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Investigation of fertility and early embryonic toxicity of caffeine in rats

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中国药理学与毒理学杂志 2013年第3期 603-604页

作者： WANG Hong-ping PAN Lei Sue MCPHERSON Steve MASON wuxi apptec(Suzhou) co. Ltd.

OBJECTIVE To investigate the fertility and early embryonic developmental toxicity of *** 160 rats were assigned to 4 groups of 20 /sex /group,with vehicle or test article administered at dosages of 0,20,40 or 80 mg·kg-1.d-1 once daily by oral *** were dosed for 4 weeks and females were dosed for 2 weeks prior to mating and dosing continued during the cohabitation *** were treated thereafter to termination after a dosing duration of 54 to 63 *** females mated successfully and were dosed thereafter up to gesation day(GD) *** were c-sectioned on *** compared to the concurrent vehicle control group,the absolute body weight gain decreased significantly during the dosing period for males dosed at 40-80 mg·kg-1.d-1 and for females dosed at 80 mg·*** decreases were associated with decreased food *** of the test article was also noted to affect spermatogenesis in *** increases in sperm morphological abnormalities and decreases in sperm motility were observed following dosing at 40-80 mg·*** addition,a significant decrease in sperm count was also observed for animals dosed at 80 mg·*** were no test article-related changes in cohabitation duration,estrus cycle(start from 7 d prior to mating,and continued during pairing period),fertility data,uterine observations(*** corpora lutea,implantations,live fetuses,embryonic resorptions,pre-implantation loss,post-implantation loss),reproductive organ weights,and macroscopic *** findings were considered to indicate that caffe-ine dosed at 20-80 mg·kg-1.d-1 did not affect female fertility and early embryonic development to *** The No-Observed-Adverse-Effect-Level(NOAEL) of caffeine on spermatogenesis was considered to be 20 mg·kg-1.d-1,and the NOAEL of caffeine on female fertility and early development to implantation was considered to be 80 mg·kg-1.d-1.

关键词： caffeine embryonic toxicity

Use of the DSI/Ponemah jacketed external telemetry system for ECG assessments in dog telemetry

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中国药理学与毒理学杂志 2013年第3期 601-602页

作者： WU Rui QU Lin-hai Sue McPHERSON Steve MASON Safety Pharmacology WuXi AppTec(Suzhou) Co.Ltd.

OBJECTIVE To demonstrate that the DSI /Ponemah Jet System(v5.00) can generate high quality ECG data with current methods,enabling cardiovascular function to be assessed in free moving dogs in their home *** Four male beagle dogs were used on this *** electrodes were placed on each animal and were connected to each JET *** JET device was then placed into a pocket of an externally worn animal jacket for each *** JET device transmits to a Bluetooth? *** Bluetooth? receiver can receive signals from up to 6 JET devices depending upon the device *** JET device can transmit data up to 10 meters with negligible interference and no cross-talk exists between *** animals underwent acclimatization to jackets prior to commencement of *** dog was placed into a pen and ECG measurements taken simultaneously using the DSI /Ponemah Jet *** were recorded for 1 hour pre-dose and continually for the following 23 hours under control conditions,then dosed with ascending doses of Moxifloxacin at intervals of 48 hours between each *** AND coNCLUSION Prolonged QT and QTcV(Van de Water's correction) interval was observed for animals dosed at 100 mg·kg-1 from 4-23 h *** QTcV effects(19% increase with 100 mg·kg-1 Moxifloxacin vs control).The DSI telemetry system performed well when testing the dog to the known pharmacological profile of *** sensitively and efficiently acquired ECG data from the beagle dogs and demonstrated the sensitivity of the system to detect test article induced QT *** allows a colony of dogs to be dedicated for toxicology and safety pharmacology *** DSI /ponemah JET system enables flexibility in study design and can be utilized on a range of study types to facilitate high quality ECGs and reduce the requirement for repeat dosing safety pharmacology *** data generated from this investigation demonstrate the DSI /ponemah JET system(v5.

关键词： ECG dog

comparison of body weight and food consumption in young adult SD rats

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Comparison of body weight and food consumption in young adul...

2013年（第三届）中国药物毒理学年会暨药物非临床安全性评价研究论坛

作者： GUO H Sue McPHERSON Steve MASON wuxi apptec co.ltd.

An meta-analysis was performed for control animals from over 25 toxicology studies to assess potential differences in body weight gain and food consumption between Sprague-Dawley rats sourced from commercial suppliers in the USA(Charles River-"CR"),***(Vital River-"VR") and Taiwan(BioLasco-"BL").The mean body weight and food consumption was calculated weekly for animals in the age range 6 to 35 *** to approximately 15 weeks of age,CR males were generally lighter than BL males,after this time the growth rate of the CR males appeared to exceed that of those from BL.A similar pattern was seen for female rats with the CR animals exhibiting lower body weight than BL rats before approximately 11 weeks of *** age 11 weeks the CR rats were heavier than BL *** VR animals, initial growth was similar to CR rats,and followed closer to the BL growth rate from approximately week *** general, the CR male and female SD rats grew faster than those from either BL or *** the male rats there were no clear differences in food consumption between CR and BL animals,in comparison food consumption for the VR rats was a little lower. For the females,CR rats tended to show a higher food intake than both BL and VR,with the food for consumption from animals from the latter two sources being generally *** observed differences between the three sources of animals demonstrate the need to be consistent in the source of animals for different studies in toxicology development programs with a single compound,and also the need for maintaining separate back ground data bases.

关键词： body mass food consumption

comparison of body weight and food consumption in young adult SD rats

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Comparison of body weight and food consumption in young adul...

作者： GUO H Sue McPHERSON Steve MASON wuxi apptec co.ltd.

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comparison of body weight and food consumption in young adult SD rats

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中国药理学与毒理学杂志 2013年第3期 553-553页

作者： GUO H Sue McPHERSON Steve MASON wuxi apptec co.ltd.

An meta-analysis was performed for control animals from over 25 toxicology studies to assess potential differences in body weight gain and food consumption between Sprague-Dawley rats sourced from commercial suppliers in the USA(Charles River-″CR″),***(Vital River-″VR″) and Taiwan(BioLasco-″BL″).The mean body weight and food consumption was calculated weekly for animals in the age range 6 to 35 *** to approximately 15 weeks of age,CR males were generally lighter than BL males,after this time the growth rate of the CR males appeared to exceed that of those from BL.A similar pattern was seen for female rats with the CR animals exhibiting lower body weight than BL rats before approximately 11 weeks of *** age 11 weeks the CR rats were heavier than BL *** VR animals,initial growth was similar to CR rats,and followed closer to the BL growth rate from approximately week *** general,the CR male and female SD rats grew faster than those from either BL or *** the male rats there were no clear differences in food consumption between CR and BL animals,in comparison food consumption for the VR rats was a little *** the females,CR rats tended to show a higher food intake than both BL and VR,with the food for consumption from animals from the latter two sources being generally *** observed differences between the three sources of animals demonstrate the need to be consistent in the source of animals for different studies in toxicology development programs with a single compound,and also the need for maintaining separate back ground data bases.

关键词： body mass food consumption

A sensitive, simple and rapid HPLC–MS/MS method for simultaneous quantification of buprenorpine and its N-dealkylated metabolite norbuprenorphine in human plasma

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Journal of Pharmaceutical Analysis 2013年第4期3卷 221-228页

作者： Yi-Ya Wang Xiao-Hang Shen Hao Li Feng-Ju Chen Yan Fu Li Ding Department of Pharmaceutical Analysis China Pharmaceutical University Bioanalytical Service WuXi AppTec Co. Ltd.

A sensitive, simple and rapid high performance liquid chromatography-tandem mass spectrometry （HPLC-MS/MS） method was developed and fully validated for the simultaneous quantification of buprenorphine （BUP） and its N-dealkylated metabolite norbuprenorphine （NBUP） in 200 μL human plasma. Human plasma samples were prepared using liquid-liquid extraction, and then separated on a Shiseido MG C18 （5 μm, 2.0 mm × 50 mm） via 4.1 min gradient elution. Following electrospray ionization, the analytes were quantified on a triple-quadrupole mass spectrometer in multiple-reaction-monitoring （MRM） positive ion mode. Linearity was achieved from 25.0 to 10000 pg/mL for buprenorphine, from 20.0 to 8000 pg/mL for norbupre- norphine with r2〉0.99. The method was demonstrated with acceptable accuracy, precision and specificity for the detection of buprenorphine and norbuprenorphine. Recovery was 81.8-88.8 % for buprenorphine and 77.0-84.6% for norbuprenorphine, and the matrix effect was 95.6-97.4% for buprenorphine and 94.0-96.9% for norbuprenorphine; all were not concentration dependent. With validated matrix and autosampler stability data, this method was successfully applied in a bioequivalence study to support abbreviated new drug application.

关键词： Buprenorphine Norbuprenorphine Human plasma HPLC-MS/MS

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combined gemcitabine and CHK1 inhibitor treatment induces apoptosis resistance in cancer stem cell-like cells enriched with tumor spheroids from a non-small cell lung cancer cell line

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Frontiers of Medicine 2013年第4期7卷 462-476页

作者： Douglas D.Fang Joan Cao Jitesh P.Jani Konstantinos Tsaparikos Alessandra Blasina Jill Kornmann Maruja E.Lira Jianying Wang Zuzana Jirout Justin Bingham Zhou Zhu Yin Gu Gerrit Los Zdenek Hostomsky Todd VanArsdale Oncology Research Unit PfizerInc.10777 Science Center DriveSan DiegoCA 92121USA wuxi apptec(Shanghai)co. Ltd.288 Fute Zhong RdWaigaoqiao Free Trade ZoneShanghai 200131China

Evaluating the effects of novel drugs on appropriate tumor models has become crucial for developing more effective therapies that target highly tumorigenic and drug-resistant cancer stem cell(CSC)*** this study,we demonstrate that a subset of cancer cells with CSC properties may be enriched into tumor spheroids under stem cell conditions from a non-small cell lung cancer cell *** these CSC-like cells with gemcitabine alone and a combination of gemcitabine and the novel CHK1 inhibitor PF-00477736 revealed that PF-00477736 enhances the anti-proliferative effect of gemcitabine against both the parental and the CSC-like cell ***,the CSC-like cells exhibited resistance to gemcitabine-induced ***,the spheroid-forming CSC-like cells may serve as a model system for understanding the mechanism underlying the drug resistance of CSCs and for guiding the development of better therapies that can inhibit tumor growth and eradicate CSCs.

关键词： drug resistance cancer stem cell checkpoint kinase 1(CHK1) PF-00477736 lung cancer tumorigenicity

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Investigation of fertility and early embryonic toxicity of caffeine in rats

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Investigation of fertility and early embryonic toxicity of c...

2013年（第三届）中国药物毒理学年会暨药物非临床安全性评价研究论坛

作者： WANG Hong-ping PAN Lei Sue MCPHERSON Steve MASON wuxi apptec(Suzhou) co. Ltd.

OBJECTIVE To investigate the fertility and early embryonic developmental toxicity of *** 160 rats were assigned to 4 groups of 20/sex/group,with vehicle or test article administered at dosages of 0,20,40 or 80 mg·kg·d once daily by oral *** were dosed for 4 weeks and females were dosed for 2 weeks prior to mating and dosing continued during the cohabitation *** were treated thereafter to termination after a dosing duration of 54 to 63 *** females mated successfully and were dosed thereafter up to gesation day(GD) *** were c-sectioned on *** compared to the concurrent vehicle control group,the absolute body weight gain decreased significantly during the dosing period for males dosed at 40 -80 mg ? kg?d and for females dosed at 80 mg·kg·*** decreases were associated with decreased food *** of the test article was also noted to affect spermatogenesis in *** increases in sperm morphological abnormalities and decreases in sperm motility were observed following dosing at 40 -80 mg·kg·*** addition,a significant decrease in sperm count was also observed for animals dosed at 80 mg·kg·*** were no test article-related changes in cohabitation duration,estrus cycle(start from 7 d prior to mating,and continued during pairing period),fertility data,uterine observations (*** corpora lutea,implantations,live fetuses,embryonic resorptions,pre-implantation loss,post-implantation loss),reproductive organ weights,and macroscopic *** findings were considered to indicate that caffe- ine dosed at 20 -80 mg·kg·d did not affect female fertility and early embryonic development to *** The No-Observed-Adverse-Effect-Level(NOAEL) of caffeine on spermatogenesis was considered to be 20 mg·kg·d,and the NOAEL of caffeine on female fertility and early development to implantation was considered to be 80 mg·kg·d.

关键词： caffeine embryonic toxicity

Use of respiratory "head out" plethysmographs for evaluation of pulmonary function in rats

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Use of respiratory "head out" plethysmographs for evaluation...

作者： WU Rui QU Lin-hai Sue MCPHERSON Steve MASON Safety Pharmacology WuXi AppTec(Suzhou)Co.Ltd

To evaluate the use of respiratory "head out" plethysmographys for use as a respiratory function assessment tool in rats as part of the respiratory system assessment required under the ICH S7A ***(20 mg·kg~(-1) iv) and Theophylline(10 mg·kg~(-1)iv) were selected for use as reference compounds in this *** Sprague- Dawley rats,approximately 7 -8 weeks of age and in the weight range 246 -303 g were selected as the test *** approximate one week acclimation period preceded the study,during which animals were pre-selected for the suitability by assessment of their ability to stay in the restraint chambers("head-out" plethysmographys) for a target of about 2.5 h-Any rat demonstrating excessive excitability or abnormal breathing patterns were removed from the *** the day of dosing, animals were placed in "head out" plethysmographs and allowed to acclimate to the chambers for at least 5 min prior to each data collection *** following the acclimation period,ventilatory parameters(tidal volume,respiratory rate,and derived respiratory minute volume(RMV) were measured for an approximate 15 min period predose,continuously for the following approximate 2.5 h,then for approximate 15 min at approximately 4 and 24 h *** obtained were consistent with the literature and based on the results of this study,this assay,using respiratory "head out" plethysmographys to assess respiratory function,is considered acceptable for use in Pulmonary assessments under the ICH guideline.

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