Shanghai Medicilon Inc.

QbD (Quality by Design) is a systematic pharmaceutical development concept that emphasizes designing the quality of the product throughout the entire drug development and production process. It involves considering the quality of the final product from the very beginning of the development phase.  Based on existing experience and risk assessment, in-depth research should be conducted on various aspects such as material selection, formulation design, determination of process routes, and control of process parameters.  Although the development process becomes more complex, the advantages brought by the QbD approach are evident. These advantages include reducing quality risks, improving the predictability and controllability of the production process, accelerating the time to market, and enhancing the product’s competitiveness. Medicilon Cloud Lecture Hall invites Dr. Binbin Liu to share his practical experience and insights on applying the QbD concept in pharmaceutical formulation develo

There are various research methods for the solid-state characterization of drugs. With its inherent advantages, X-ray powder diffraction (XRPD) has been widely used in the qualitative and quantitative studies of drug solid states. Research and exploration of XRPD are present throughout all stages of drug solid-state research. XRPD provides indirect information on the structural parameters of compounds, which can vary greatly depending on the structure of the material. So, how should diffraction patterns be interpreted? How can we use XRPD patterns to understand the crystallinity of a sample and whether the crystal form is consistent across batches? Cloud Lecture Hall invites Mr. Zhonghua Zhang, who has many years of experience in solid-state development, to share his expertise in interpreting spectra through practical cases. He will also address how to resolve the difficulties encountered in experiments. Q: Is the error between the actual sample diffraction peak value and the CCDC simu

  API quality research is not only a technical discussion but also a core issue concerning the safety and efficacy of medications.  In modern pharmaceutical research, it is crucial to fully understand the properties and characteristics of APIs, ensure consistency and stability in the manufacturing process, and improve the quality and reliability of medications.  During API quality research, many challenges arise: how to handle issues when they occur, which guidelines to follow, and how to deal with supplementary data requests. Medicilon’s Cloud Lecture Hall invites Jianmei Wang from the Process Department to provide a comprehensive and in-depth analysis of API quality research from multiple perspectives.  Jianmei will address potential issues in API quality research and explain how to effectively handle them one by one. 01 How should the deuteration ratio of deuterated drugs be studied? Are there any relevant guidelines that can be referenced? What are the CDE's requirements for th