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Liu B.-L.,Center for Drug Evaluation
Chinese Journal of New Drugs | Year: 2016

According to regulations and guidance documents, this paper introduces mainly classification of efficacy endpoints in a clinical trial of the new drug, and classification of clinical outcomes of a disease and health condition. The definition, concept, characteristics of different clinical efficacy endpoints and clinical outcomes of diseases are also introduced, such as clinical outcomes, clinical endpoints, surrogate endpoints, intermediate endpoints, primary endpoints, secondary endpoints, biomarker, PRO, ClinRO, ObsRO, PerfO and so on. © 2016, Chinese Journal of New Drugs Co. Ltd. All right reserved. Source


Jiang D.-Z.,Center for Drug Evaluation
Chinese Journal of New Drugs | Year: 2016

Based on analyzing the drug guidelines published by CFDA(CDE), FDA(CDER) and EMA, the author points out some differences between those guidelines and the misunderstandings caused by those differences. Combined the actural work experience, the author gives some comments on the solution to the problems. Source


Zhang N.,Center for Drug Evaluation
Chinese Journal of New Drugs | Year: 2012

As the CMC development and research of innovative drugs have the characteristics of uncertainty and phased approach, a lot of CMC changes took place during drug development. Here, the common reasons for change, review focus on change, main change types and technical requirements for each change type were summarized. Furthermore, typical cases were used to elaborate the concepts above. Source


Chen Z.,Center for Drug Evaluation
Chinese Journal of New Drugs | Year: 2014

In the past 10 years, technical requirements with respect to chemistry, manufacturing & control (CMC) for registration of chemical drugs have been established systematically in China. At present, CMC technical requirements are being improved based on science and risk principles in order to make these requirements more in line with the rules of drug research & development as well as international standards. In this article, we reviewed briefly the progress history of CMC technical requirements for registration of chemical drugs in China, and summarized the current basic considerations for improving CMC technical requirements, i.e. systematic quality control, phases of CMC development and linkage in quality. Moreover, we put forward the developing prospects of CMC technical requirements in China. Source


Tao Q.,Sun Yat Sen University | Chen J.-M.,Sun Yat Sen University | Ma L.,Center for Drug Evaluation | Lu T.-B.,Sun Yat Sen University
Crystal Growth and Design | Year: 2012

One phenazopyridine monohydrate (1•H 2O), one cocrystal of phenazopyridine with phthalimide (2), and three salts of phenazopyridine with benzoic acid (3), 4-hydroxyphenylacetic acid (4), and scaaharin (5) were synthesized, and their structures were determined by single crystal X-ray diffraction. The results of dissolution experiments indicate that the solubility of phenazopyridine can be enhanced after the formations of cocrystal and salts, in which the apparent solubility value of 5is approximately 9 times as large as that of phenazopyridine in water, and the apparent solubility value of 4 is approximately 10 times as large as that of phenazopyridine hydrochloride (1•HCl) in 0.1 M HCl aqueous solution. The results of the stability study demonstrate that 2-5 are less hygroscopic than 1•H 2O and 1•HCl at both 85% and 98% RH. © 2012 American Chemical Society. Source

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