26 research outputs found
Vrednovanje analitičkih metoda i laboratorijskih postupaka u kemijskim mjerenjima
Method validation is a key element in the establishment of reference methods and in the assessment of a laboratory’s competence in producing reliable analytical data. Hence, the scope of the term »method validation« is wide, especially if one bears in mind the role of Quality Assurance/Quality Control (QA/QC). The paper puts validation in the context of the process generating chemical information, introduces basic performance parameters included in the validation processes, and evaluates current approaches to the problem.
Two cases are presented in more detail: the development of European standard for chlorophenols and its validation by a full scale collaborative trial and the intralaboratory validation of a method for ethylenethiourea (ETU) by using alternative analytical techniques.Vrednovanje metoda ključni je postupak u utvrđivanju referentnih metoda i procjeni kompetencije laboratorija da proizvodi pouzdane rezultate analiza. Stoga je značenje širine okvira ovog termina posebice važno jer valja imati na umu i ulogu osiguranja kakvoće i kontrole kakvoće.
Autori stavljaju postupak vrednovanja metoda u kontekst proizvodnje kemijskoanalitičkih podataka, upoznaju čitatelja s osnovnim parametrima pri ocjeni uspješnosti te ocjenjuju trenutne pristupe ovom problemu.
U dva je primjera posebna pozornost posvećena razvoju europske norme za klorofenole i njezinoj ocjeni opsežnim pokusom te unutarlaboratorijskom potvrdom metode za određivanje etilentioureje rabeći alternativne analitičke tehnike
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Efficacy of management and monitoring methods to prevent post-harvest losses caused by rodents
The presence of pest rodents around food production and storage sites is one of many underlying problems contributing to food contamination and loss, particularly influencing food and nutrition security in low-income countries. By reducing both pre- and post-harvest losses by rodents, millions of food-insecure people would benefit. As there are limited quantitative data on post-harvest rice losses due to rodents, our objectives were to assess stored rice losses in local households from eight rural communities and two rice milling factories in Bangladesh and to monitor the effect of different rodent control strategies to limit potential losses. Four treatments were applied in 2016 and 2017, (i) untreated control, (ii) use of domestic cats, (iii) use of rodenticides, (iv) use of snap-traps. In total, over a two-year period, 210 rodents were captured from inside people’s homes, with Rattus rattus trapped most often (n = 91), followed by Mus musculus (n = 75) and Bandicota bengalensis (n = 26). In the milling stations, 68 rodents were trapped, of which 21 were M. musculus, 19 R. rattus, 17 B. bengalensis, 8 Rattus exulans, and 3 Mus terricolor. In 2016, losses from standardised baskets of rice within households were between 13.6% and 16.7%. In 2017, the losses were lower, ranging from 0.6% to 2.2%. Daily rodent removal by trapping proved to be most effective to diminish stored produce loss. The effectiveness of domestic cats was limited
Vrednovanje analitičkih metoda i laboratorijskih postupaka u kemijskim mjerenjima
Method validation is a key element in the establishment of reference methods and in the assessment of a laboratory’s competence in producing reliable analytical data. Hence, the scope of the term »method validation« is wide, especially if one bears in mind the role of Quality Assurance/Quality Control (QA/QC). The paper puts validation in the context of the process generating chemical information, introduces basic performance parameters included in the validation processes, and evaluates current approaches to the problem.
Two cases are presented in more detail: the development of European standard for chlorophenols and its validation by a full scale collaborative trial and the intralaboratory validation of a method for ethylenethiourea (ETU) by using alternative analytical techniques.Vrednovanje metoda ključni je postupak u utvrđivanju referentnih metoda i procjeni kompetencije laboratorija da proizvodi pouzdane rezultate analiza. Stoga je značenje širine okvira ovog termina posebice važno jer valja imati na umu i ulogu osiguranja kakvoće i kontrole kakvoće.
Autori stavljaju postupak vrednovanja metoda u kontekst proizvodnje kemijskoanalitičkih podataka, upoznaju čitatelja s osnovnim parametrima pri ocjeni uspješnosti te ocjenjuju trenutne pristupe ovom problemu.
U dva je primjera posebna pozornost posvećena razvoju europske norme za klorofenole i njezinoj ocjeni opsežnim pokusom te unutarlaboratorijskom potvrdom metode za određivanje etilentioureje rabeći alternativne analitičke tehnike
Oral Abstracts 7: RA ClinicalO37. Long-Term Outcomes of Early RA Patients Initiated with Adalimumab Plus Methotrexate Compared with Methotrexate Alone Following a Targeted Treatment Approach
Background: This analysis assessed, on a group level, whether there is a long-term advantage for early RA patients treated with adalimumab (ADA) + MTX vs those initially treated with placebo (PBO) + MTX who either responded to therapy or added ADA following inadequate response (IR). Methods: OPTIMA was a 78- week, randomized, controlled trial of ADA + MTX vs PBO + MTX in MTX-naïve early (<1 year) RA patients. Therapy was adjusted at week 26: ADA + MTX-responders (R) who achieved DAS28 (CRP) <3.2 at weeks 22 and 26 (Period 1, P1) were re-randomized to withdraw or continue ADA and PBO + MTX-R continued randomized therapy for 52 weeks (P2); IR-patients received open-label (OL) ADA + MTX during P2. This post hoc analysis evaluated the proportion of patients at week 78 with DAS28 (CRP) <3.2, HAQ-DI <0.5, and/or ΔmTSS ≤0.5 by initial treatment. To account for patients who withdrew ADA during P2, an equivalent proportion of R was imputed from ADA + MTX-R patients. Results: At week 26, significantly more patients had low disease activity, normal function, and/or no radiographic progression with ADA + MTX vs PBO + MTX (Table 1). Differences in clinical and functional outcomes disappeared following additional treatment, when PBO + MTX-IR (n = 348/460) switched to OL ADA + MTX. Addition of OL ADA slowed radiographic progression, but more patients who received ADA + MTX from baseline had no radiographic progression at week 78 than patients who received initial PBO + MTX. Conclusions: Early RA patients treated with PBO + MTX achieved comparable long-term clinical and functional outcomes on a group level as those who began ADA + MTX, but only when therapy was optimized by the addition of ADA in PBO + MTX-IR. Still, ADA + MTX therapy conferred a radiographic benefit although the difference did not appear to translate to an additional functional benefit. Disclosures: P.E., AbbVie, Merck, Pfizer, UCB, Roche, BMS—Provided Expert Advice, Undertaken Trials, AbbVie—AbbVie sponsored the study, contributed to its design, and participated in the collection, analysis, and interpretation of the data, and in the writing, reviewing, and approval of the final version. R.F., AbbVie, Pfizer, Merck, Roche, UCB, Celgene, Amgen, AstraZeneca, BMS, Janssen, Lilly, Novartis—Research Grants, Consultation Fees. S.F., AbbVie—Employee, Stocks. A.K., AbbVie, Amgen, AstraZeneca, BMS, Celgene, Centocor-Janssen, Pfizer, Roche, UCB—Research Grants, Consultation Fees. H.K., AbbVie—Employee, Stocks. S.R., AbbVie—Employee, Stocks. J.S., AbbVie, Amgen, AstraZeneca, BMS, Celgene, Centocor-Janssen, GlaxoSmithKline, Lilly, Pfizer (Wyeth), MSD (Schering-Plough), Novo-Nordisk, Roche, Sandoz, UCB—Research Grants, Consultation Fees. R.V., AbbVie, BMS, GlaxoSmithKline, Human Genome Sciences, Merck, Pfizer, Roche, UCB Pharma—Consultation Fees, Research Support. Table 1.Week 78 clinical, functional, and radiographic outcomes in patients who received continued ADA + MTX vs those who continued PBO + MTX or added open-label ADA following an inadequate response ADA + MTX, n/N (%)a PBO + MTX, n/N (%)b Outcome Week 26 Week 52 Week 78 Week 26 Week 52 Week 78 DAS28 (CRP) <3.2 246/466 (53) 304/465 (65) 303/465 (65) 139/460 (30)*** 284/460 (62) 300/460 (65) HAQ-DI <0.5 211/466 (45) 220/466 (47) 224/466 (48) 150/460 (33)*** 203/460 (44) 208/460 (45) ΔmTSS ≤0.5 402/462 (87) 379/445 (86) 382/443 (86) 330/459 (72)*** 318/440 (72)*** 318/440 (72)*** DAS28 (CRP) <3.2 + ΔmTSS ≤0.5 216/462 (47) 260/443 (59) 266/443 (60) 112/459 (24)*** 196/440 (45) 211/440 (48)*** DAS28 (CRP) <3.2 + HAQ-DI <0.5 + ΔmTSS ≤0.5 146/462 (32) 168/443 (38) 174/443 (39) 82/459 (18)*** 120/440 (27)*** 135/440 (31)** aIncludes patients from the ADA Continuation (n = 105) and OL ADA Carry On (n = 259) arms, as well as the proportional equivalent number of responders from the ADA Withdrawal arm (n = 102). bIncludes patients from the MTX Continuation (n = 112) and Rescue ADA (n = 348) arms. Last observation carried forward: DAS28 (CRP) and HAQ-DI; Multiple imputations: ΔmTSS. ***P < 0.001 and **iP < 0.01, respectively, for differences between initial treatments from chi-squar