New alternative methods in drug safety assessment

Abstract

The book, intended for biomedical researchers, attempts to foster a comprehensive understanding of the elements that impact scientific research, such as clinical trial design, communication, and publication methods.

It introduces the process of idea generation and creative/critical thinking, leading to the development of key concepts that coalesce into theoretical constructs and working hypotheses. The book systematically delineates research phases associated with a bench-to-bedside translational approach, providing the full depth and breadth of drug discovery and development: design, synthesis, and optimization of drug candidates interacting with targets linked to diseases, as well as clinical trial design to acquire substantial evidence of efficacy and safety for candidate drugs in the target patient population.

New and evolving topics such as artificial intelligence, machine and deep learning, drug repurposing approaches, and bioinformatics, are incorporated into the text as these features are becoming integrated into drug research and development. Additionally, it covers publication strategies, including literature search, manuscript preparation, data presentation, relevant discussion, editorial processes, elements of peer review, and bibliometrics. Finally, the book addresses grantsmanship, key strategies for building effective networks, mentorships, maintaining research integrity, and forging career advancement opportunities, including entrepreneurship.