Final answer:
The requirements for substitution of dosage forms include determining the pharmacokinetic profile, investigating the food effect on pharmacokinetics, and selecting the best formulation for drug exposure and administration route.
Step-by-step explanation:
The requirements for substitution of dosage forms include determining the pharmacokinetic profile of new formulations, investigating the food effect on pharmacokinetics, and selecting the best formulation for drug exposure and administration route. The dosage and route of administration are important factors to consider when determining the dosage for a medication, taking into account the patient's mass, potential side effects, and drug metabolism or clearance from the body. These requirements ensure that the optimum therapeutic drug levels are achieved without causing significant toxicity to the patient.