Final answer:
New drug development involves three major tiers: initial drug discovery and development, pharmacokinetic evaluation in animal species, and regulatory approval for human use, requiring extensive testing to ensure safety and efficacy.
Step-by-step explanation:
New drug development is an intricate process that unfolds in three tiers. After initial discovery or synthesis of a compound, the development process involves chemically altering the drug, assessing its toxicity, and devising methods for its large-scale production. The subsequent tier is the pharmacokinetic evaluation, where the most promising compounds from the discovery stage are tested in at least two relevant animal species. This provides crucial data on the drug’s effects (pharmacodynamics), behavior within the body (pharmacokinetics), and potential toxicity. The final tier involves the approval process by regulatory bodies such as the FDA in the United States, ensuring the drug’s safety and effectiveness for human use. This includes several years of large-scale human trials to confirm that the drug is not harmful and effectively treats the targeted condition.
Each tier involves rigorous scrutiny and participation of a multidisciplinary team, including chemists, physicians, and scientists. The role of pharmacokinetics at each stage is vital in predicting how the drug behaves in the body, which guides dosage and administration strategies throughout the development cycle. The ultimate goal is to ensure that any new drug entering the market is both safe for consumption and beneficial for the condition it aims to treat.