Early Drug Development : Bringing a Preclinical Candidate to the Clinic /: Bringing a Preclinical Candidate to the Clinic. (2018)

• Record Type: Book
• Further Information: Note: Fabrizio Giordanetto, Raimund Mannhold, Helmut Buschmann, Jörg Holenz.
• Editors: Giordanetto, Fabrizio; Mannhold, Raimund; Buschmann, Helmut; Holenz, Jörg
• Contents: 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 Jørgensen, 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; Sébastien 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. Göhlmann 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
• Edition: 1st
• Publisher Details: Wiley-VCH
• Publication Date: 2018
• Extent: 1 online resource (400 pages)
• Languages: English
• ISBNs: 9783527801770
• Access Rights: Legal Deposit; Only available on premises controlled by the deposit library and to one user at any one time; The Legal Deposit Libraries (Non-Print Works) Regulations (UK).
• Access Usage: Restricted: Printing from this resource is governed by The Legal Deposit Libraries (Non-Print Works) Regulations (UK) and UK copyright law currently in force.