of Trade Secrets and Know-How /$fedited by Pranvera Këllezi, Bruce Kilpatrick, Pierre Kobel 205 $a1st ed. 2017. 210 1$aCham :$cSpringer International Publishing :$cImprint: Springer,$d2017. 215 $a1 online resource (XVIII, 637 pages) $c12 illustrations (6 in color); digital, PDF file(s) 225 1 $aLIDC Contributions on Antitrust Law, Intellectual Property and Unfair Competition,$x2199-7438 311 08$aPrint version: 9783319468907 320 $aIncludes bibliographical references. 327 $aPart I - Abuse of Dominant Position and Globalization: International Report by Pinar Akman -- Austria by Gerhard Fussenegger, Florian Schuhmacher and Rainer Tahedl -- Belgium by Pierre M. Sabbadini -- Bulgaria by Anton Petrov -- France by Mathilde Boudou, Clément Hubert, Thibaut Marcerou, Georges Poulakos, Michaël Vaz d'Almeida and Martina Isola -- Germany by Marco Hartmann-Rüppel -- Japan by Takahiko Itoh -- Lithuania by Yvonne Goldammer -- Moldova by Alexandr Svetlicinii -- Poland by Aleksander Stawicki, Bartosz Turno and Tomasz Feliszewski -- Spain by Manuel Cañadas Bouwen and Julia Suderow -- Sweden by Trine Osen Bergqvist -- Switzerland by Denis Cherpillod -- The Netherlands by Sarah Beeston and Maria Geilmann -- Ukraine by Natalia Ivanytska -- United Kingdom by Jeremy D. M. Robinson -- Part II - Protection and Disclosure of Know-How: International Report by Henrik Bengtsson -- Austria by Juliane Messner, Max W. Mosing and Rainer Schultes -- Belgium by Sophie Lens -- Brazil by Felipe Barros Oquendo -- Bulgaria by Teodora Tsenova -- France by Nizar Lajnef, Elisabeth Logeais, Vanessa Jiménez-Serrania and Guillaume Couet -- Germany by Thomas Hoeren -- Hungary by Miklós Boronkay -- Italy by Anna Gardini -- Japan by Takashi Koyama and Izumi Hayashi -- Luxembourg by Marianne Decker -- Romania by C?t?lin Grigorescu and Cristina Mihai -- Spain by Ana María Ruiz Martín -- Sweden by Magnus Tonell -- Switzerland by Charlotte Boulay -- The Netherlands by Vonne Laan and Mariko Kloppenburg -- Ukraine by Anton Polikarpov -- United Kingdom by Michael Browne -- United States of America by Emilio Varanini. 330 $aThis publication provides an unparalleled comparative analysis of two "hot topics" in the field of antitrust and unfair competition law with regard to a number of key countries. The first part of the book examines the prohibition of abuse of a dominant position and globalization in relation to two broad questions: first, whether there is consistency between the approaches of different jurisdictions to the notion of abuse, and, second, whether there are too many restrictions on legal rights and business opportunities resulting from the prohibition of abuse of dominance. The international report drafted by Professor Pinar Akman reveals that there are as many similarities as differences between the approaches of the twenty-one jurisdictions studied and presented in this book. This is an invitation to read the excellent international report as well as the reports on specific jurisdictions in order to grasp the variety of arguments and approaches of this antitrust area, which may, on the surface, appear alike. The second part gathers contributions on the question of protection and disclosure of trade secrets and know-how from various jurisdictions. The need for adequate protection of trade secrets has increased due to digitalization and the ease with which large volumes of misappropriated information can be reproduced. The comprehensive international report, prepared by Henrik Bengtsson, brings together these reflections by comparing various national positions. 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the United States Food and Drug Administration (FDA) and the European Medicines Agency (EMA), who provide through their respective websites, an abundance of guidance, especially in the last several years.  So much has changed since the 1st edition of this book was published in 2004.  There are now additional manufacturing processes for producing commercial biopharmaceuticals ? transgenic plant cell cultures and transgenic animals.  In addition to commercial recombinant proteins and monoclonal antibodies, there are now commercial cell-based medicines (cellular therapy) and DNA-based medicines (gene therapy).  Biosimilars are now on the marketplace in Europe, and under review for commercial approval in the USA.  Vaccine manufacturing has resurged due to the concerns of potentially pandemic mutated animal influenzas (e.g., swine flu, bird flu).  Strategic international regulatory guidances have been adopted that are driving the entire pharmaceutical industry, including biopharmaceuticals, to a higher standard of performance, including Quality by Design (QbD), Quality Risk Management (QRM) and Pharmaceutical Quality Systems (PQS).  The vast majority of the over 600 regulatory references listed in this book were either issued or updated since the release of the 1st edition.  All of these changes are the reason this updated edition includes not only biopharmaceuticals but also other biologics (e.g., live virus vaccines, human plasma-derived proteins, cell-based medicines, natural-sourced proteins) that have CMC regulatory compliance concerns and challenges in common with the genetically-engineered biologics (i.e., the biopharmaceuticals).      About The Author   John Geigert is President of BioPharmaceutical Quality Solutions, which specializes in providing CMC regulatory strategy consulting for the biopharmaceutical and biologic industry.  Dr. Geigert has over 35 years of CMC industrial experience and leadership in the biopharmaceutical industry.  Dr. Geigert has served on the PDA Board of Directors, co-chaired the PDA Biotech Advisory Board and served as an expert member of the USP Biotechnology Committee.  Dr. Geigert has written extensively for the Regulatory Affairs Professional Society (RAPS) Focus (What Senior Management Needs to Know About CMC Regulatory Compliance for Biotech Products (Aug-Nov 2009, 4-part series) and Demystifying CMC Regulatory Strategy (Sept 2011-Mar 2012, 4-part series)). 606 $aPharmaceutical biotechnology 606 $aPharmaceutical biotechnology industry$xLaw and legislation 606 $aPharmaceutical biotechnology$xQuality control 615 0$aPharmaceutical biotechnology. 615 0$aPharmaceutical biotechnology industry$xLaw and legislation. 615 0$aPharmaceutical biotechnology$xQuality control. 676 $a610 676 $a615.15 676 $a615.19 676 $a615.3 700 $aGeigert$b J$g(John),$f1948-$091349 801 0$bMiAaPQ 801 1$bMiAaPQ 801 2$bMiAaPQ 906 $aBOOK 912 $a9910437854103321 996 $aThe challenge of CMC regulatory compliance for biopharmaceuticals and other biologics$94195755 997 $aUNINA