Final answer:
In pharmaceutical drug development, animal research is essential during the early stages for determining a drug's safety and efficacy. Clinical trials follow, adhering to strict ethical guidelines, before a drug can be approved for human use.
Step-by-step explanation:
Phases in Pharmaceutical Drug Development
The development of pharmaceutical drugs is a complex process, beginning with the initial discovery or synthesis of a compound. Subsequently, chemists develop and possibly alter the compound, assess its toxicity, and design methods for efficient large-scale production.
One of the critical early phases involves pharmacokinetic evaluation, which is conducted on animals to understand the drug's behavior in the body. In this phase, scientists gather pharmacodynamic, pharmacokinetic, and toxicological data that are vital for progressing the drug to clinical trials in humans. This is where the role of animal research is instrumental, as it helps ascertain the safety and efficacy before administering the drug to humans.
Following successful animal testing, the drug goes through a rigorous process of clinical trials, by ethical guidelines and regulations set by entities like the International Conference on Harmonisation (ICH), the European Medicines Agency (EMA), and the Food and Drug Administration (FDA). These trials, starting with phase I, evaluate whether the compound is safe, tolerable, and has suitable pharmacokinetic properties in human subjects. Only after passing through several trial phases can the drug receive approval for public use.
Thus, contrary to the claims of options B and D, animal research plays a crucial role in drug development, particularly in the early stages. It is also evident that ethical guidelines are deeply considered throughout the drug approval process, opposing the assertion made by option D.