Medicine bigwigs gather together to teach you to play "how to develop high quality chemicals"!

"According to the data in the FDA orange book, the ratio of the number of generic drugs in China and India is 13:879, 106:1517 by 2015; in terms of new drug research and development, the number of Chinese chemical drugs in category 1.1 application is growing slowly, especially compared with India, a developing country..." On the morning of September 11, Cao Xiaoping, chairman of ISPE China chemical and pharmaceutical Commission, revealed the current situation of the development of new drugs in China through the above data in Suzhou Nanyuan Hotel, which opened the curtain of the 40th issue of "how to develop high-quality chemicals" Nearly 30 medical industry executives from all over the country have expressed their opinions, sought common ground while reserving differences, and launched a hurricane like "brainstorming"; nearly a thousand medical industry people sit on the table, listen attentively, and enjoy the medical feast In addition to the report, experts, senior executives of pharmaceutical companies, and R & D personnel do not forget to compete with each other, which makes the collision of ideas create a spark of wisdom for new drug R & D With freehand brushwork, the group gathered together to discuss the research and development of high-quality chemicals in order to reveal the essence of drug research and development, pharmaceutical technology and regulations, and integrate the insights of pharmaceutical enterprises and research institutes all over the country on new drug research and development The contents of the speech ranged from pre pharmaceutical research, prescription and process development, technology transfer and amplification, to post market quality consistency evaluation, etc The speakers analyzed the key elements of new drug research and development from bioequivalence, dissolution, be, dissolution rate, crystal form, tablet pressing and other perspectives Among them, Chen Minhua, CEO of Suzhou Jingyun Pharmaceutical Technology Co., Ltd., and Zhou Lichun, assistant director of Beijing Institute of drug control, gave a thorough explanation of drug crystal and generic drugs, which are deeply popular Drug crystal shape is related to drug quality We need to be careful in choosing solid form Chen Minhua: CEO of Suzhou Jingyun Pharmaceutical Technology Co., Ltd., expert report title of national "thousand talents plan": concerns of drug crystal shape "Drug molecules - drug crystal forms - drugs, these three components are a kind of progressive relationship From this structure, it is not difficult to see that one of the key points of drug research and development is the drug crystal form" Dr Chen Minhua expressed his views in a flurry of words In his opinion, different crystal types of the same drug may directly affect the safety, effectiveness and quality controllability of the drug due to different appearance, solubility, melting point, dissolution, bioavailability and other aspects Due to the influence of different crystal forms, the physical and chemical properties of drugs are also different Through the case of ritonavir developed by Abbott, we emphasized the painful lessons brought to the enterprise by the improper crystal form selection Therefore, it will be of great benefit to the enterprise to select the most suitable solid form of drugs for development in drug research and development The importance of crystal form in drug research and development is self-evident In the same way, the crystal form also occupies the position of weight lifting in the preparation Dr Chen emphasized that the change of the crystal form of the API in the preparation will cause the change of the drug performance and the quality of the drug The deep understanding of the crystal form in the preparation process can predict the change of the crystal form of the API in the process, which can not only improve the drug quality, but also contribute to the drug declaration and patent protection Therefore, in order to strengthen the research and development of new drugs and improve the quality of drugs, we must pay attention to the selection and development of drug crystal It is necessary to pay attention to the evaluation of drug consistency for generic drugs to occupy the leading position in drug research and development Zhou Lichun: Assistant to the director of Beijing Institute of drug control, report title of the 9th and 10th National Pharmacopoeia Committee: "thinking on the evaluation of generic drugs consistency" compared with India, a big country of generic drugs, the development of generic drugs in China is in urgent need of catching up However, the current situation in China is that generic drugs occupy the main position in drug research and development, but the motivation is insufficient While encouraging the development of original drugs, more attention and research should be paid to generic drugs At this meeting, Zhou Lichun, assistant director of Beijing Institute of drug control, wrote a report on the consistency evaluation of generic drugs, which was thought deeply She believed that the development of generic drugs was hindered by the reasons such as the tiny position of generic drugs in the international market, the lack of trust of patients in domestic generic drugs, the sniffing of R & D personnel, and the difficulty of applying data In addition, she has doubts about the traditional consistency evaluation method of generic drugs, and believes that drug companies ignore be and clinical data self-examination, which is a disaster to protect people's lives and achieve win-win results for enterprises How to ensure the authenticity of be and clinical data? Zhou Lichun proposed to establish a real and credible clinical base, and paid attention to bioequivalence and quality consistency Based on the risk assessment of domestic consistency assessment methods, a series of risk avoidance schemes are put forward to make the country pay attention to the formulation of rules, the qualification examination of the third party organization, the fair supervision in the process of implementation, the establishment of a clear sampling system for test samples, the organization of experts to inspect the inspection institutions with legal qualifications, etc., and the products assessed to be consistent shall pass the quality assessment The quantity evaluation is divided into levels and explained, so as to achieve the true consistency of generic drugs.