Introduction to Early Drug Development

PART I: Drug Substance Early Phase API Process Development Overview The Discovery-Development API Transition API Cost of Goods: Discovery to Early Development New technologies in Process Development Case Study: Vortioxetine and Early Drug Development Considerations at the Interface of R&D Case study: Development of a Practical Synthesis of 4'-Azido-2'beta-Methyl-2'-Desoxycytosine and Its Prodrugs as HCV Chemotherapeutic Agents

PART II: Drug Product Solubility, Permeability, and their Interplay Drug Products: Solid-State Properties Salt and Cocrystal Screening Particle Size Reduction-From Microsizing to Nanosizing Drug Product Formulation A Practical Guide for the Preparation of Drug Nanosuspensions for Preclinical and Early Drug Development Studies

PART III: Pharmacokinetics and Pharmacodynamics Integration of Pharmacokinetic and Pharmacodynamic Reasoning and Its Importance in Early Drug Development Prediction of Human Pharmacokinetics and Pharmacodynamics Translational Modeling and Simulation for Molecularly Targeted Small Molecule Anticancer Agents: Case Studies of Multiple Tyrosine Kinase Inhibitors, Crizotinib and Lorlatinib Informing Decisions in Discovery and Early Development Research Through Quantitative and Translational Modeling

PART IV: Toxicology Pre-clinical Toxicology Evaluation Non-clinical Safety Pharmacology Predictive Computational Toxicology Addressing Genotoxicity Risk: A PDE10A Inhibitor Case Study The Integrated Optimisation of Safety and DMPK Properties Enabling Preclinical Development: A Case History with S1P1 Agonists From TRAIL to ONC201: Case Study on the Safety Benefit of Developing Targeted Agents Against Cancer-Selective Pathways

PART V: Intellectual Property Patent Law Relevant to Early Drug Development Patent Protection Strategy The Patent Landscape Viewed from Generic and Originator Perspectives Patent Considerations in Collaborative Drug Development