Details

Early Drug Development


Early Drug Development

Bringing a Preclinical Candidate to the Clinic
Methods & Principles in Medicinal Chemistry 1. Aufl.

von: Fabrizio Giordanetto, Raimund Mannhold, Helmut Buschmann, Jörg Holenz

282,99 €

Verlag: Wiley-VCH
Format: EPUB
Veröffentl.: 15.06.2018
ISBN/EAN: 9783527801770
Sprache: englisch
Anzahl Seiten: 816

DRM-geschütztes eBook, Sie benötigen z.B. Adobe Digital Editions und eine Adobe ID zum Lesen.

Beschreibungen

This one-stop reference systematically covers key aspects in early drug development that are directly relevant to the discovery phase and are required for first-in-human studies. <br> Its broad scope brings together critical knowledge from many disciplines, ranging from process technology to pharmacology to intellectual property issues.<br> After introducing the overall early development workflow, the critical steps of early drug development are described in a sequential and enabling order: the availability of the drug substance and that of the drug product, the prediction of pharmacokinetics and -dynamics, as well as that of drug safety. The final section focuses on intellectual property aspects during early clinical development. The emphasis throughout is on recent case studies to exemplify salient points, resulting in an abundance of practice-oriented information that is usually not available from other sources.<br> Aimed at medicinal chemists in industry as well as academia, this invaluable reference enables readers to understand and navigate the challenges in developing clinical candidate molecules that can be successfully used in phase one clinical trials.
<p><b>Contents to Volume 1</b></p> <p>Preface xv</p> <p>A Personal Foreword xix</p> <p>1 Early Drug Development: Progressing a Candidate Compound to the Clinics 1<br /><i>Fabrizio Giordanetto</i></p> <p>References 7</p> <p><b>Part I Drug Substance 9</b></p> <p>2 Early Phase API Process Development Overview 11<br /><i>J. Christopher McWilliams and Mark Guinn</i></p> <p>3 The Discovery/Development Transition 31<br /><i>Christopher M. Cimarusti and David R. Kronenthal</i></p> <p>4 Active Pharmaceutical Ingredient Cost of Goods: Discovery to Early Development 49<br /><i>Neal G. Anderson and Todd D. Nelson</i></p> <p>5 New Technologies in Process Development 73<br /><i>Peter W. Sutton, Joseph P. Adams, Charles Wade, and Katherine Wheelhouse</i></p> <p>6 Vortioxetine and Early Drug Development Considerations at the Interface of R&D 125<br /><i>Morten Jørgensen, Kim Christensen, Martin Juhl, and Benny Bang-Andersen</i></p> <p>7 Development of a Practical Synthesis of 4′-Azido-2′;;-Methyl-2′-Desoxycytosine and Its Prodrugs as HCV Chemotherapeutic Agents 145<br /><i>Sébastien Lemaire, Tom Govaerts, and Vittorio Farina</i></p> <p><b>Part II Drug Product 169</b></p> <p>8 Solubility, Permeability, and Their Interplay 171<br /><i>Avital Beig, Milica Markovic, and Arik Dahan</i></p> <p>9 Solid-State Properties 203<br /><i>Si-Wei Zhang, Robert F. Dunn, and Alfred Y. Lee</i></p> <p>10 Salt and Cocrystal Screening 229<br /><i>Ann Newman, Cen Chen, and Carlos Sanrame</i></p> <p>11 Particle Size Reduction: From Microsizing to Nanosizing 271<br /><i>Dedong Wu and Beth A. Sarsfield</i></p> <p>12 Early Drug Development: From a Drug Candidate to the Clinic 305<br /><i>Mark McAllister, Joanne Bennett, John Davis, Brian Henry, and MeiWong</i></p> <p>13 A Practical Guide for the Preparation of Drug Nanosuspensions for Preclinical Studies: Including In Vivo Case Studies 333<br /><i>Kalle Sigfridsson, Urban Skantze, Pia Skantze, and Lennart Lindfors</i></p> <p><b>Contents to Volume 2</b></p> <p>A Personal Foreword xxiii</p> <p><b>Part III Pharmacokinetics and Pharmacodynamics 365</b></p> <p>14 Integration of Pharmacokinetic and Pharmacodynamic Reasoning and Its Importance in Drug Discovery 367<br /><i>Johan Gabrielsson and Stephan Hjorth</i></p> <p>15 Prediction of Human Pharmacokinetics and Pharmacodynamics 399<br /><i>Ulf Bredberg</i></p> <p>16 Translational Modeling and Simulation for Molecularly Targeted Small Molecule Anticancer Agents: Case Studies of Multiple Tyrosine Kinase Inhibitors, Crizotinib and Lorlatinib 433<br /><i>Shinji Yamazaki</i></p> <p>17 Informing Decisions in Discovery and Early Development Research Through Quantitative and Translational Modeling 467<br /><i>Tjerk Bueters, Christopher R. Gibson, Prajakti A. Kothare,Mallika Lala, Eric M. Parker,Matthew L. Rizk,</i> <i>Daniel Tatosian, Maria E. Trujillo, Pavan Vaddady, and Sandra A.G. Visser</i></p> <p><b>Contents to Volume 2</b></p> <p><b>Part IV Toxicology 497</b></p> <p>18 Preclinical Toxicology Evaluation 499<br /><i>Sara Moses, Ulf Andersson, and Martin Billger</i></p> <p>19 Nonclinical Safety Pharmacology 527<br /><i>Bruce H. Morimoto</i></p> <p>20 Early Drug Development 549<br /><i>Luis G. Valerio Jr.</i></p> <p>21 Addressing Genotoxicity Risk in Lead Optimization: A PDE10A Inhibitor Case Study 581<br /><i>Bie M. P. Verbist, Marjolein Crabbe, Freddy Van Goethem, and Hinrich W. H. Göhlmann</i></p> <p>22 The Integrated Optimization of Safety and DMPK Properties Enabling Preclinical Development: A Case History with S1P1 Agonists 603<br /><i>Simon Taylor</i></p> <p>23 From TRAIL to ONC201: Case Study on the Safety Benefit of Developing Targeted Agents Against Cancer-selective Pathways 631<br /><i>Christina Leah B. Kline, JessicaWagner, Amriti Lulla,Marie D. Ralff, Avital Lev, Lanlan Zhou, Varun V.</i> <i>Prabhu, Martin Stogniew, Lee Schalop,Wolfgang Oster, Joshua E. Allen, andWafik S. El-Deiry</i></p> <p><b>Part V Intellectural Property 647</b></p> <p>24 Patent Law Relevant to Early Drug Development 649<br /><i>Joanna T. Brougher Esq.,MPH and Audrey Ogurchak</i></p> <p>25 Patent Protection Strategy 667<br /><i>Mark A. Borsos</i></p> <p>26 Intellectual Property: The Patent Landscape Viewed from Generic and Originator Perspectives 691<br /><i>Jonathan D.M. Atkinson D.Phil; EPA; C Chem. FRSC</i></p> <p>27 Patent Considerations in Collaborative Drug Development 721<br /><i>Mary Anne Armstrong</i></p> <p>Index 749</p>
<p>Fabrizio Giordanetto graduated in Medicinal Chemistry (Genoa, Italy) followed by his Ph.D. (London, UK) while working for the chemistry unit of Pharmacia – Pfizer (Italy). After positions at AstraZeneca (Sweden) as Principal Scientist and Project Leader and at Taros (Germany) as Head of Medicinal Chemistry, he has recently joined DE Shaw Research LLC (New York, USA) where he leads medicinal chemistry activities and drug discovery projects. During his career, he worked on several drug discovery programs resulting in multiple clinical candidates spanning oncology, CNS, inflammation, metabolic and cardiovascular indications and >100 international patents, peer–reviewed publications and book chapters.</p>

Diese Produkte könnten Sie auch interessieren:

Hot-Melt Extrusion
Hot-Melt Extrusion
von: Dennis Douroumis
PDF ebook
136,99 €
Hot-Melt Extrusion
Hot-Melt Extrusion
von: Dennis Douroumis
EPUB ebook
136,99 €
Kunststoffe
Kunststoffe
von: Wilhelm Keim
PDF ebook
99,99 €