ArchiveWith the increasing number of new drugs on the market, the risk of drug safety also increases. The establishment of pharmacovigilance system is proposed in the Drug Administration Law, which is of great significance to the future research and development of new drugs and drug supervision. Pharmacovigilance system includes management and technical activities. The implementation of China's pharmacovigilance system meets the requirements of new regulations and systems. This article discusses the concept and scope of the implementation of China's future pharmacovigilance system, the key points of the transformation from the adverse reaction monitoring and reporting system to the pharmacovigilance system, and the obligations and responsibilities of all parties in the pharmacovigilance system.
This article reviews the updates and amendments of viral vaccines in volume Ⅲ of the Chinese Pharmacopoeia (ChP) 2020 edition, including a brief introduction to the newly added, updated and revised monography and general chapter and analysis of the features and reasons, and gives suggestions for the next step work. It is beneficial for better understanding and implementation of the Chinese Pharmacopoeia 2020.
mRNA-based drug has already become a focus as a potential new type of drug in recent years. With the rapidly evolving technologies, mRNA has been widely applied in various areas of clinical research, such as immune disease, oncological disease, infectious disease, and congenital metabolic disorder. Since the outbreak of COVID-19, there has been a great leap in mRNA vaccine development, forecasting that much more mRNA medicines will enter the market in the near future. In order to meet industrial requirements, this article provides an overview of the product profiles of mRNA-based drugs and their industrial landscape, and further discusses the key considerations in the manufacturing of such medicines.
Adaptive licensing pathway is one of the most characteristic rapid marketing authorization routes of new drugs in EU. This path is based on the conditional marketing authorization path, but is different from the traditional marketing approval path. Its main feature is to use prospective iterative evidences to bring drugs with potential clinical value to the market as soon as possible. This paper studied the application standards, entry procedures, approval model, operation mechanism and implementation experience of the adaptive licensing pathway, thus to provide valuable references for the exploration and construction of adaptive licensing pathway of new drug registration in China.
Discovering and tapping technological opportunities provide important references for understanding industry R&D trends, making innovative decisions and strategic layouts. This paper constructed a model for systematically identifying technical opportunities in the field of traditional Chinese medicine antidepressants. First, the incoPat patent database was used to download the patent data in the field of traditional Chinese medicine antidepressants, and the data was put under five major technical topics. Secondly, the technical opportunities in the field of traditional Chinese medicine antidepressants were identified and analyzed from the three dimensions of innovation subject, region and market level separately. Finally five technological topics with competitive advantages and cooperation possibility unearth innovative entities were discovered, R&D hotspots and regional cooperation opportunities in various countries and provinces in China were identified, and patents with high market value and their technical contents were screened out. This study not only provides suggestions for companies to seize technological opportunities and seek technological innovation breakthroughs in the field of traditional Chinese medicine antidepressants, but also provides a basis for the government to formulate technological innovation incentive policies.
Ubrogepant 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.
To evaluate the detection performance of one kind of imported nitrofurantoin susceptibility test disk for antimicrobial susceptibility test by disk diffusion method.
A total of 118 strains of pathogenic bacteria were collected from a Class A tertiary comprehensive hospital in Beijing from 2016 to 2017, including 61 isolates of Enterobacterales, 48 isolates of Staphylococcus spp. and 9 isolates of Enterococcus spp. Antimicrobial susceptibility test was performed following Clinical and Laboratory Standards Institute (CLSI) documents M100ED30, using disk diffusion method. The differences of susceptibility between domestic disks and imported disks against 118 bacteria strains were detected according to the breakpoints described in CLSI documents M100ED30. The rate of categorical agreement (CA) of susceptibility conducted by the two kinds of disks was calculated.
Among the 118 isolates, 73, 4 and 41 were categorized as susceptible (S), intermediate (I), and resistant (R) to nitrofurantoin, respectively. The rate of categorical agreement of susceptibility to nitrofurantoin using imported disks and domestic disks was 100%.
The results of susceptibility test using imported nitrofurantoin disks are reliable, and consistent with the results by domestic nitrofurantoin disks. Imported nitrofurantoin disk can meet the requirements of clinical laboratory. The test results will provide direct reference data for clinical application for nitrofurantoin in infectious diseases.
To analyze the occurrence and clinical characteristics of skin adverse reactions caused by vemurafenib, and provide reference for clinical safe drug use.
The literatures about skin adverse reactions of vemurafenib were retrieved from Web of Science, PubMed, CNKI, VIP database and Wanfang data, and then analyzed and summarized.
A total of 41 cases of ADRs induced by vemurafenib were reported. Most of them aged from 41 to 70 years old (n=25, 61.0%). Most of them occurred within 15 d after medication (n=22, 53.7%). The main clinical manifestations of skin system ADRs induced by vemurafenib were lipiditis (12 cases, 29.3%), leukocytoclastic vasculitis (n=6, 14.6%), granulomatous dermatitis (n=5, 12.2%), photosensitive dermatitis (n=4, 9.8%), radioactive dermatitis (n=3, 7.3%), and hyperkeratosis (n=3, 7.3%). Thirty-four cases were cured or improved after ADRs, of whom 27 cases (65.9%) resumed vemurafenib treatment, and 7 cases discontinued, including granulomatous dermatitis (2 cases), toxic epidermal necrolysis (1 case), cutaneous vasculitis (2 cases), and photosensitive dermatitis (2 cases). Among the 27 patients who restarted vemurafenib treatment, 21 cases maintained the original dose, 5 cases reduced the original dose to 3/4, 1 case reduced the original dose by half, and ADRs occurred again in 9 patients.
Drug monitoring should be strengthened during the clinical use of vemurafenib, especially for the occurrence of ADR within 15 d after drug administration, potential ADRs should be detected in time, appropriate prevention and treatment measures should be taken, and the treatment risk after resumption of treatment should be carefully evaluated.
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