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Once a viable API is developed, extensive clinical trials are conducted to evaluate its safety and efficacy in humans. Regulatory bodies, such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), require comprehensive data on the API before granting approval for the drug's market release. These regulatory frameworks ensure that only safe and effective medicines reach patients.

Studies have shown that PQQ administration can lead to improvements in cognitive function, memory, and overall brain health. Its ability to enhance energy metabolism and reduce inflammation further supports its role as a neuroprotective agent.

Safety is a critical aspect of using pentoxifylline. The drug is generally well-tolerated, but side effects can occur. Common adverse effects include gastrointestinal issues such as nausea, vomiting, and diarrhea. More serious, but rarer side effects include hypotension and bleeding complications, especially if the patient is on anticoagulant therapy.

Non-compliance with these regulations can result in severe consequences, including drug recalls, market withdrawals, and legal action. Therefore, pharmaceutical companies invest significantly in quality assurance programs to maintain the integrity of their APIs.