OBJECTIVE: It is found that there are differences in quality of drugs on the market. In order to get safe, effective and rational drug use, we suggest that the evaluation of drugs be mandatory. METHODS: The drugs have been evaluated from angles of clinic effectiveness, bioequivalence, pharmacoeconomics and pharmaceutics. RESULTS: Different evaluating ways showed different characteristies. CONCLUSION: The quality control by pharmaceutical methods is one of the easiest and the most economic ways to do.

OBJECTIVE:To provide references for drug administrator in coping with the challenge of drug shortage and the promotion of rational drug use. METHODS: With American Society of Hospital Pharmacists Guidelines on Managing Drug Shortages as references,the feasible management strategies for drug shortage in China were put forward based on the reality of our country and our experience in the practice of drug shortage management. RESULTS & CONCLUSIONS: It is advisable to draw experiences from U.S. Food and Drug Administration to tackle the problem of the shortage of essential drugs through the co-efforts of Ministry of Public Health,State Food and Drug Administration and Stage Development and Reform Committee and develop contingency planning strategy in health care organization to deal with the shortages of certain drugs and reduce potential clinical safety hazard induced by drug shortages.

OBJECTIVE:To compare the physical chemistry properties of copying(A) and original(B) aluminium phosphate gel METHODS:We examined the character,antacid activity,isolating capacity against H+ ions and viscosity in different pH values of two products RESULTS:Product A was not better than product B in the Character,antacid activity,isolating capacity against H+ ions and viscosity;The antacid activity of two preparations not influenced obviously by the food with low concentration;Two preparations all had difference physical chemistry properties in batches CONCLUSION:Product B was better than A in comparison of the physical chemistry properties

OBJECTIVE　To develop an HPLC method for the determination of floxuridine in human serum.METHODS　With metronidazole as the internal standard,200 μL of serum was extracted by n-propyl alcohol/methyl t-butyl ether in a two-step extraction.The organic layer was evaporated under nitrogen stream and the residual was reconstituted with the mobile plase.A Shim-Pack CLC-ODS column was selected and the mobile phase was consisted of acetonitrile-phosphate buffer-water (75∶100∶900) at a flow rate of 0.6 mL*min-1.The detection wavelength was 268 nm.RESULTS　A linearitywas obtained from 0.005 to 0.5 mg*L-1 of floxuridine in serum with a good correlation coefficient (r=0.9999,n=8).The intra-run and inter-run coefficients of variation were less than 4.09%.The mean recoveries were 103.00%,107.00% and 100.88% for the low,middle and high concentrations of check samples,respectively.The limit of detection was 0.001 mg*L-1.CONCLUSION　The method was sensitive,specific and simple.It is suitable for clinical pharmacokinetic study.

OBJECTIVE: To provide references Chinese medical institutions about the composing of formulary. METHODS: We reviewed online document and literatures, briefly introduced the concept, structure and contents of formulary as well as the management process of the formulary system in foreign countries. RESULTS & CONCLUSIONS: Formulary can provide effective information in the health-care settings, and the information related to formulary and formulary system abroad serves as a mirror for the composing and enforcing of formulary in China.

OBJECTIVE:To compare the quality of domperidone tablets produced by 3 different factories METHODS:The quality of different products was investigated according to the standards of Ministry of Public Health and manufacture factories,including dissolubility,uniformity of dosage units,related substances and seals of blister packaging RESULTS:In 3 batches of products manufactured by Y,W and L,the contents of domperidone were 98 23%～99 74%,96 92%～98 31% and 97 42%～98 72%,and content uniformity A+1 8S was 2 11～3 38,3 97～5 25 and 5 49～7 47 respectively,which were in keeping with the Chinese pharmacopoeia;impurity R061668 was not found,and contents of impurity R052211 were 0 004%～0 024%,0 029%～0 072% and 0 003%～0 056%;the total impurity substances were 0 030%～0 095%,0 102%～0 128% and 0 232%～0 489%;the dissolubity(45min) was 95 09%～95 77%,91 25%～96 43% and 95 48%～96 58% respectively In experimental condition,no leakage was found from blister package of Y and W products,however,the leak rate of L product reached more than 38% CONCLUSION:According to this survey,the quality of product Y is the best,W is better

OBJECTIVE　To study the bioequivalence of methylprednisolone (MP) tablets in healthy volunteers.METHOD　A rapid and sensitive RP-HPLC assay was modified for the determination of the drug levels in plasma. In a randomized two-way crossover design, 40 mg single dose po domestic (B) and imported (A, MedrolTM) MP tablets, respectively, were given to 18 male healthy volunteers. The parameters were estimated by non-compartment model with a statistic analysis of ANOVA and two one-side t-test.RESULTS　The tmax,cmax,t1/2 and AUC0～∞ of tablet-B and-A were (1.9±0.5) h and (2.1±0.5) h, (597.6±119.8 ) ng*mL-1 and (572.6±121.7) ng*mL-1,(2.2±0.4) h and (2.3±0.4) h,(2528.4±558.8) h*ng*mL-1 and (2571.2±647.4) h*ng*mL-1,respectively.The mean relative bioavailability of the tablet-B vs A was 99.62%. There was no significant difference between the two products.CONCLUSION　The results suggested that these two products were bioequivalent.

Clinical decision-making has been perceived as a primary cognitive activity for clinicians in daily practice,which based on the process of choosing between alternatives or options for patients.A single clinical decision might affect one patient's health outcomes,while the sum of clinical decisions made by all clinicians would play a decisive role in the allocation and utilization of health resources.Several dimensions should be taken into consideration when making clinical decisions,such as scientificity,clinical experience,economical status,medical humanities and government administration.In addition,clinical decision-making behavior should be administrated and guided by government,from the following seven aspects,so as to avoid "scientism" or " commercial alienation" phenomenon:national guidelines and standards development,academic standardization,expertise offering,medical training with human factors as well as legal punishment,medical knowledge accessibility,reimbursement restriction,and application of artificial intelligence.

A proportion of patients with locally advanced rectal cancer will achieve clinical complete response (cCR) or pathologic complete response (pCR) after neoadjuvant chemoradiotherapy. With the proposal of the concept of total neoadjuvant therapy (TNT), higher complete response rates will be observed. The management of patients with cCR has long been an issue of controversy and is attractive for clinical trials. A "watch and wait" strategy for patients with cCR has been put forward by some scholars. A non-operative approach can preserve the organfunction and avoid complications after radical surgery. The safety and feasibility of a "watch and wait" strategy have been established in several non-randomized controlled studies. There is no consensus on how to make an optimal decision for patients with cCR. For example, it is only observed in partial patients that cCR is consistent with pCR and the molecular biomarkers for predicting pCR are suboptimal. Besides, cCR is inconsistently defined and surveillance recommendations varies. Furthermore, there are insufficient high-level evidence for the "watch and wait" strategy. For patients with good response after chemoradiotherapy, local excision is an attractive alternative to total mesorectal excision, however with uncertain indications and challenged oncological safety. For patients with cCR, we implement the therapeutic principles of goal-orientation, layered treatment and the whole process management.

Objective Long-chain triacylglycerol (LCT) by three producers,each mixed with the same medium-chain triacylglycerol (MCT),were compared with the brand MCT/LCT in causing focal necrosis of hepatocytes in beagle dogs (a bioequivalence evaluation).Methods 21 beagle dogs (male,0.7-1.5 years old,10-15 kg) were used in this study.According to the sources of the LCT,the animals were divided into Group A (LCT made in China),Group B (LCT made in Japan),Group C (LCT made in Germany),and the control group (the brand 10％ MCT/LCT).Central venous port was placed via the lumber vein of the animals under general anesthesia.After 2 weeks of rehabilitation,MCT/LCT was administered through this port for 28 days at 9 g/ (kg · d) [while the routine dose used clinically was 1 g/ (kg · d)].The laboratory indexes and the pathomorphism of the liver and kidney were studied single blindly.Results Laboratory tests,including liver and kidney function,blood coagulation function and lipid metabolism,did not identify differences among emulsions with different sources of LCT.Liver biopsy at day 28 showed no focal necrosis in Group C and the control group;there was minor damage in Group B;and Group A had obvious liver necrosis.and the pathological findings of other organs are similar.No significant difference was observed in biopsies of other organs.Conclusions Emulsions with different sources of LCT varied in their damage to the liver.Generics with LCT of higher quality were equivalent to the brand MCT/LCT in terms of safety.