Purpose The aims of this study were to examine a national database to assess codeine poisonings before and after the new guidance for pharmacists while also evaluating rates of codeine prescriptions following the intr...
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Purpose The aims of this study were to examine a national database to assess codeine poisonings before and after the new guidance for pharmacists while also evaluating rates of codeine prescriptions following the introduction of restrictions on supply. Methods Anonymised enquiry data of reported poisoning cases were reviewed for a period from 2005 to 2016 inclusive. The rate of pharmacy claims for codeine containing products was also examined using the national pharmacy claims database. Segmented regression analysis was used to detect changes in poisonings and claims before and after the new guidance. Results There were 1851 codeine-related poisonings reported over the study period. An annual decline was evident with a significant 33% reduction from 2010 to 2011 (beta 2 coefficient for level change, 42.1;95% CI, -68.1 to -16.0;P = 0.006). Following 2011, the declining rate of codeine poisonings plateaued. Analysis of the national pharmacy claims data revealed no change in the reimbursement rate for co-codamol products restricted by the guidance in 2010 (Incidence rate ratio 1.04, 95% CI, 0.997-1.08;P = 0.07). There was no corresponding increase in the reimbursement of alternative opioid medications. Conclusions New guidance on codeine supply coincided with an initial reduction in reported codeine poisoning cases. This reduction was in keeping with the previous trend. However, this was without an increase in the prevailing rate of prescription claims for these products or potential substitutes. Policymakers may consider further restriction of codeine products to improve public health outcomes.
Tianwen-1,the first mission of China's planetary exploration program,accomplished its goals of orbiting,landing,and roving on the *** entry,descent,and landing(EDL)phase directly determines the success of the enti...
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Tianwen-1,the first mission of China's planetary exploration program,accomplished its goals of orbiting,landing,and roving on the *** entry,descent,and landing(EDL)phase directly determines the success of the entire mission,of which the guidance,navigation,and control(GNC)system is *** paper outlines the Tianwen-1 EDL GNC system design by introducing the GNC requirements followed by presenting the GNC system architecture and algorithms to meet such *** actual flight results for the whole EDL phase are also provided in this paper.
作者：
Itoh, SayakaKano, ShingoUniv Tokyo
Grad Sch Frontier Sci Dept Computat Biol & Med Sci Bioinnovat Policy Unit Biosci Bldg B-175-1-5 Kashiwanoha Kashiwa Chiba 8562 Japan
In the advanced medical field, there is a constant need for efficient guidance formulation by regulators. Technology forecasting as a surveillance for regulation needs may be an effective solution by notifying regulat...
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In the advanced medical field, there is a constant need for efficient guidance formulation by regulators. Technology forecasting as a surveillance for regulation needs may be an effective solution by notifying regulatory authorities of the possible future changes in regulations. However, the lack of tangible frameworks has made the relationship between technology forecasting and regulation difficult to comprehend, and has led to an under-analyzed state of how technology forecasts are implemented into the guidance formulation process. In this study, we introduce a framework built specifically for facilitating the comprehension of the relationship between technologies enlisted in technology forecasting and guidances formulated after the forecasting, and applied the framework to a case of technology forecasting conducted by regulatory authorities in Japan. Four patterns of the relationships between a technology forecasting conducted by regulators and the guidances developed after the forecast are identified. The results and discussions provide suggestions of technology forecast design and application in the guidance formulation process by regulators in the field of medical devices.
On April 7th,2023,the supervisory department of Xuhui district published the first guidance to“Cosmetics Samples”for the First Time(Trial).It unified the management requirement regarding cosmetics samples,guided man...
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On April 7th,2023,the supervisory department of Xuhui district published the first guidance to“Cosmetics Samples”for the First Time(Trial).It unified the management requirement regarding cosmetics samples,guided managers to develop responsibility awareness and prevent and advert risks ***,it identified the definition of“cosmetics samples”.
Since it can be challenging for users to effectively utilize interactive visualizations,guidance is usually provided to assist users in solving *** is mentioned as an effective mean to overcome stall situations occurr...
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Since it can be challenging for users to effectively utilize interactive visualizations,guidance is usually provided to assist users in solving *** is mentioned as an effective mean to overcome stall situations occurring during the ***,the effectiveness of a peculiar guidance solution usually varies for different analysis *** same guidance may have different effects on users with(1)different levels of *** choice of the appropriate(2)degree of guidance and the type of(3)task under consideration also affect the positive or negative outcome of providing *** these three factors,we conducted a user study to investigate the effectiveness of variable degrees of guidance with respect to the user’s previous knowledge in different analysis *** results shed light on the appropriateness of certain degrees of guidance in relation to different tasks,and the overall influence of guidance on the analysis outcome in terms of user’s mental state and analysis performance.
Highlights•Real-world evidence in oncology is evolving rapidly with many particularities. •This guidance provides key recommendations for reporting real-world evidence studies in oncology. •Recommendations are based o...
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Highlights•Real-world evidence in oncology is evolving rapidly with many particularities. •This guidance provides key recommendations for reporting real-world evidence studies in oncology. •Recommendations are based on a review of current evidence and the authors’ collective expert opinion. •Authors are a multidisciplinary group of experts from different institutions and countries. •guidance is provided for full article development, including title, introduction, methods, results, discussion, conclusion.
On March 3, 2021, the White House released an Interim National Security Strategic guidance (INSSG). This is the first time an administration has issued interim guidance; previous administrations refrained from issuing...
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On March 3, 2021, the White House released an Interim National Security Strategic guidance (INSSG). This is the first time an administration has issued interim guidance; previous administrations refrained from issuing formal guidance that articulated strategic intent until producing the congressionally mandated National Security Strategy (NSS) (originating in the Goldwater-Nichols Department of Defense Reorganization Act of 1986 P.L. 99-433, section 603/50 U.S.C section 3043). The full NSS is likely to be released later in 2021 or early 2022. The INSSG states the Biden Administrations conceptual approach to national security matters as well as signaling its key priorities, particularly as executive branch departments and agencies prepare their Fiscal Year (FY) 2022 budget submissions. With respect to the latter, FY2022 will be the first budget prepared after the expiration of the budget caps required under the Budget Control Act (BCA) of 2011. Details regarding how the Administrations conceptual approach will be implemented across different regions and functional issues are likely to be expressed in the full NSS.
BACKGROUND Percutaneous endoscopic lumbar discectomy(PELD)has become a mature and mainstream minimally invasive surgical technique for treating lumbar disc herniation(LDH).Repeated fluoroscopy,with more than 30 shots ...
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BACKGROUND Percutaneous endoscopic lumbar discectomy(PELD)has become a mature and mainstream minimally invasive surgical technique for treating lumbar disc herniation(LDH).Repeated fluoroscopy,with more than 30 shots on average,is inevitable to ensure its accuracy and ***,exposure to X-rays may pose a threat to human *** herein report a case of ultrasound(US)-assisted PELD in two levels of LDH to explore a new possibility that can reduce the radiation dose during puncture and cannulation in *** SUMMARY A 38-year-old man with low back pain and left leg pain for more than 7 years came to our clinic,his symptoms had aggravated for 1 month,and he was diagnosed with L3-4 and L4-5 disc *** received US-guided PELD with good results:His straight leg elevation increased from 40 to 90 degrees after PELD,and his visual analog scale(VAS)and Oswestry Disability Index scores both significantly decreased immediately and 6 mo after *** the guidance of US,he received only two shots of fluoroscopy(fluoroscopic time:4.4 s;radiation dose:3.98 mGy).To our knowledge,this is the first case of US-guided puncture and cannulation of PELD for LDH at two *** US could be used to guide PELD and has the potential to largely reduce radiation than traditional X-ray guidance.
Biography Boris Gorovits is a Senior Director of the Bioanalytical lab at Pfizer. Boris earned his PhD in Enzymology from the Moscow State University and later completed postdoctoral research studies in protein biophy...
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Biography Boris Gorovits is a Senior Director of the Bioanalytical lab at Pfizer. Boris earned his PhD in Enzymology from the Moscow State University and later completed postdoctoral research studies in protein biophysics at the Medical Center, University of Texas at San Antonio, TX, USA. In 2000, Boris joined Wyeth Research (later Pfizer Inc) to work as a bioanalytical group lead with a growing scope of responsibilities. Currently, he leads the Bioanalytical group within Biomedicine Design department which is responsible for many aspects of the Regulated and Nonregulated Bioanalytical support for the pan-Pfizer Biotherapeutic portfolio. Boris co-chairs Pfizer internal Immunogenicity Expert Working Group, which is responsible for review of the biotherapeutic immunogenicity risk assessment and mitigation strategies. Recently, Boris has been actively involved in industry discussions focusing on PK and immunogenicity assessment, bioanalytical support of various biotherapeutic modalities, including mAbs, bi-specific antibodies, antibody-drug conjugates, ADCs and gene therapy. Boris is proud to be an active member of the American Association of Pharma Scientists. This interview was conducted by Sankeetha Nadarajah, Managing Commissioning Editor of Bioanalysis, at the AAPS ICH-M10 Public Consultation Workshop (Silver Spring, MD, USA), 11 June 2019.
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