Do you think it is appropriate to do pharmacokinetic, pharmacodynamic, and toxicology studies in animals before testing an investigative product in humans? Why or why not?
It is important to do toxicology, pharmacodynamics and pharmacokinetic studies on animals before the tests of the resultant products are carried out on humans. The testing ensures that the various effects of the drug including metabolism and how the drugs reacts in the presence of different drugs is analyzed to prevent any harm that may arise when the drugs are used by humans (Ludolph et al., 2010). Therefore testing all the possibilities of safety of the drug is important to prevent any adverse effects on the human beings.
How do researchers use the pharmacokinetic, pharmacodynamic, and toxicology data obtained in preclinical trials to assess risks and to develop a Phase I protocol in humans?
Pharmacokinetic data is very important in building on the Phase I protocol as it help to determine how the active ingredients of the drug work in the animal then human, and how it is spread throughout the body and its final removal from the body of humans. The data from a pharmacodynamics tests give clarity on the functioning of the drug in the body and how the amount that is needed to bring about an effect. Toxicology data gives the highest dose that can be tolerated by the body in producing the effect desired. Therefore the three tests provide critical information that can be used to build phase I protocol which further ensures whether the drugs are safe for humans or not and how they are to be used in terms of dosage and their health benefit (Fisher et al., 2008).
Is it important to see acute toxicity at the highest dose in animals? Why or why not?
Acute toxicity involves the various tests done on animals to determine the adverse effects especially after the administration of a single dose of the drug. It is important to analyze acute toxicity at high doses as it helps determine the harmful effects that can occur should someone take the wrong dosage of the drug especially in large doses. The adverse effects found after acute toxicity help the manufacturers to determine ways to reduce them. It is therefore important to consider acute toxicity at highest doses as it will help the various researchers to come up with tests and solutions that will help in reducing the adverse effects in human beings.