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Off-Label Prescription and How it is (Not) Regulated in China
Vera Lúcia C. Raposo 이화여자대학교 생명의료법연구소 2017 Asia Pacific Journal of Health Law & Ethics Vol.10 No.3
Off-label prescription—the use of a drug outside the scope of its marketing authorization (MA) and the content of its summary of product characteristics (SmPC)—is a medical practice spread all around the world, China being no exception. Several reasons, mostly related to financial strategies from pharmaceutical companies, can justify the decision of not requiring an MA for a certain drug use. The main reason is the purpose of having a profit without taking excessive risks, either economic or legal. This paper will define off-label prescription, discuss the various reasons leading to it, describe the general framework of this practice in Europe and in the United States and analyze off-label prescription in China, describe its regulation (actually, the lack of it) in the Chinese legal system and comment on the actual practice by Chinese health care providers. To conclude, the paper will sustain that a regulation for off-label prescription is essential to clarify for doctors the requirements of lawful off-label uses, and thus protect patients from injuries resulting from risky of-label prescriptions.
Off-Label Prescription and How it is (Not) Regulated in China
Vera Lú,cia C. Raposo 이화여자대학교 생명의료법연구소 2017 Asia Pacific Journal of Health Law & Ethics Vol.10 No.3
Off-label prescription—the use of a drug outside the scope of its marketing authorization (MA) and the content of its summary of product characteristics (SmPC)—is a medical practice spread all around the world, China being no exception. Several reasons, mostly related to financial strategies from pharmaceutical companies, can justify the decision of not requiring an MA for a certain drug use. The main reason is the purpose of having a profit without taking excessive risks, either economic or legal. This paper will define off-label prescription, discuss the various reasons leading to it, describe the general framework of this practice in Europe and in the United States and analyze off-label prescription in China, describe its regulation (actually, the lack of it) in the Chinese legal system and comment on the actual practice by Chinese health care providers. To conclude, the paper will sustain that a regulation for off-label prescription is essential to clarify for doctors the requirements of lawful off-label uses, and thus protect patients from injuries resulting from risky of-label prescriptions.
Rodrigues, B.,Peinado, J.M.,Raposo, S.,Constantino, A.,Quintas, C.,Lima-Costa, M.E. The Korean Society for Microbiology and Biotechnol 2015 Journal of microbiology and biotechnology Vol.25 No.6
Carob waste is a useful raw material for the second-generation ethanol because 50% of its dry weight is sucrose, glucose, and fructose. To optimize the process, we have studied the influence of the initial concentration of sugars on the fermentation performance of Saccharomyces cerevisiae. With initial sugar concentrations (S<sub>0</sub> ) of 20 g/l, the yeasts were derepressed and the ethanol produced during the exponential phase was consumed in a diauxic phase. The rate of ethanol consumption decreased with increasing S<sub>0</sub> and disappeared at 250 g/l when the Crabtree effect was complete and almost all the sugar consumed was transformed into ethanol with a yield factor of 0.42 g/g. Sucrose hydrolysis was delayed at high S<sub>0</sub> because of glucose repression of invertase synthesis, which was triggered at concentrations above 40 g/l. At S<sub>0</sub> higher than 250 g/l, even when glucose had been exhausted, sucrose was hydrolyzed very slowly, probably due to an inhibition at this low water activity. Although with lower metabolic rates and longer times of fermentation, 250 g/l is considered the optimal initial concentration because it avoids the diauxic consumption of ethanol and maintains enough invertase activity to consume all the sucrose, and also avoids the inhibitions due to lower water activities at higher S<sub>0</sub> .
Blow up of solutions for a Petrovsky type equation with logarithmic nonlinearity
Jorge Ferreira,Nazli Irkil,Erhan Piskin,Carlos Raposo,Mohammad Shahrouzi 대한수학회 2022 대한수학회보 Vol.59 No.6
This paper aims to investigate the initial boundary value problem of the nonlinear viscoelastic Petrovsky type equation with nonlinear damping and logarithmic source term. We derive the blow-up results by the combination of the perturbation energy method, concavity method, and differential-integral inequality technique.
Offner, Fritz,Samoilova, Olga,Osmanov, Evgenii,Eom, Hyeon-Seok,Topp, Max S.,Raposo, Joã,o,Pavlov, Viacheslav,Ricci, Deborah,Chaturvedi, Shalini,Zhu, Eugene,van de Velde, Helgi,Enny, Christopher American Society of Hematology 2015 Blood Vol.126 No.16
<P>This phase 2 study evaluated whether substituting bortezomib for vincristine in frontline rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) therapy could improve efficacy in non-germinal center B-cell-like diffuse large B-cell lymphoma (non-GCB DLBCL), centrally confirmed by immunohistochemistry (Hans method). In total, 164 patients were randomized 1:1 to receive six 21-day cycles of rituximab 375 mg/m<SUP>2</SUP>, cyclophosphamide 750 mg/m<SUP>2</SUP>, and doxorubicin 50 mg/m<SUP>2</SUP>, all IV day 1, prednisone 100 mg/m<SUP>2</SUP> orally days 1-5, plus either bortezomib 1.3 mg/m<SUP>2</SUP> IV days 1, 4, 8, 11 (rituximab, cyclophosphamide, doxorubicin, and prednisone with bortezomib [VR-CAP]; n = 84) or vincristine 1.4 mg/m<SUP>2</SUP> (maximum 2 mg) IV day 1 (R-CHOP; n = 80). There were no significant differences between VR-CAP and R-CHOP in complete response rate (64.5%, 66.2%; odds ratio [OR], 0.91; <I>P</I> = .80), overall response rate (93.4%, 98.6%; OR, 0.21; <I>P</I> = .11), progression-free survival (hazard ratio [HR], 1.12; <I>P</I> = .76), or overall survival (HR, 0.89; <I>P</I> = .75). Rates of grade ≥3 adverse events (AEs; 88%, 89%), serious AEs (38%, 34%), discontinuations due to AEs (7%, 3%), and deaths due to AEs (2%, 5%) were similar with VR-CAP and R-CHOP. Grade ≥3 peripheral neuropathy rates were 6% and 3%, respectively. VR-CAP did not improve efficacy vs R-CHOP in non-GCB DLBCL. This trial was registered at www.clinicaltrials.gov as #NCT01040871.</P>