ABSTRACT
The potential to prevent and treat disease has improved extraordinarily due to the discovery and development of new drugs and biopharmaceuticals. The pathogenesis of many disorders has become better understood as our knowledge of immune mechanisms, molecular structures of drugs and biologics, and biotechnology has expanded. Many new antibiotics to treat infections and therapeutics to treat cancers and chronic diseases have been developed over the past decades. Biotechnology provides effective methods for identifying new molecules for the pharmaceutical industry and facilitates the process of drug development. Preclinical research allows evaluation of the pharmacokinetics, pharmacodynamics, dose-response profiles, and toxicological potential of a drug. Preclinical studies also determine the optimal formulation and dose for phase I clinical trials, analyze physicochemical characteristics of the testing compound, and provide the rationale for the proposed therapeutic indication. The information gained from animal safety tests is used to predict and characterize potential adverse effects in humans. The new drug candidates also undergo analysis for physicochemical characterization, including identity, strength, purity, and stability.
