Early Drug Development, 2 Volume Set

Bringing a Preclinical Candidate to the Clinic

Inbunden, Engelska, 2018

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Beskrivning

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. Its broad scope brings together critical knowledge from many disciplines, ranging from process technology to pharmacology to intellectual property issues.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.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.

Produktinformation

Utgivningsdatum:2018-08-01
Mått:178 x 252 x 46 mm
Vikt:1 860 g
Format:Inbunden
Språk:Engelska
Antal sidor:816
Förlag:Wiley-VCH Verlag GmbH
ISBN:9783527341498

Utforska kategorier

Kemi inom Naturvetenskap och teknik
Tillverkningsteknik inom Naturvetenskap och teknik

Mer om författaren

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.

Innehållsförteckning

Contents to Volume 1Preface xvA Personal Foreword xix1 Early Drug Development: Progressing a Candidate Compound to the Clinics 1Fabrizio GiordanettoReferences 7Part I Drug Substance 92 Early Phase API Process Development Overview 11J. Christopher McWilliams and Mark Guinn3 The Discovery/Development Transition 31Christopher M. Cimarusti and David R. Kronenthal4 Active Pharmaceutical Ingredient Cost of Goods: Discovery to Early Development 49Neal G. Anderson and Todd D. Nelson5 New Technologies in Process Development 73Peter W. Sutton, Joseph P. Adams, Charles Wade, and Katherine Wheelhouse6 Vortioxetine and Early Drug Development Considerations at the Interface of R&D 125Morten Jørgensen, Kim Christensen, Martin Juhl, and Benny Bang-Andersen7 Development of a Practical Synthesis of 4′-Azido-2′;;-Methyl-2′-Desoxycytosine and Its Prodrugs as HCV Chemotherapeutic Agents 145Sébastien Lemaire, Tom Govaerts, and Vittorio FarinaPart II Drug Product 1698 Solubility, Permeability, and Their Interplay 171Avital Beig, Milica Markovic, and Arik Dahan9 Solid-State Properties 203Si-Wei Zhang, Robert F. Dunn, and Alfred Y. Lee10 Salt and Cocrystal Screening 229Ann Newman, Cen Chen, and Carlos Sanrame11 Particle Size Reduction: From Microsizing to Nanosizing 271Dedong Wu and Beth A. Sarsfield12 Early Drug Development: From a Drug Candidate to the Clinic 305Mark McAllister, Joanne Bennett, John Davis, Brian Henry, and MeiWong13 A Practical Guide for the Preparation of Drug Nanosuspensions for Preclinical Studies: Including In Vivo Case Studies 333Kalle Sigfridsson, Urban Skantze, Pia Skantze, and Lennart LindforsContents to Volume 2A Personal Foreword xxiiiPart III Pharmacokinetics and Pharmacodynamics 36514 Integration of Pharmacokinetic and Pharmacodynamic Reasoning and Its Importance in Drug Discovery 367Johan Gabrielsson and Stephan Hjorth15 Prediction of Human Pharmacokinetics and Pharmacodynamics 399Ulf Bredberg16 Translational Modeling and Simulation for Molecularly Targeted Small Molecule Anticancer Agents: Case Studies of Multiple Tyrosine Kinase Inhibitors, Crizotinib and Lorlatinib 433Shinji Yamazaki17 Informing Decisions in Discovery and Early Development Research Through Quantitative and Translational Modeling 467Tjerk Bueters, Christopher R. Gibson, Prajakti A. Kothare,Mallika Lala, Eric M. Parker,Matthew L. Rizk, Daniel Tatosian, Maria E. Trujillo, Pavan Vaddady, and Sandra A.G. VisserContents to Volume 2Part IV Toxicology 49718 Preclinical Toxicology Evaluation 499Sara Moses, Ulf Andersson, and Martin Billger19 Nonclinical Safety Pharmacology 527Bruce H. Morimoto20 Early Drug Development 549Luis G. Valerio Jr.21 Addressing Genotoxicity Risk in Lead Optimization: A PDE10A Inhibitor Case Study 581Bie M. P. Verbist, Marjolein Crabbe, Freddy Van Goethem, and Hinrich W. H. Göhlmann22 The Integrated Optimization of Safety and DMPK Properties Enabling Preclinical Development: A Case History with S1P1 Agonists 603Simon Taylor23 From TRAIL to ONC201: Case Study on the Safety Benefit of Developing Targeted Agents Against Cancer-selective Pathways 631Christina Leah B. Kline, JessicaWagner, Amriti Lulla,Marie D. Ralff, Avital Lev, Lanlan Zhou, Varun V. Prabhu, Martin Stogniew, Lee Schalop,Wolfgang Oster, Joshua E. Allen, andWafik S. El-DeiryPart V Intellectural Property 64724 Patent Law Relevant to Early Drug Development 649Joanna T. Brougher Esq.,MPH and Audrey Ogurchak25 Patent Protection Strategy 667Mark A. Borsos26 Intellectual Property: The Patent Landscape Viewed from Generic and Originator Perspectives 691Jonathan D.M. Atkinson D.Phil; EPA; C Chem. FRSC27 Patent Considerations in Collaborative Drug Development 721Mary Anne ArmstrongIndex 749