临床药理学与生物药剂学

抽象的

Preclinical Safety Evaluation of Biopharmaceuticals: Ensuring Efficacy and Safety

Tam Phan

Biopharmaceuticals, including monoclonal antibodies, gene therapies, and cell-based therapies, represent a promising frontier in modern medicine, offering innovative treatments for various diseases. Ensuring the efficacy and safety of these advanced therapeutic modalities is paramount in their development and regulatory approval. Preclinical safety evaluation plays a pivotal role in this process. This abstract provides an overview of the key aspects of preclinical safety evaluation for biopharmaceuticals, highlighting its importance in the drug development pipeline. The preclinical phase involves a comprehensive assessment of these innovative therapies, encompassing in vitro and in vivo studies, safety pharmacology, toxicology, and immunogenicity testing. Rigorous evaluation at this stage helps to identify potential risks, optimize dosing regimens, and refine development strategies before progressing to clinical trials. Preclinical safety evaluation of biopharmaceuticals is an essential step in the drug development process, safeguarding the well-being of patients and bolstering confidence in these innovative therapies. Its rigorous methodologies and risk assessment strategies contribute significantly to the development of safe and effective biopharmaceuticals, ultimately enhancing the landscape of modern medicine.