The regulatory process involves various stages, including preclinical testing, clinical trials, and post-marketing surveillance. During these phases, both the API and the finished drug product are assessed for safety, efficacy, and quality. Regulatory authorities worldwide have established guidelines to standardize the assessment process, thus facilitating international trade and ensuring patient safety.
The development of an API involves several stages, including discovery, synthesis, formulation, and testing. Initially, researchers identify potential compounds that exhibit desirable biological activity. Subsequent phases involve the synthesis of these compounds in the laboratory, followed by formulation into dosage forms (e.g., tablets, injectables). Rigorous testing is conducted to assess the pharmacokinetics, pharmacodynamics, and toxicological profiles of the drug candidates.
A robust immune system is essential for overall health, and PQQ may help bolster the immune response. By promoting cellular health and reducing inflammation, PQQ can assist the body in fighting off infections and diseases. Some studies have suggested that PQQ could enhance the function of immune cells, leading to a stronger immune response.