Early Drug Development: Strategies and Routes to by Mitchell N. Cayen

By Mitchell N. Cayen

The focal point of early drug improvement has been the submission of an Investigational New Drug software to regulatory organizations. Early Drug improvement: suggestions and Routes to First-in-Human Trials publications drug improvement firms in getting ready and filing an Investigational New Drug (IND) software. via explaining the nuts and bolts of preclinical improvement actions and their interaction in successfully making a choice on winning medical applicants, the booklet is helping pharmaceutical scientists ascertain what different types of discovery and preclinical learn stories are wanted that allows you to aid a submission to regulatory businesses.

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Indeed, formulation issues can influence the design of the lead molecules and feed back into the iterative lead optimization cycle as well as nonclinical and clinical evaluations. , by enhancing absorption through their interaction with the cell membrane of the gastrointestinal tract) and solubility for systemically administered drugs. Indeed, a significant number of drug 14 DRUG DISCOVERY AND EARLY DRUG DEVELOPMENT discovery and development programs center around new ways of formulating known or marketed drugs in order to improve on their pharmacokinetic profiles, thereby enhancing their safety and/or efficacy characteristics, or improving on the dose regimen (dose level or dose frequency).

However, most drug sponsors would want to assure that most of these key properties have been studied prior to recommendation for preFIH development. In the chapters that follow, the assumption is made that the first seven properties—potency, selectivity, biology, chemical stability, chirality, patent status, and physicochemistry—have been studied appropriately such that the emerging NCEs can proceed through the gate for evaluation. Discussions are presented on the lead optimization and pre-FIH development programs principally for orally administered small-molecule drugs and systemically administered biotherapeutics, along with the regulatory expectations and various planning strategies for the critically important FIH trial.

Contract Pharma. Mar. 2009;36–38. Available at: www. com. 14. Hoang T. Contract Research Helps Keep Drug Pipelines Flowing. Sector Focus Report. Berwyn, PA: Turner Capital Investment; July 2008. Available at: www. detail/ID/2661/CSID/387/. PART II LEAD OPTIMIZATION STRATEGIES 2 ADME STRATEGIES IN LEAD OPTIMIZATION Amin A. 1 INTRODUCTION Drug discovery is a highly complex, dynamic, and evolving process; it requires highly skilled and trained people of many scientific disciplines who not only must master the relevant science but must also be able to work together as a team.

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