The Experts below are selected from a list of 88407 Experts worldwide ranked by ideXlab platform
Amrit Ray - One of the best experts on this subject based on the ideXlab platform.
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changes in weight with depot medroxyprogesterone acetate Subcutaneous Injection 104 mg 0 65 ml
Contraception, 2007Co-Authors: Carolyn Westhoff, John K Jain, Ian Milsom, Amrit RayAbstract:Abstract Introduction The study was conducted to assess the impact of depot medroxyprogesterone acetate Subcutaneous Injection 104 mg/0.65 mL (DMPA-SC 104) on body weight. Methods Changes in weight from pretreatment were analyzed using data from two 1-year, noncomparative trials of DMPA-SC 104 (North/South American, N =722; European/Asian, N =1065) and a 3-year, randomized study (SC/IM) comparing DMPA-SC 104 ( N =266) with the DMPA intramuscular Injection 150 mg/mL (DMPA-IM 150). For each study, additional analyses were conducted for changes in body weight by age ( 35 years) and body mass index (BMI) (���25, >25 to ���30 and >30 kg/m 2 ) subgroups. Results In both 1-year trials, the mean (��SD) weight gain at month 12 was Conclusion DMPA-SC 104 was associated with modest weight gain in most women.
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changes in bleeding patterns with depot medroxyprogesterone acetate Subcutaneous Injection 104 mg
Contraception, 2006Co-Authors: Raquel D Arias, John K Jain, Cosima Brucker, Doug Ross, Amrit RayAbstract:Abstract Objective This study aims to assess changes in bleeding patterns with the use of depot medroxyprogesterone acetate (DMPA) 104 mg/0.65 ml Subcutaneous Injection (DMPA-SC 104). Study Design An analysis was conducted using data from two 1-year, noncomparative clinical trials (N=1787) and a 2-year randomized study comparing DMPA-SC 104 (N=266) with DMPA intramuscular Injection (DMPA-IM). Bleeding was analyzed per 30-day interval by category and number of days. Analyses also were performed for age and body mass index (BMI) subgroups and for the percentages of women shifting from bleeding/spotting to amenorrhea after each Injection. Results Each study showed decreased incidence of irregular bleeding and increased amenorrhea with continued use of DMPA-SC 104. Rates of amenorrhea at Month 12 (52–64% across studies) and Month 24 (71% in the 2-year trial) were comparable with those originally reported for DMPA-IM. Changes in bleeding patterns showed no consistent differences according to age or BMI. The percentages of subjects shifting from bleeding and/or spotting to amenorrhea increased with each subsequent Injection. Conclusion Clinical data show that the incidence of amenorrhea increases over time with the use of DMPA-SC 104.
John K Jain - One of the best experts on this subject based on the ideXlab platform.
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changes in weight with depot medroxyprogesterone acetate Subcutaneous Injection 104 mg 0 65 ml
Contraception, 2007Co-Authors: Carolyn Westhoff, John K Jain, Ian Milsom, Amrit RayAbstract:Abstract Introduction The study was conducted to assess the impact of depot medroxyprogesterone acetate Subcutaneous Injection 104 mg/0.65 mL (DMPA-SC 104) on body weight. Methods Changes in weight from pretreatment were analyzed using data from two 1-year, noncomparative trials of DMPA-SC 104 (North/South American, N =722; European/Asian, N =1065) and a 3-year, randomized study (SC/IM) comparing DMPA-SC 104 ( N =266) with the DMPA intramuscular Injection 150 mg/mL (DMPA-IM 150). For each study, additional analyses were conducted for changes in body weight by age ( 35 years) and body mass index (BMI) (���25, >25 to ���30 and >30 kg/m 2 ) subgroups. Results In both 1-year trials, the mean (��SD) weight gain at month 12 was Conclusion DMPA-SC 104 was associated with modest weight gain in most women.
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changes in bleeding patterns with depot medroxyprogesterone acetate Subcutaneous Injection 104 mg
Contraception, 2006Co-Authors: Raquel D Arias, John K Jain, Cosima Brucker, Doug Ross, Amrit RayAbstract:Abstract Objective This study aims to assess changes in bleeding patterns with the use of depot medroxyprogesterone acetate (DMPA) 104 mg/0.65 ml Subcutaneous Injection (DMPA-SC 104). Study Design An analysis was conducted using data from two 1-year, noncomparative clinical trials (N=1787) and a 2-year randomized study comparing DMPA-SC 104 (N=266) with DMPA intramuscular Injection (DMPA-IM). Bleeding was analyzed per 30-day interval by category and number of days. Analyses also were performed for age and body mass index (BMI) subgroups and for the percentages of women shifting from bleeding/spotting to amenorrhea after each Injection. Results Each study showed decreased incidence of irregular bleeding and increased amenorrhea with continued use of DMPA-SC 104. Rates of amenorrhea at Month 12 (52–64% across studies) and Month 24 (71% in the 2-year trial) were comparable with those originally reported for DMPA-IM. Changes in bleeding patterns showed no consistent differences according to age or BMI. The percentages of subjects shifting from bleeding and/or spotting to amenorrhea increased with each subsequent Injection. Conclusion Clinical data show that the incidence of amenorrhea increases over time with the use of DMPA-SC 104.
Rene Van Der Merwe - One of the best experts on this subject based on the ideXlab platform.
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tralokinumab pharmacokinetics and tolerability when administered by different Subcutaneous Injection methods and rates
Principles and Practice of Constraint Programming, 2017Co-Authors: Meena Jain, Diane V Doughty, Corbin Clawson, Xiaobai Li, Nicholas White, Balaji Agoram, Rene Van Der MerweAbstract:Objective Tralokinumab, administered as two 1-mL Subcutaneous Injections every 2 weeks, at the target dose 300 mg, has been shown to improve lung function in patients with asthma. This study evaluated the pharmacokinetic (PK) and tolerability profile of tralokinumab 300 mg when administered by different rates of Subcutaneous Injection, as part of a pilot investigation of new Injection regimens. Methods This phase I study randomized 60 healthy adults to receive 300 mg tralokinumab, as two 1-mL Subcutaneous Injections, each delivered over 10 seconds, or one 2-mL Injection delivered over 10 seconds (12 mL/min), 1 minute (2 mL/min), or 12 minutes (0.167 mL/min). Results No differences in the PK profile of tralokinumab were observed between cohorts. Immediately following Injection, Injection-site pain intensity (mean (SD)) was lowest following 0.167 mL/min Injection (5.1 mm (8.0) via visual analog scale (VAS)) and greatest following 12 mL/min Injection (41 mm (27.7) via VAS); with mean Injection-site pruritus intensity low for all participants. Two types of local Injection-site reactions were observed: erythema (58.3%) and hematoma/bleeding (18.3%). All treatment-emergent adverse events were mild. Conclusions Tralokinumab 300 mg is well tolerated, with comparable PK, when administered by a single 2-mL Injection at different rates of Subcutaneous Injection vs. two 1-mL Injections. .
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Tralokinumab pharmacokinetics and tolerability when administered by different Subcutaneous Injection methods and rates .
International journal of clinical pharmacology and therapeutics, 2017Co-Authors: Meena Jain, Diane V Doughty, Corbin Clawson, Xiaobai Li, Nicholas White, Balaji Agoram, Rene Van Der MerweAbstract:OBJECTIVE: Tralokinumab, administered as two 1-mL Subcutaneous Injections every 2 weeks, at the target dose 300 mg, has been shown to improve lung function in patients with asthma. This study evaluated the pharmacokinetic (PK) and tolerability profile of tralokinumab 300 mg when administered by different rates of Subcutaneous Injection, as part of a pilot investigation of new Injection regimens. METHODS: This phase I study randomized 60 healthy adults to receive 300 mg tralokinumab, as two 1-mL Subcutaneous Injections, each delivered over 10 seconds, or one 2-mL Injection delivered over 10 seconds (12 mL/min), 1 minute (2 mL/min), or 12 minutes (0.167 mL/min). RESULTS: No differences in the PK profile of tralokinumab were observed between cohorts. Immediately following Injection, Injection-site pain intensity (mean (SD)) was lowest following 0.167 mL/min Injection (5.1 mm (8.0) via visual analog scale (VAS)) and greatest following 12 mL/min Injection (41 mm (27.7) via VAS); with mean Injection-site pruritus intensity low for all participants. Two types of local Injection-site reactions were observed: erythema (58.3%) and hematoma/bleeding (18.3%). All treatment-emergent adverse events were mild. CONCLUSIONS: Tralokinumab 300 mg is well tolerated, with comparable PK, when administered by a single 2-mL Injection at different rates of Subcutaneous Injection vs. two 1-mL Injections. .
Michael Douek - One of the best experts on this subject based on the ideXlab platform.
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deposition of superparamagnetic iron oxide nanoparticles in axillary sentinel lymph nodes following Subcutaneous Injection
Histopathology, 2013Co-Authors: Laura Johnson, Sarah E Pinder, Michael DouekAbstract:Aims Superparamagnetic iron oxide nanoparticle (SPIO)-enhanced axillary lymph node magnetic resonance imaging (MRI) has the potential to supersede sentinel lymph node (SLN) biopsy in the management of early breast cancer with in vivo pre-operative metastasis detection. We evaluated the distribution and extent of SPIOs within the SLN and its impact on routine histological assessment. Methods and results A total of 131 SLNs from 51 consecutive patients with breast cancer were examined histologically following Subcutaneous Injection of 2–4 ml SPIOs. SLNs were identified intra-operatively using the combined technique. Ex vivo histological analysis was performed and the distribution of SPIOs assessed using standard haematoxylin and eosin staining. SPIO distribution was predominantly within lymph node sinuses (81%); fewer nodes contained iron in the subcapsular space (24%) and parenchyma (14%). In 58%, SPIOs were sequestered in macrophages. SPIOs were not seen within the areas of nodes containing metastases, but was seen surrounding the metastases. Conclusions Following Subcutaneous Injection of SPIOs, iron deposition is found predominantly in sinuses and the subcapsular space and is not found in areas containing metastases. This reinforces the notion that high resolution SPIO-enhanced MRI has the potential for in vivo metastasis in the SLN in breast cancer. Routine histological examination was unaffected.
Carolyn Westhoff - One of the best experts on this subject based on the ideXlab platform.
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changes in weight with depot medroxyprogesterone acetate Subcutaneous Injection 104 mg 0 65 ml
Contraception, 2007Co-Authors: Carolyn Westhoff, John K Jain, Ian Milsom, Amrit RayAbstract:Abstract Introduction The study was conducted to assess the impact of depot medroxyprogesterone acetate Subcutaneous Injection 104 mg/0.65 mL (DMPA-SC 104) on body weight. Methods Changes in weight from pretreatment were analyzed using data from two 1-year, noncomparative trials of DMPA-SC 104 (North/South American, N =722; European/Asian, N =1065) and a 3-year, randomized study (SC/IM) comparing DMPA-SC 104 ( N =266) with the DMPA intramuscular Injection 150 mg/mL (DMPA-IM 150). For each study, additional analyses were conducted for changes in body weight by age ( 35 years) and body mass index (BMI) (���25, >25 to ���30 and >30 kg/m 2 ) subgroups. Results In both 1-year trials, the mean (��SD) weight gain at month 12 was Conclusion DMPA-SC 104 was associated with modest weight gain in most women.
