The therapeutic window is determined through extensive clinical trials and research. The process involves: 1. Preclinical Studies: Initial tests on animals to understand the drug's effects and toxicity. 2. Phase I Trials: Assessing safety and dosage in a small group of healthy individuals. 3. Phase II and III Trials: Evaluating efficacy and side effects in larger patient populations. 4. Post-Market Surveillance: Ongoing monitoring of drug safety after it has been released to the market.