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Boddy Alexander W. Snikeris Fred C. Kringle Robert O. Wei Greg C. G. Oppermann James A. Midha K. K. 《Pharmaceutical research》1995,12(12):1865-1868
Purpose. Highly variable drugs pose a problem in bioequivalence assessment because they often fail to meet current regulatory acceptance criteria for average bioequivalence (80–125%). This paper examines alternative approaches to establishing bioequivalence.
Methods. Suggested solutions have included alternate study designs, e.g., replicate and multiple dose studies, reducing the level of the confidence interval, and widening the acceptance limits. We focus on the latter approach.
Results. A rationale is presented for defining wider acceptance limits for highly variable drugs. Two previously described methods are evaluated, and a new method having more desirable properties is proposed.
Conclusions. We challenge the one size fits all current definition of bioequivalence acceptance limits for highly variable drugs, proposing alternative limits or goal posts which vary in accordance with the intrasubject variability of the reference product. 相似文献
3.
The conduct of in vitro and in vivo drug-drug interaction studies: a Pharmaceutical Research and Manufacturers of America (PhRMA) perspective. 总被引:12,自引:0,他引:12
Thorir D Bjornsson John T Callaghan Heidi J Einolf Volker Fischer Lawrence Gan Scott Grimm John Kao S Peter King Gerald Miwa Lan Ni Gondi Kumar James McLeod R Scott Obach Stanley Roberts Amy Roe Anita Shah Fred Snikeris John T Sullivan Donald Tweedie Jose M Vega John Walsh Steven A Wrighton 《Drug metabolism and disposition》2003,31(7):815-832
Current regulatory guidances do not address specific study designs for in vitro and in vivo drug-drug interaction studies. There is a common desire by regulatory authorities and by industry sponsors to harmonize approaches, to allow for a better assessment of the significance of findings across different studies and drugs. There is also a growing consensus for the standardization of cytochrome P450 (P450) probe substrates, inhibitors and inducers and for the development of classification systems to improve the communication of risk to health care providers and to patients. While existing guidances cover mainly P450-mediated drug interactions, the importance of other mechanisms, such as transporters, has been recognized more recently, and should also be addressed. This article was prepared by the Pharmaceutical Research and Manufacturers of America (PhRMA) Drug Metabolism and Clinical Pharmacology Technical Working Groups and represents the current industry position. The intent is to define a minimal best practice for in vitro and in vivo pharmacokinetic drug-drug interaction studies targeted to development (not discovery support) and to define a data package that can be expected by regulatory agencies in compound registration dossiers. 相似文献
4.
F Mandelli R Latagliata G Avvisati P Fazi F Rodeghiero F Leoni M Gobbi F Nobile E Gallo R Fanin S Amadori M Vignetti G Fioritoni F Ferrara A Peta R Giustolisi G Broccia M C Petti F Lo-Coco 《Leukemia》2003,17(6):1085-1090
In all, 134 elderly patients (median age 66 years, range 60-75 years) with newly diagnosed acute promyelocytic leukemia (APL) were enrolled in two successive protocols of the Italian multicenter group GIMEMA. All patients received an identical induction with all-trans retinoic acid and idarubicin; 116 (86%) entered complete remission (CR), two (2%) were resistant and 16 (12%) died during induction. After CR, 106 patients received further therapy whereas 10 did not, because of refusal (n=5) or toxicity (n=5). Consolidation consisted of three chemotherapy courses in the AIDA protocol (AIDA, 67 patients) or, since 1997, of an amended protocol including only the first cycle (amended AIDA, aAIDA, 39 patients). In the AIDA group, 43 patients (64%) completed consolidation, while seven (11%) and 17 (25%) patients were withdrawn after first and second courses, respectively; nine patients (13%) died in CR and 12 (18%) relapsed. In the aAIDA group, all patients received the assigned treatment; two patients (5%) died in CR and six (15%) relapsed. In the AIDA and aAIDA series, the 3-year overall and discase-free survival rates were 81 and 83% (P=NS), 73 and 72% (P=NS), respectively. We highlight here the frequency and severity of complications linked to intensive chemotherapy in this clinical setting and suggest that, in APL of the elderly, less intensive postremission therapy allows significant reduction of severe treatment-related toxicity and may be equally effective. 相似文献
5.
Thamara M. Wijesuriya Peta Perry Todd Pryce John Boehm Ian Kay James Flexman Geoffrey W. Coombs Paul R. Ingram 《Journal of clinical microbiology》2014,52(8):2829-2833
Active surveillance is part of a multifaceted approach used to prevent the spread of vancomycin-resistant enterococci (VRE). The impact of fecal density, the vancomycin MIC of the isolate, and the vancomycin concentration in liquid medium on test performance are uncertain. Using fecal specimens spiked with a collection of 18 VRE (predominantly vanB) with a wide vancomycin MIC range, we compared the performances of commercial chromogenic agars (CHROMagar VRE, chromID VRE, Brilliance VRE, and VRE Select) and 1 liquid medium (Enterococcosel enrichment broth) for VRE detection. The specificity of solid media was excellent; however, the sensitivity at 48 h varied from 78 to 94%. Screening using liquid medium was less sensitive than screening with solid media, particularly as the vancomycin content increased. Sensitivity declined (i) as the fecal VRE density decreased, (ii) when the media were assessed at 24 h (versus 48 h), and (iii) for isolates with a low vancomycin MIC (sensitivity, 25 to 75% versus 100% for isolates with vancomycin MIC of <16 mg/liter versus >32 mg/liter on solid medium using 106 CFU/ml of feces). Depending on local epidemiology and in particular VRE vancomycin MICs, the sensitivity of culture-based methods for VRE screening of stool or rectal specimens may be suboptimal, potentially facilitating secondary transmission. 相似文献
6.
Erin M. Nesbitt-Hawes Peta E. Maley Ha Ryun Won Kenneth S.K. Law Christine S. Zhang Stephen D. Lyons William Ledger Jason A. Abbott 《Journal of minimally invasive gynecology》2013,20(4):424-434
Laparoscopic subtotal/supracervical hysterectomy (LSH) is a surgical option when hysterectomy is indicated. Proponents of LSH suggest possible advantages including reduced recovery time, decreased risk of pelvic organ prolapse, and decreased risk of organ damage, in particular to the urinary tract. Opponents of LSH have suggested that the future risk of cervical malignancy, the possibility of ongoing cyclical bleeding, limited morbidity due to total laparoscopic hysterectomy, and similar clinical outcomes render this approach unnecessary. One study compared LSH with laparoscopically assisted vaginal hysterectomy in a randomized controlled trial that reported psychologic and sexual outcomes; however, no clinical data were published. The present review outlines techniques for subtotal hysterectomy and critically appraises the available evidence for outcomes including operative data, short- and long-term complications, and functional outcomes. 相似文献
7.
S. Wayne Miles Janie Sheridan Bruce Russell Rob Kydd Amanda Wheeler Carina Walters Greg Gamble Peta Hardley Maree Jensen Kimmo Kuoppasalmi Pekka Tuomola Jaana Föhr Outi Kuikanmäki Helena Vorma Raimo Salokangas Antti Mikkonen Mika Kallio Jussi Kauhanen Vesa Kiviniemi Jari Tiihonen 《Addiction (Abingdon, England)》2013,108(7):1279-1286
8.
9.
Jake L. Nowicki Daniel Mullany Amy Spooner Tracy A. Nowicki Peta M. Mckay Amanda Corley Paul Fulbrook John F. Fraser 《Australian critical care》2018,31(5):257-263
Background
Pressure injuries contribute significantly to patient morbidity and healthcare costs. Critically ill patients are a high risk group for pressure injury development and may suffer from skin failure secondary to hypoperfusion. The aim of this study was to report hospital acquired pressure injury incidence in intensive care and non-intensive care patients; and assess the clinical characteristics and outcomes of ICU patients reported as having a hospital acquired pressure injury to better understand patient factors associated with their development in comparison to ward patients.Methods
The setting for this study was a 630 bed, government funded, tertiary referral teaching hospital. A secondary data analysis was undertaken on all patients with a recorded PI on the hospital’s critical incident reporting systems and admitted patient data collection between July 2006 to March 2015.Results
There were a total of 5280 reports in 3860 patients; 726 reports were intensive care patients and 4554 were non-intensive care patients, with severe hospital acquired PI reported in 22 intensive care patients and 54 non-intensive care patients. Pressure injury incidence increased in intensive care patients and decreased in non-intensive care patients over the study period. There were statistically significant differences in the anatomical location of severe hospital acquired pressure injuries between these groups (p = 0.008).Conclusion
Intensive care patients have greater than 10-fold higher hospital acquired pressure injury incidence rates compared to other hospitalised patients. The predisposition of critically ill patients leaves them susceptible to pressure injury development despite implementation of pressure injury prevention strategies. Skin failure appears to be a significant phenomenon in critically ill patients and is associated with the use of vasoactive agents and support systems such as extra corporeal membrane oxygenation and mechanical ventilation. 相似文献10.