Construction and exploration of pregnancy registries for medicine based on pharmaceutical service / 中华医院管理杂志

The pregnancy registry for medicine is a common method for risk evaluation for drug safety evaluation during pregnancy. The authors introduced the exploration and practice of the pregnancy drug registry mode based on pharmacy service in Women′s Hospital School of Medicine Zhejiang University. The registry of pregnancy medication with the drug consultation clinic as the fulcrum was managed by the pharmacist team in a homogenization way, and implemented according to the information process of consultation, pharmacy guidance and regular follow-up. In the consultation and follow-up work, the pharmacists established the consultation drug history through three data sources: independent report of the consultant, inquiry of pharmaceutical personnel and case sampling. The pharmacists designed and constructed information screening system, classified the consultation medicine history according to the pregnancy exposure of specific drugs. The prospective research method was designed to meet the characteristics of pregnancy medication. The study was carried out on the relationship between pregnancy exposure and birth defects of offspring. Relying on the improvement of standardization, refinement and information management level of pharmaceutical services, multi center cooperation will be strengthened in the future to carry out continuous research on pregnancy drug exposure registry and follow-up system.

Research on entity relation extraction of Chinese adverse drug reaction reports based on deep learning method / 中国药科大学学报

@#Adverse drug reaction(ADR)reports are acting as primary sources for post-marketing drug safety evaluation, which have important reference value for drug safety evaluation. In this article, bidirectional gated recurrent unit, a kind of deep learning method, was applied as the model for relation extraction of drugs and adverse reactions in free-text section of ADR descriptions in Chinese ADR reports, with attention as well as character embedding and word segmentation embedding added into the network. The experimental results showed that our model achieved good performance in the classification task of confirming the relationship of “Drug-ADR” pair(denial, likely, direct and post-therapy)in the ADR description, and the final model achieved an F-value of 87. 52%. The extracted information can assist in evaluating ADR reports and at the same time be utilized in tasks like statistical analysis of certain drugs and adverse events and ADR knowledge base construction to provide more research techniques for drug safety researches.

Main technical points of quarantine inspection of Beagle dogs used for drug GLP experiment / 中国比较医学杂志

The quarantine inspection and acceptance of laboratory animals is an important work, which can protect animals from pollution, occurrence and spread of diseases in the surounding area, and it is the key point to realize the quality standardization of laboratory animals.Beagle dogs are acknowledged widely as specialized laboratory dogs which is widely employed in experiments of drug safety evaluation because of the good genetic stability, environmental adaptability, disease resistance and consistency testing in the experiments.Establishment of standard operating procedures of beagle dog quarantine acceptance check for drug GLP organization tests, refining technical points, strengthen the technical training of quarantine officers, and efforts to improve the level of quarantine are needed to finally ensure the quality of laboratory animals.

Management of laboratory animals of new drug safety evaluation in GLP and AAALACi certification systems / 药物评价研究

With the global development of the research of medicine,more and more new drug safety evaluation institutions have been certified by Good Laboratory Practices (GLP) and Association for Assessment and Accreditation of Laboratory Animal Care International (AAALACi).Laboratory animal,which is the carrier of drug safety evaluation,its survival condition and animal welfare will directly effect the experimental results.Dealing with laboratory animal husbandry by scientific methods in two systems is the requirement to make sure the accuracy of experimental data of animal experiments.With the certification processes and practical experiences in two certification systems of Tianjin Institute of Pharmaceutical Research New Drug Evaluation Co.,Ltd.,also accompanied by experience exchangement with peers,the relationship of practices in two certification systems will be preliminarily discussed;Through strengthening the management of laboratory animal,it can help the institutions get the certificates.

Toxicological pathology in preclinical drug safety evaluation / 药物评价研究

Toxicological pathology is a morphological elucidatet ion of tissue damage caused by drug toxicity,including damage type,location,severity grade and prognosis.It provides objective and accurate data to support preclinical drug safety evaluation.Therefore,toxicological pathology plays an important role in drug safety evaluation,and the pathologic data or conclusion often determines the termination or continuation in many drug development projects.In this paper,the characteristic of toxicological pathology,standardized management,the development of new techniques including in situ hybridization,laser scanning cytometry and laser capture microdissection,and related problems in pathology are discussed briefly.