Pharma, Pharmaceutics and Biotechnology Conference

Pre-clinical research is an important step for drug development between the laboratory discovery and human clinical trials. This session focuses on methodologies and the importance of preclinical studies, always emphasizing how they can guarantee potential therapeutic agents will be safe and effective before they enter human clinical trials. Major goals of any preclinical studies include assessing the PK, PD, and safety profile of a drug candidate.

Mostly these are usually done through laboratory experiments and models using animals to assess how a drug behaves in the body by absorption, distribution, metabolism, and excretion. All these have benefits in optimizing dosage strategies and probable side effects. The basis of preclinical research work lies in the safety assessment. Toxicological studies are conducted to properly establish the potential toxic effects the drug may pose to the various organ systems in the human body.

This study helps the investigator understand the dose response relationship, define the safety margins for advancing to human experiments, and, by using standardized animal models, he can critically assess the effect of the drug in a living system to gain critical insight into potential adverse reactions that could manifest in clinical life.

It also plays a very important role in the development of drugs, as most of the effective formulations are developed through preclinical studies. Scientists test different formulations and modes of delivery for maximum bioavailability and potency of the drug.

Sometimes, there is a trial stage which involves some chemical refinement of the drug to make the drug stable and potent. The central transition in the drug development process comes when data from successful preclinical studies are used to support IND applications to regulatory agencies, thereby allowing research to begin in humans. Information gained during preclinical research also guides clinical protocols and informs patient populations that would most likely benefit from this new therapy.

The session will provide a much more in-depth overview of the process of preclinical research, including best practices and new methodologies. It emphasizes the significance that preclinical research plays in the drug development continuum.

The data presented will cover challenges that are currently associated with the specific progress made through the preclinical study phase.