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  6.  » Meeting the Needs of Early-Phase Drug Sponsors with HPAPIs in the Pipeline

Meeting the Needs of Early-Phase Drug Sponsors with HPAPIs in the Pipeline

Summary:​​ The early development of highly potent active pharmaceutical ingredients (APIs) presents early-phase drug sponsors with unique and complex challenges. One of the primary hurdles in handling these APIs is their potential harm to humans and the environment, necessitating strict safety precautions throughout the development and manufacturing process. Furthermore, these APIs often exhibit poor solubility, instability, and poor bioavailability. To effectively address these issues, it is necessary to have facilities equipped with containment technologies to safeguard personnel and the environment. The formulation and manufacturing of highly potent APIs must also adhere to best practices that manage the risks associated with exposure during production while ensuring the API’s efficacy and stability throughout formulation.

This webinar aims to address the specific needs of these sponsors by providing valuable insights and practical strategies. Experts will explore various aspects, including formulation considerations, safety protocols, regulatory compliance, and risk management associated with HPAPIs.

Click here to view the webinar