Several factors are considered in determining the optimal dose for cancer patients:
1. Phase I Clinical Trials: These trials are the first step in testing a new treatment in humans. The primary goal is to find the maximum tolerated dose (MTD) by gradually increasing the dose until adverse effects become unacceptable.
2. Pharmacokinetics (PK) and Pharmacodynamics (PD): PK studies how the drug is absorbed, distributed, metabolized, and excreted in the body. PD examines the effects of the drug on the body. Together, they help in understanding the dose-response relationship.
3. Biomarkers: Biomarkers are biological molecules found in blood, other body fluids, or tissues that indicate the presence or severity of a disease. They can help in personalizing the dose according to the patient's specific condition.
4. Computer Simulations and Modeling: Advanced computational methods can simulate how different doses affect both healthy and cancerous cells, helping to predict the optimal dose.