Early Drug Development : Bringing a Preclinical Candidate to the Clinic
著者
書誌事項
Early Drug Development : Bringing a Preclinical Candidate to the Clinic
（Methods and principles in medicinal chemistry / edited by R. Mannhold ... [et al.], 73）
Wiley-VCH : Wiley, c2018
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注記
Includes bibliographical references and index
内容説明・目次
内容説明
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.
目次
- Contents to Volume 1 Preface xv A Personal Foreword xix 1 Early Drug Development: Progressing a Candidate Compound to the Clinics 1 Fabrizio Giordanetto References 7 Part I Drug Substance 9 2 Early Phase API Process Development Overview 11 J. Christopher McWilliams and Mark Guinn 3 The Discovery/Development Transition 31 Christopher M. Cimarusti and David R. Kronenthal 4 Active Pharmaceutical Ingredient Cost of Goods: Discovery to Early Development 49 Neal G. Anderson and Todd D. Nelson 5 New Technologies in Process Development 73 Peter W. Sutton, Joseph P. Adams, Charles Wade, and Katherine Wheelhouse 6 Vortioxetine and Early Drug Development Considerations at the Interface of R&D 125 Morten Jorgensen, Kim Christensen, Martin Juhl, and Benny Bang-Andersen 7 Development of a Practical Synthesis of 4'-Azido-2'
- -Methyl-2'-Desoxycytosine and Its Prodrugs as HCV Chemotherapeutic Agents 145 Sebastien Lemaire, Tom Govaerts, and Vittorio Farina Part II Drug Product 169 8 Solubility, Permeability, and Their Interplay 171 Avital Beig, Milica Markovic, and Arik Dahan 9 Solid-State Properties 203 Si-Wei Zhang, Robert F. Dunn, and Alfred Y. Lee 10 Salt and Cocrystal Screening 229 Ann Newman, Cen Chen, and Carlos Sanrame 11 Particle Size Reduction: From Microsizing to Nanosizing 271 Dedong Wu and Beth A. Sarsfield 12 Early Drug Development: From a Drug Candidate to the Clinic 305 Mark McAllister, Joanne Bennett, John Davis, Brian Henry, and MeiWong 13 A Practical Guide for the Preparation of Drug Nanosuspensions for Preclinical Studies: Including In Vivo Case Studies 333 Kalle Sigfridsson, Urban Skantze, Pia Skantze, and Lennart Lindfors Contents to Volume 2 A Personal Foreword xxiii Part III Pharmacokinetics and Pharmacodynamics 365 14 Integration of Pharmacokinetic and Pharmacodynamic Reasoning and Its Importance in Drug Discovery 367 Johan Gabrielsson and Stephan Hjorth 15 Prediction of Human Pharmacokinetics and Pharmacodynamics 399 Ulf Bredberg 16 Translational Modeling and Simulation for Molecularly Targeted Small Molecule Anticancer Agents: Case Studies of Multiple Tyrosine Kinase Inhibitors, Crizotinib and Lorlatinib 433 Shinji Yamazaki 17 Informing Decisions in Discovery and Early Development Research Through Quantitative and Translational Modeling 467 Tjerk 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. Visser Contents to Volume 2 Part IV Toxicology 497 18 Preclinical Toxicology Evaluation 499 Sara Moses, Ulf Andersson, and Martin Billger 19 Nonclinical Safety Pharmacology 527 Bruce H. Morimoto 20 Early Drug Development 549 Luis G. Valerio Jr. 21 Addressing Genotoxicity Risk in Lead Optimization: A PDE10A Inhibitor Case Study 581 Bie M. P. Verbist, Marjolein Crabbe, Freddy Van Goethem, and Hinrich W. H. Goehlmann 22 The Integrated Optimization of Safety and DMPK Properties Enabling Preclinical Development: A Case History with S1P1 Agonists 603 Simon Taylor 23 From TRAIL to ONC201: Case Study on the Safety Benefit of Developing Targeted Agents Against Cancer-selective Pathways 631 Christina 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-Deiry Part V Intellectural Property 647 24 Patent Law Relevant to Early Drug Development 649 Joanna T. Brougher Esq.,MPH and Audrey Ogurchak 25 Patent Protection Strategy 667 Mark A. Borsos 26 Intellectual Property: The Patent Landscape Viewed from Generic and Originator Perspectives 691 Jonathan D.M. Atkinson D.Phil
- EPA
- C Chem. FRSC 27 Patent Considerations in Collaborative Drug Development 721 Mary Anne Armstrong Index 749
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