Overviews and analysis of the U.S. FDA′s new approvals in the 2016 second half year / 国际药学研究杂志

In the second half of 2016,the U.S. Food and Drug Administration(FDA)approved 7 new molecular entities and 3 new Biologic License Application(BLA), the lowest number in recent years. According to the prescription information for profes-sionals,this article introduced the description,mechanism of action and clinical studies and briefly describes the boxed warning,indi-cations and usage,dosage and administration,dosage form and strength,contraindications,warning and precautions,adverse reac-tions,drug interaction and the use in the special population. In addition,the first and critical events in the history of new drug develop-ment and reaserch were emphasized.

Overviews and analysis of the U.S. FDA′s new approvals in the first half year of 2016 / 国际药学研究杂志

In the first half year of 2016,the U.S. food and drug administration(FDA)approved 9 new molecular entities and 8 new biologic license applications. According to the prescription information for professionals,this article introduces the description, mechanism of action and clinical studies;briefly describes the box warning,indications and usage,dosage and administration,dos?age form and strength,contraindications,warning and precautions,adverse reactions,drug interaction and use in special population of these new drugs. In addition,the first and critical events in the history of new drug development and reaserch are emphasized.

New drugs approved by the U.S. FDA(2007-2016):a review / 国际药学研究杂志

The introductions of the new drugs approved by the U.S. FDA have been published in the“Journal of International Pharmaceutical Research”for ten years. However,new problems might emerge with the increasing clinical practice and the cumulative number of patients being treated,such as the indications and purposes change,supplement of the modified efficacy,clinical data and the important new indications,constant improvement of the dosage,form and mode of administration,and the emergence of new,seri?ous and even fatal adverse reactions urge the supplements of contraindications,warnings and precautions,or even the black box warn?ings. In brief,6 entries of the introductions all may be modified,supplemented or canceled. More importantly,ten years of general analyses also find some prominent events,such as the amount of new molecular entity(NME)and new biological products come to an obvious peak in 2015. With regard to this,this paper reviewed the prominent historical events happened in the ten years in order to provide guidance and reference for new drug research and development.

Technique improvement on mouse model of biliogenic severe acute pancreatitis / 中华危重病急救医学

Objective To establish a mouse model of biliogenic severe acute pancreatitis (SAP) by using a self-made device for retrograde injection of sodium taurocholate into common bile duct,and to investigate the improvement of the device on retrograde injection of sodium taurocholate into common bile duct and its safety.Methods Thirty-six adult male ICR mice were randomly divided into biliogenic SAP model group and sham group,with 18 mice in each group.A 40 U disposable insulin syringe,a 200 μL tips and a 25 μL micro-syringer were used as basic materials for making the mouse common bile duct injection device [National Utility Model Patent (ZL 2014 2 0694365.4)].In model group,3.5％ sodium taurocholate (1 mL/kg) was injected retrogradely into the common bile duct of mice,whilst in sham group,the mice underwent the injection of equal amount of normal saline instead.Six mice in each group were sacrificed at 6,24 and 48 hours after operation,and the abdominal aortic blood was collected.Serum amylase (AMY),alanine aminotransferase (ALT),creatine kinase-MB (CK-MB),serum creatinine (SCr),oxygenation index (PaO2/FiO2) as well as serum Ca2+ were.determined.Pathological change in pancreas was observed under conventional light microscopy after hematoxylin and eosiu (HE) staining,and the impairment was evaluated by a widely used score system.Results The injection device was easily placed into mouse common bile duct under macroscopic observation.Six hours after operation,the levels of serum AMY,ALT and SCr in model group were significantly higher than those in sham group,and peaked at 24 hours,and they slightly decreased at 48 hours,which were still significantly higher than those of the sham group [24-hour AMY (U/L):7 325 ± 1 154 vs.1 737 ± 197,24-hour ALT (U/L):176.0±5.0 vs.38.3 ± 2.0,24-hour SCr (tmol/L):46.3 ± 1.5 vs.17.8 ±0.6,all P ＜ 0.01].The level of CK-MB at 6 hours in the model group was significantly higher than that of the sham group,and peaked at 48 hours (U/L:749.8±42.2 vs.383.3±35.5 at 6 hours,3 340.1 ± 203.6 vs.704.6 ± 63.5 at 48 hours,both P ＜ 0.01).PaO2/FiO2 at 6 hours after the operation in model group was significantly lower than that of sham group,then it began to rise at the similar level in sham group at 48 hours [mmHg (1 mmHg =0.133 kPa):327.5±33.8 vs.424.8±31.0 at 6 hours,P ＜ 0.01;429.8 ±41.8 vs.464.7±43.3 at 48 hours,P ＞ 0.05].Ca2+ level in model group was continuously decreased after operation,and it was significantly lower than that of sham group at 48 hours (mmol/L:1.58 ± 0.14 vs.2.45 ± 0.21,P ＜ 0.01).The pancreatic edema was obvious after operation in sham group,with the observation time prolongation,the changes were gradually improved;pancreatic focal necrosis was found at 6 hours after operation in model group,and it was secondary aggravated,and pancreatic lobule structure disappearance and inflammatory cells extensive infiltration was found at 48 hours.Pathological score of the model group was significantly higher than that of sham group at each time point,and peaked at 48 hours (13.3 ±0.3 vs.3.0±0.1,P ＜ 0.01).Conclusion It is a highly efficient and low-cost way to induce biliogenic SAP in mice by retrograde injection of 3.5％ sodium deoxycholate into common bile duct via the self-made injection device,and the model conformed to the clinical characteristics of biliogenic SAP.

Overviews and analysis of the U.S. FDA′s new approvals in the 2015 second half year / 国际药学研究杂志

In the second half year of 2015,the U.S. Food and Drug Administration(FDA)approved 20 new molecular enti?ties single or compounds and 15 biologics license applications,a total of 35 which record number of approved innovative drugs. Ac?cording to the prescription information for professionals,this article briefly describes the description,mechanism of action and clinical studies,the box warning,indications and usage,dosage and administration,dosage form and strength,contraindications,warning and precautions,adverse reactions,drug interaction and use in special population of these new drugs. In addition,the first and criti?cal events in the history of new drug development and reaserch are emphasized.

Overviews and analysis of the U.S. FDA′s new approvals in first half year of 2015 / 国际药学研究杂志

In the first half year of 2015, the U.S. Food and Drug Administration(FDA) approved 11 new molecular entities and 5 new biologic license applications. According to the prescription information for professionals, this article introduces the description, mechanism of action and clinical studies; briefly describes the box warning, indications and usage, dosage and administration, dosage form and strength, contraindications, warning and precautions, adverse reactions, drug interaction and use in special population of these new drugs. In addition, the first and critical events in the history of new drug reaserch and development are emphasized.

Overviews and analysis of the U.S. FDA′s new approvals in 2014 first half year / 国际药学研究杂志

In the first half of 2014, the U.S. Food and Drug Administration (FDA) approved 46 new drugs, including 10 new molecular entities and 10 new biologic license applications. According to the prescription information for professionals, this article introduces the description, mechanism of action and clinical studies, briefly describs the box warning, indications and usage, dosage and administration, dosage form and strength, contraindications, warning and precautions, adverse reactions, drug interaction and use in special population of these new drugs. In addition, the “first events” in the history of new drug research, development and approval are also discussed.

Whole esophagus deep burns with a metal foreign body in the stomach: a case report / 南方医科大学学报

Whole esophagus deep burn is an extremely rare upper gastrointestinal tract disease. We report a case of severe burns of involving extensive body skin, eyes, throat, and esophagus. Endoscopic examination revealed acute necrotizing esophagitis and detected a metal foreign body in the stomach. The patient underwent burn wound debridement with analgesia, anti-shock rehydration, anti-infection, and symptomatic treatments, which failed to improve the conditions. The patient died of respiratory and circulatory failure secondary to serious sepsis.

Pre-clinical pharmacokinetics of recombinant heat shock protein 65-mucin 1 fusion protein vaccine / 中国药理学与毒理学杂志

OBJECTIVE To study the pharmacokinetics of heat shock protein 65-mucin 1 (HSP65-MUC1) recombinant fusion protein vaccine in Macaca mulatta monkeys and tumor-bearing mice. METHODS HSP65-MUC1 was labeled by radioactive isotope 125I. M. mulatta monkeys were randomly divided into sc and iv administration groups. Simultaneously, sc administration group was designed as a multiple dose group in which M. mulatta monkeys were sc given [ 125I] HSP65-MUC1 40 μg·g-1, once every 2 weeks for a total of 3 times. Size exclusion chromatography ( SEC) was used to determine concentrations of HSP65-MUC1 in serum samples. The tumor-bearing mice were randomly divided into 0.5, 1.5, 4, 8 and 24 h groups. Mice were sc given [125I] HSP65-MUC1 550 μg·kg-1, tissues were collected and tissue distribution of [125I] HSP65-MUC1 in tumor-bearing mice was studied using trichloroacetic acid (TCA) precipitation method. RESULTS The absolute bioavailability of [125I]HSP65-MUC1 was 38.33% after M. mulatta monkeys were sc given [125I]HSP65-MUC1. In multiple dose group, concentrations of [125I]HSP65-MUC1 after the third dose administration was compared to that of the first dose administration. The accumulation factor (AUC3/AUC1) was 1.17 ±0.25. Distribution of [ 125I]HSP65-MUC1 was significantly different compared with general polypeptide and protein drugs after sc in tumor-bearing mice. The concentration in lymph nodes was the highest. The concentration in other immune tissues, such as thymus and spleen, were not relatively high, but their declined tendency was slow after reaching the peak concentration (cmax ). However, the concentrations in the serum and some other tissues with a large blood volume, such as the heart, liver, and lung, were relatively low and declined quickly after reaching cmax. Its level in the tumor was not very high. [125 I] HSP65-MUC1 was excreted mainly by the kidneys. CONCLUSION The bioavailability of [125I]HSP65-MUC1 is 38.33% after sc administration in M. mulatta. After multiple-dose administration, the vaccine does not accumulate in the body, whose concentration is the highest in lymph nodes after [1251] HSP65-MUC1 was sc given in tumor-bearing mice, but is not very high in tumor. Besides, the vaccine declined tendency is slow after reaching cmax in immune tissues such as thymus and spleen compared with other tissues with a large blood volume.

Pharmacokinetics of [~(125)I]Huwentoxin-1 after epidural and intravenous administration to rhesus monkeys / 中国药理学通报

96% and with the same bio-activity as unlabeled Huwen toxin-1; Radioactivity detected in epidural space was 38% of injected radioacti vity at 10 min after epidural injection, which demonstrated successful administr ation into epidural space; The maximum serum concentration after epidural or iv administration of [ 125 I]labeled Huwentoxin-1 were determined to be (0 70?0 04) MBq?L -1 and (4 98?0 58) MBq?L -1 , respectively, a t the maximum serum concentration times of 30 min and 2 min. Terminal T 1/2 after epidural or iv administration were (10 36?0 27) h or (11 03?1 16) h, respectively. Cls was (1 29?0 07) L?h -1 ?kg -1 or (1 25? 0 23) L?h -1 ?kg -1 , respectively. Bioavailability after epidural a dministration was(95?5)%. CONCLUSION Concentration-time cur ves of [ 125 I] labeled Huwentoxin-1 after two routes were different. The degradation profiles after epidural and iv injection supported the using of HWTX-1 as analgesic by epidural administration.