ABSTRACT
The rapid changes in the research and development environment of new anti-tumor drugs in China have brought various challenges to drug innovation. How to explore the clinical advantages of new drugs in the early phase, and design scientific, reasonable and efficient pivotal clinical trials for drug registration accordingly, is one of the key challenges. This article takes innovative new drugs for hematological malignancies as an example, comprehensively elaborates the considerations on the timing for entering the pivotal clinical trial and the key elements of the trial design from the perspective of clinical reviewers.
ABSTRACT
Efficient management and evaluation is the primary responsibility of drug regulatory authorities in various countries, whose management services are mainly delivered in accordance with the Good Review Practices(GRPs) and ISO 9001 quality management system. In 2015, Opinions on Reforming the Evaluation and Approval System of Drugs and Medical Devices included the perfection of quality control review system as the content of reform in drug review and approval. On this basis, the traditional Chinese medicine(TCM) review authority has shortened the review time, strengthened the communication, offered technical guidelines, designed the review template with guiding significance, and carried out diversified training and performance evaluation, to continuously strengthen the standardization of TCM review and approval and effectively guarantee the scientificity and consistency of new TCMs. However, the current quality management system for TCM review is not yet mature. It is recommended to employ ISO 9001 quality management system to manage the review work, utilize the GRP for better management of the archive files in the review process, and use quality evaluation indicators to improve the review quality management, thereby further perfecting the TCM review management system.
Subject(s)
Drugs, Chinese Herbal , Medicine, Chinese Traditional , Quality Control , Reference StandardsABSTRACT
The research and development progress and all relevant technical requirements about new Chinese medicines since the release of Provisions for Drug Registration(2007 Version) were reviewed and summarized in this paper. To promote the healthy deve-lopment of regulatory agencies and the traditional Chinese medicine industry, the author conducted a comprehensive analysis on the advantages and disadvantages of the current technical requirements for new Chinese medicines and some typical cases in technical review, and put forward some constructive suggestions on the philosophies of traditional Chinese medicine review and the resolution of some technical disputes.
Subject(s)
Drugs, Chinese Herbal , Medicine, Chinese Traditional , ResearchABSTRACT
Based on the history of pharmacovigilance activities in Japan, the expectations for MIHARI Project from the perspective of academia are discussed. First, drug safety and risk-benefit related activities should be enhanced from the early stage of drug development and/or in the regulatory approval stage. Second, more collaboration with regulatory authorities and academia should be promoted. Third, knowledge obtained from MIHARI Project should be published timely and continuously which contribute to related safety activities conducted by other than regulators.
ABSTRACT
@#Alzheimer's disease (AD) is the general neurodegenerative disease in the elderly. Alterations of microtubule associated protein tau are closely related to the onset and progression of AD. The role of tau protein in the development of AD has been a focus in the current study of AD, with an emphasis on the identification of compounds that inhibit tau protein phosphorylation and aggregate, and accelerate tau protein depolymerization. The current research status of tau protein as target of AD preventive and therapeutic drug was also reviewed.
ABSTRACT
@#Parkinson's disease (PD) is one of the most prevalent neurodegenerative movement disorder in human being, characterized by progressive degeneration and lost of dopamine (DA)-producing neurons in the substantia nigra pars compacta (SNpc),causing low level of DA in the nigrostriatal pathway, eventually leading to motor dysfunctions including tremor, rigidity, bradykinesia,and postural instability.The pathology of PD is complex and the etiology remains poorly understood. In recent years,inflammation has been suggested to be involved in the occurrence and development of PD, by activation of microglia and overexpression of the inflammatory factors. And anti-inflammatory drugs has been developed to delay or prevent the progressive course of PD, becoming a new hotspot in treatment of PD. In this review, the latest progresses on the inflammatory mechanisms and anti-inflammatory treatments of PD was introduced.
ABSTRACT
@#Atherosclerosis is the common basic pathophysiology progresses of acute cardiovascular and cerebrovascular diseases. Atherosclerotic plaque rupture and consequently thrombosis are the major cause of mobility and mortality in atherosclerosis, and treatment aimed at stabilizing vulnerable plaques is of great clinical importance. However, an ideal drug for stabilizing vulnerable plaques is still lacking. Although Statins are considered as the most potent drugs for stabilizing plaques, their side effects are serious. Traditional Chinese medicine have multi-targets and less side effect, it might be the potential candidate for atherosclerosis treatment. This article reviewed the latest progresses on the stabilizing vulnerable plaques treatments.
ABSTRACT
@#Neural stem cells (NSCs), which will proliferate and differentiate into neurons and glial cells under certain conditions, involved in the repair of neurological function. This process is called neurogenesis. Focal cerebral ischemia-reperfusion injury is one of the most common diseases, which can induce the neurological functional deficits. It is significant to study the response and regulation of NSCs after focal cerebral ischemia-reperfusion injury. In this article, we reviewed the characteristics, molecular mechanisms, putative endogenous mediators and exogenous stimulators of neurogenesis in adult brain following ischemic injury, and response and regulation of drug in ischemic injury following neurogenesis.
ABSTRACT
@#Cerebral ischemia-reperfusion results in damage on neuron, leading to genes and proteins related to apoptosis activation. At the same time, generous cytokines released after cerebral ischemia-reperfusion can induce the apoptosis of the neuron. Many current studies have showed that the major damage mechanisms on apoptosis of the neuron are mitochondrion impairment, calcium overload, increased levels of oxygen radicals and so on. The advance research on the mechanism contributes to explore new neuroprotective drugs, and further identify the target and therapeutic effect of drug treatment.
ABSTRACT
@#Cerebral ischemia-reperfusion Results in breakdown on construction and function of blood brain barrier, leading to hemorrhage transformation and brain edema. At the same time, generous cytokines and chemokines released after cerebral ischemia-reperfusion can regulate the opening of the blood brain barrier. Many current studies showed that the major damage mechanisms on blood brain barrier are inflammatory infiltration, proteolysis, opening aquaporin and so on. The deep research on the mechanism contributes to explore new neuroprotective drugs, and further identify the target and therapeutic effect of drug treatment.
ABSTRACT
@#Cerebral ischemia-reperfusion Results in breakdown on construction and function of blood brain barrier, leading to hemorrhage transformation and brain edema. At the same time, generous cytokines and chemokines released after cerebral ischemia-reperfusion can regulate the opening of the blood brain barrier. Many current studies showed that the major damage mechanisms on blood brain barrier are inflammatory infiltration, proteolysis, opening aquaporin and so on. The deep research on the mechanism contributes to explore new neuroprotective drugs, and further identify the target and therapeutic effect of drug treatment.
ABSTRACT
OBJECTIVE: To provide references for optimizing the selection of medical insurance drugs and drug review in China.METHODS: The Canadian common drug reviewers' basic duties and the Canadian common drug review process were introduced,and the existing problems in drug review and the countermeasures were analyzed.RESULTS & CONCLUSIONS: In view of the problems occurred in Canadian drug review such as redundant delay and tedious,lack of transparence and job responsibility system and so on,the corresponding measures had been taken such as defining drug review time,helding long range e-meeting,and establishing public committee etc.Chinese common drug review should draw experiences from the Canadian drug review to explore a more economical,timely and transparent practice in Chinese medical insurance drug selection and drug review.
ABSTRACT
@#There is a lot of drug to cure the osteoporosis.The drug effect feature is different,and clinicle choice and application is complicated,too.This paper will review the advancement of drugs and their mechanism for treating osteoporosis,including calcium and vitamin-D,estrogen,selective estrogen receptor modulators,caicitonin,bisphosphonates,parathormone and fluoride etc.