OBJECTIVE: To investigate similarities and differences among bioequivalence approaches used by international regulatory authorities when reviewing applications for marketing new generic drug products which are systemically active and intended for oral administration. METHODS: The comparisons of these bioequivalence recommendations were performed and based on bioequivalence study designs, selection of bioequivalence subjects,dosage, selection of reference products, method of pharmacokinetic calculations and bioequivalence acceptance limits, bioequivalence waiver on multiple-strength products and and implementation of the Biopharmaceutics Classification System, which are issued by Australia, the European Medicines Association, Japan,the USA, and the World Health Organization. RESULTS: There were lots of differences were found in bioequivalence approaches among the regulatory authorities surveyed, although there are more similarities. CONCLUSION: Discussion of the similarities and differences among bioequivalence approaches used by international regulatory authorities would provide instructive and practical assists to the equivalence assessment of quality and curative effect for generic products in China.

OBJECTIVE: To investigate Guidance for Industry Bioequivalence Recommendations for specific products issued by FDA. METHOD: Combination with FDA and CFDA issued guidance related to Bioequivalence (up to May 20th, 2016), 185 FDA issued Guidance for Bioequivalence Recommendations for Specific Products were discussed, which are involved in the CFDA announced initial list of the equivalence assessment of quality and curative effect for generic products. RESULTS: Bioequivalence Recommendations for Specific Products issued by FDA is to further facilitate generic drug product availability and to assist generic pharmaceutical industry with identifying the most appropriate methodology for developing drugs and generating evidence needed to support ANDA approval or reassessment, as an extension and implement to the guideline involved in the aspect of bioequivalence. CONCLUSION: Bioequivalence Recommendations for Specific Products issued by FDA would provide instructive and practical assists to the equivalence assessment of quality and curative effect for generic products in China, since CFDA haven't released similar guidance on specific products yet.

OBJECTIVE: To investigate FDA issued lists and guidance on Bioequivalence Recommendations for Specific Products related with Narrow Therapeutic Index Drugs.METHODS: FDA issued lists and Bioequivalence Recommendations for Specific Products related with Narrow Therapeutic Index Drugs was investigated in multiple aspects, including detailed drugs lists, bioequivalence study designs, selection of bioequivalence subjects,analytes to measure,bioequivalence waiver, selection of reference products.RESULTS: Keeping updated lists and Bioequivalence Recommendations for Specific Products relative with Narrow Therapeutic Index Issued by FDA are to further facilitate generic drug product availability and to assist generic pharmaceutical industry with identifying the most appropriate methodology for developing drugs and generating evidence needed to support ANDA approval or reassessment.CONCLUSION: Narrow therapeutic index list and Bioequivalence Recommendations for Specific Products issued by FDA would provide instructive and practical assists to the equivalence assessment of quality and curative effect for generic products in China, since CFDA have not released similar list and guidance on specific narrow therapeutic index.

Objective To know the expression of 47 kD protein of orientia tsutsugamushi(Ot) Karp strain and test its immunogenicity and antigenicity.Methods Forty-seven kD protein gene that code the whole mat peptide was amplified from the genomic DNA of Ot.Karp strain by PCR and constructed to a recombinant plasmid pGEX-47.The E. coli cells BL21 were transformed with pGEX-47,then the transformants were induced to express the recombinant 47 kD protein by IPTG. The antigenicity and immunogeni-(city) were identified by Dot Blot method and the experiment of immunizing mice respectively.Results 1. The PCR product of 47 kD protein gene of Ot.Karp strain was obtained and its sequence was the same as the published 47 kD protein gene.2. The E.coli expression plasmid pGEX-47 constructed was identified containing the 47 kD protein gene fragment by restrication analysis and PCR identification,and an expression band about 47 kD was detected by SDS-PAGE of the purified product from GST-fusson protein expressed by pGEX-47. 3.Dot Blot analysis and the experiment of immunizing mice testified its antigenicity and immunogenicity.Conclusions The 47 kD protein gene of Ot Karp strain is amplified that code the whole mat peptide, which can be expressed in prokaryotic cells and the expressed protein has antigenicity and immunogenicity.

Objectives To provide reference for the improve of health care system and healthcare insurance con-trolling method, through researching on the value-based healthcare paying system in South Korea. Methods The basic characteristics of the Korean health care system was researched, Specifically, its reform experiences of value-based health insurance review and assessment paying system,which government took. Results South Korea’s health care pay-ing system had achieved both good social and policy effects. Conclusions Value-based health care paying system is the main reason for the reducing of health care expenditures and making of scientific health policy.

Objective To explore the efficacy of percutaneous intratumoral injection of mixed emulsion with hot lipiodol and pira-rubicin for treatment of liver metastases lack of blood supply.Methods 12 patients with liver metastases,confirmed by the clinical and pathological examination,were treated by intratumoral injection of mixed emulsion with heating lipiodol and pirarubicin using 21G biliary needle under CT guidance.The adverse events were recorded and the treatment efficacy was also assessed according to the imaging findings.Results 8 patients achieved a partial remission of lesions,and 3 ones had stable condition.No serious adverse reactions occurred.Conclusion It is effective,simple,convenient and safe for treatment of liver metastases lack of blood supply with percutaneous intratumoral injection of emulsion with hot lipiodol and pirarubicin.

Objective To investigate the change of transmembrane potential during Noradrenaline's early preconditioning phase and probe the mechanism of action.Methods Primary culture myocardial cell of neonate rat were divided into three groups at random.GroupⅠ is control group,Group Ⅱis treatment group by hypoxia,Group Ⅲ is treatment group by NA.Group Ⅰ didn't give any drug to culture for 40minutes;Group Ⅱ treated for 40minutes by hypoxia,Group Ⅲ exposed to Noradrenaline(0.2?g/ml)for 10 minutes then treated with hypoxia for 40 minutes.The fluorescence intensity of rhodamine-123 marked mitochondria were detected by flow cytometry.Results The fluorescence intensity of three Group were test by analysis of variance(F=461.3,P

Nutrition support is an important part of comprehensive treatment strategy for critically ill patients. After long-term scientific research and practice, great progress has been made in theoretical cognition and clinical application. The authors summarize the metabolic charac-teristics and nutritional support strategies of critically ill patients based on their pathophysiological changes, in order to provide rational and theoretical basis for reasonable and effective nutrition support strategy in critically ill patients.

Objective To investigate the methods and effects of posterior fixation and fusion in treatment of complete thoracolumbar fracture and dislocation.Methods The study enrolled 8 cases of complete thoracolumbar fracture and dislocation treated by posterior fixation and fusion with pedicle screwrod system between January 2006 and December 2012.There were 7 males and 1 female,at mean age of 31.9 years (range,19-49 years).Mean time interval between injury and surgery was 8.1 days (range,4-12 days).Fracture-dislocation classification was AO type C,Denis three-column injury,and Meyerding grade V.According to American Spinal Injury Association (ASIA),there 5 cases at grades A,1 at grade B,1 at grade C 1 at grade E.Fracture-dislocation segments included T5-T6 in 1 case,T12-L1 in 3,L1-L2 in 2,L3-L4 in 1 and L4-L5 in 1.Results Mean duration of surgery was 220.6 minutes (range,135-335 minutes) and mean intraoperative blood loss was 1 150 ml (range,500-2 400 ml).Seven cases sustained dural laceration during the operation,which were sutured or covered with autologous fat grafts,but 3 of them were subjected to cerebrospinal fluid leakage and healed after conservative therapy.Anatomic reduction was achieved in 6 cases,partial reduction in 1 and non-reduction in 1.Mean Cobb angle improved from 29.3 ° (range,8 °-51 °) preoperatively to 1.9 ° (range,-5°-10 °) postoperatively.After a mean follow-up of 39.3 months (range,2-76 months),2 cases were recovered from preoperative ASIA grade A and B to C respectively and 6 cases (4 A,1 C,1 E) revealed no significant improvement.There was no implant loosening or breakage.One case was died of lung-related complications at postoperative 4 years.One case sustained lumbar deep infection at postoperative 3 weeks and managed by debridement,irrigation,drainage and implant retention.Conclusion Posterior fixation and fusion is the general treatment principle for complete thoracolumbar fracture and dislocation,but the degree of reduction depends on severity of the injured spinal cord.

Objective To analyze the prognostic factors associated with three-year survival outcome in patients with serous ovarian adenocarcinoma by classification tree.Methods Retrospectively we analyzed 81 cases with serous ovarian adenocarcinoma who had 3-year clinical outcomes and were hospitalized in People's Hospital from Jan 1991 to Dec 2003 by classification and regression trees(CART)software.Establish the classification tree.Results Among the factors that were associated with the 3-year survival rate,age was the most important factor,other factors in turn were International Federation of Gynecology and Obstetrics(FIGO)stage,lymphoid metastasis,residual size after operation,chemotherapy and pathologic grade.By substitution variable analysis,it was demonstrated that there was cross interaction between age and residual size as well as age and chemotherapy.Conclusion Age,FIGO stage,lymphoid metastasis,residual size after operation,chemotherapy and pathologic grade are important prognostic factors related with three-year survival probability of serous ovarian adenocarcinoma patients.