Latest ArticlesUbrogepant is a small-molecule oral potent calcitonin gene-related peptide receptor antagonist. It was approved by the U. S. FDA for the treatment of migraine on December 23, 2019. The approval of ubrogepant represents the first major innovation in the treatment of acute migraine in the past 25 years. This paper reviews the mechanism of action, pharmacokinetics, pharmacodynamics, clinical studies and safety evaluation of the drug.
The experience in the implementation of ICH M4Q in China was summarized, regarding the chemistry, manufacture & control (CMC) dossiers of chemical and biological drugs. Because ICH has developed many important quality and multidisciplinary guidelines after the implementation of ICH M4Q (R1) version, this article discussed the specific requirements and major problems of CTD format in combination with the current technical guidelines.
Clinical value is the core value of a drug on the market, and reflects the needs of medical staff and patients for drugs. By defining the characteristics of traditional Chinese medicine (TCM) and the needs of patients and clinic for medication, it is concluded that no matter what perspective is used to evaluate the clinical value of new TCM, the core content should be focused on the core clinical advantages of traditional Chinese medicine, such as advantage diseases of TCM treatment and patients' subjective feelings, the needs of patients for medical treatment, unmet clinical medication needs, and druggability. Comprehensive analysis of these four dimensions is also consistent with the characteristics of new TCM approved for marketing in the past five years.
In recent years, in vitro substitution experiments have become more and more important in male reproductive toxicology research, and the construction of a stable and reliable in vitro model is a strong guarantee for the research. With the development of biotechnology, in vitro testicular models have also transitioned from a single-layer cell culture to a new culture system that can simulate in vivo microenvironment better, such as microfluidic technology, three-dimensional culture technology, and organoids, and so on. These culture systems not only can simulate the blood-testis-barrier (BTB) or in vivo testicular microenvironment, but also extend duration of the culture system through co-cultivating of testicular tissues or germ cells. More importantly, sperm has also been successfully differentiated from germ cells of rodents, non-human primate and even human beings. These new culture systems have been successfully applied to the evaluation of testicular toxicants. However, there are some limitations for them, such as small number of differentiated sperm, low efficiency and difficulty in completely simulate the process of spermatogenesis in vivo, etc. This review mainly summarizes the advantages and disadvantages of these new testis culture systems in vitro and their future development directions.
Drug benefit-risk assessment (BRA) is an important part of pharmacovigilance. Multi-criteria decision analysis (MCDA) is the most widely used and most accepted quantitative method in the implementation of BRA. It is used by decision makers to weigh the benefits and risks of different drug treatment schemes. At present, MCDA model is widely used in drug BRA research, mainly involving chemical drugs, biological products and traditional Chinese medicine preparations, etc. Therefore, this article reviews the concept, implementation framework and application progress of MCDA model in the field of drug BRA, discusses its advantages and disadvantages, and looks forward to its development trend, so as to provide theoretical guidance for researchers to use MCDA model to carry out drug BRA research.
With the rapid development of biopharmaceutical industry, high-throughput miniature bioreactor systems have been widely used in recent years. The high-throughput miniature bioreactor system has the advantages of small size, high-throughput and good scalability, as well as the capability of on-line analysis and feedback control. At present, it is mainly applied in cell line selection, process optimization and process characterization. High-throughput technologies combining with experimental design can shorten the product development timelines significantly, improve the process robustness and product quality control, and accelerate the delivery of projects into clinical and commercial phase. This review mainly describes several common high-throughput miniature bioreactor systems and describes their applications in the biopharmaceutical industry, using Ambr system as an example.
Master protocol is a novel and more efficient design for clinical trial research than the traditional clinical trials. Usually a master protocol includes several sub-protocols which could investigate treatment effects of a single drug on several diseases or multiple drugs targeting a single disorder. This review compared master protocol with traditional trials in terms of the research design principle, application, and procedure flow as well as advantages and limitations. We also presented some examples of ongoing applications of master protocol designs including treatment of COVID-19 related illness. Finally, we discussed about potential implementation of master protocol in China especially under the COVID-19 pandemic with an evaluation on the relevant opportunities and challenges.
To compare and analyze the performance of commonly used evaluation methods for dissolution curves, and explore more suitable alternative method when f2 factor cannot be used due to highly variable dissolution data.
Taking bicyclol tablets as example, 20 batches of dissolution data were collected and compared using different evaluation methods, including model-independent methods, model-dependent difference test, and model-dependent equivalence test of the model parameters.
Among the several model-independent methods, the results of the f2-bootstrap method were closer to the f2 method than the multivariate statistic distance (MSD) method when the dissolution data had greater variation (>10%). The results of t-test and MSD for comparing the parameters of model-dependent method were significantly different with the f2 method. The tolerance intervals of each parameter obtained by using model parameters for the first time could be used as the equivalent interval of model parameters for evaluation of dissolution consistency in the future.
When the f2 method is not applicable, the f2-bootstrap method can be used as an alternative method. The newly proposed equivalence interval of the model parameters can make up for the deficiency of t-test, and better evaluate the dissolution curves from the view of quality consistency.
To optimize the dry granulation process of Shufeng Jiedu (SFJD) Capsules placebo based on the similarity of the dosage form characteristic attributes and visual characteristic attributes.
The technological parameters including horizontal speeds, rotate speed of roller and pressure rollers were screened by single factor experiment as well as L9(34) orthogonal experiment, taking particle formation rate, friability, value of chromatism and comprehensive in granulation process as indexes, and then, the optimum process was verified. On this basis, the physical properties of content particles were determined respectively, including angle of repose, loose and tap bulk density, moisture content and disintegration time, to evaluate the consistency of characteristic attributes of dosage form between the formed placebo and SFJD Capsules; and the chromatism value of the particles was determined to evaluate the consistency of visual characteristic attributes.
The optimized process parameters were as follows: horizontal speed 34 r·min-1, press roll speed 6 r·min-1 and press roll pressure 1.2×106 Pa. Through the process validation of three batches, it was shown that the particle forming rate of SFJD Capsules placebo prepared under the optimum process was between 73.67% and 75.87%, the friability was between 45.50% and 46.39%, the chromatism value was between 2.34 and 4.11. In the granule state, the dosage form characteristic properties as well as visual characteristic properties of placebo were consistent with those of the test preparation.
The optimized dry granulation preparation technology is feasible, reasonable and stable, which produces good flakes continuously and granules with color uniformity, suitable rigidity and good formability. And both the dosage form characteristic properties and visual characteristics properties of the placebo are consistent with the contents of SFJD Capsules.
To observe the influence of myrtol standardized (MS) on the Nrf2/HO-1 pathway in chronic obstructive pulmonary disease (COPD) rats, and explore the possible mechanism of MS in treating COPD.
Wistar rats were randomly divided into four groups: one was control group (CON), while the other three groups were exposed to cigarettes (CS) for 90 d to establish a COPD model firstly, then one group was given CS exposure (CSM) continuously, one group was quitted CS exposure (QSM), the other one group was quitted CS exposure and then given MS treatment (MSM), all the operations lasted for 30 d. After the modeling, the respiratory function, serum inflammatory factors (IL6, TNF-α), and lung tissue anti-oxidative stress indicators (T-SOD, MDA) were detected, HE staining of lung tissue was observed, and the expressions of Nrf2 and HO-1 in lung tissue by WB were analyzed.
The respiratory function of the CSM group decreased significantly (P<0.05), and the respiratory function of the QSM and MSM groups improved (P<0.05); the IL6 and TNF-α levels of the MSM group were significantly lower than those of the CSM group (P<0.05), and the T-SOD level increased (P<0.05), MDA decreased (P<0.05); HE staining showed emphysema-like forms in the lung tissues of the CSM group, MSM group could improve the abnormal structure of lung tissue. Meanwhile, the expressions of Nrf2 and HO-1 protein in the MSM group were relatively increased than the CSM and QSM groups (P<0.05), which was close to the CON group (P>0.05).
MS could significantly improve the respiratory function of COPD rats, reduce inflammation and infiltration, and weaken oxidative stress. Its internal mechanism is closely related to the activation of the Nrf2/HO-1 pathway.
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