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See detailQuality assurance in the 22991 EORTC ROG trial in localized prostate cancer: Dummy run and individual case review
Matzinger, O.; Poortmans, P.; Giraud, J.-Y. et al

in Radiotherapy & Oncology (2009), 90(3), 285-290

Introduction: EORTC trial 22991 was designed to evaluate the addition of concomitant and adjuvant short-term hormonal treatments to curative radiotherapy in terms of disease-free survival for patients ... [more ▼]

Introduction: EORTC trial 22991 was designed to evaluate the addition of concomitant and adjuvant short-term hormonal treatments to curative radiotherapy in terms of disease-free survival for patients with intermediate risk localized prostate cancer. In order to assess the compliance to the 3D conformal radiotherapy protocol guidelines, all participating centres were requested to participate in a dummy run procedure. An individual case review was performed for the largest recruiting centres as well. Materials and methods: CT-data of an eligible prostate cancer patient were sent to 30 centres including a description of the clinical case. The investigator was requested to delineate the volumes of interest and to perform treatment planning according to the protocol. Thereafter, the investigators of the 12 most actively recruiting centres were requested to provide data on five randomly selected patients for an individual case review. Results: Volume delineation varied significantly between investigators. Dose constraints for organs at risk (rectum, bladder, hips) were difficult to meet. In the individual case review, no major protocol deviations were observed, but a number of dose reporting problems were documented for centres using IMRT. Conclusions: Overall, results of this quality assurance program were satisfactory. The efficacy of the combination of a dummy run procedure with an individual case review is confirmed in this study, as none of the evaluated patient files harboured a major protocol deviation. Quality assurance remains a very important tool in radiotherapy to increase the reliability of the trial results. Special attention should be given when designing quality assurance programs for more complex irradiation techniques. © 2008 Elsevier Ireland Ltd. All rights reserved. [less ▲]

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See detailQuality assurance in the EORTC 22033-26033/CE5 phase III randomized trial for low grade glioma: The digital individual case review
Fairchild, A.; Weber, D. C.; Bar-Deroma, R. et al

in Radiotherapy & Oncology (2012), 103(3), 287-292

Introduction: The phase III EORTC 22033-26033/NCIC CE5 intergroup trial compares 50.4 Gy radiotherapy with up-front temozolomide in previously untreated low-grade glioma. We describe the digital EORTC ... [more ▼]

Introduction: The phase III EORTC 22033-26033/NCIC CE5 intergroup trial compares 50.4 Gy radiotherapy with up-front temozolomide in previously untreated low-grade glioma. We describe the digital EORTC individual case review (ICR) performed to evaluate protocol radiotherapy (RT) compliance. Methods: Fifty-eight institutions were asked to submit 1-2 randomly selected cases. Digital ICR datasets were uploaded to the EORTC server and accessed by three central reviewers. Twenty-seven parameters were analysed including volume delineation, treatment planning, organ at risk (OAR) dosimetry and verification. Consensus reviews were collated and summary statistics calculated. Results: Fifty-seven of seventy-two requested datasets from forty-eight institutions were technically usable. 31/57 received a major deviation for at least one section. Relocation accuracy was according to protocol in 45. Just over 30% had acceptable target volumes. OAR contours were missing in an average of 25% of cases. Up to one-third of those present were incorrectly drawn while dosimetry was largely protocol compliant. Beam energy was acceptable in 97% and 48 patients had per protocol beam arrangements. Conclusions: Digital RT plan submission and review within the EORTC 22033-26033 ICR provide a solid foundation for future quality assurance procedures. Strict evaluation resulted in overall grades of minor and major deviation for 37% and 32%, respectively. © 2012 Elsevier Ireland Ltd. All rights reserved. [less ▲]

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See detailQuality assurance of the EORTC 22043-30041 trial in post-operative radiotherapy in prostate cancer: Results of the Dummy Run procedure
Fenton, P. A.; Hurkmans, C.; GULYBAN, Akos ULg et al

in Radiotherapy & Oncology (2013)

Background and purpose: The EORTC 22043-30041 trial investigates the role of the addition of androgen suppression to post-operative radiotherapy in patients who have undergone radical prostatectomy. As ... [more ▼]

Background and purpose: The EORTC 22043-30041 trial investigates the role of the addition of androgen suppression to post-operative radiotherapy in patients who have undergone radical prostatectomy. As part of the quality assurance of radiotherapy (QART) a Dummy Run (DR) procedure was performed. Materials and method: The protocol included detailed and published delineation guidelines. Participating institutions digitally submitted radiotherapy treatment volumes and a treatment plan for a standard clinical case. Submissions were centrally reviewed using the VODCA software platform. Results: Thirty-eight submissions from thirty-one institutions were reviewed. Six were accepted without comments. Twenty-three were accepted with comments on one or more items: target volume delineation (22), OAR delineation (23), planning and dosimetry (3) or treatment verification (1). Nine submissions were rejected requiring resubmission, seven for target volume delineation reasons alone. Intervention to highlight the importance of delineation guidelines was made prior to the entry of the first patient in the trial. After this, a lower percentage of resubmissions was required. Conclusions: The EORTC 22043-30041 Dummy Run highlights the need for timely and effective QART in clinical trials. The variation in target volume and OAR definition demonstrates that clinical guidelines and radiotherapy protocols are not a substitute for QART procedures. Early intervention in response to the Dummy Run improved protocol understanding. © 2013 Elsevier Ireland Ltd. All rights reserved. [less ▲]

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See detailQuality assurance: experience of an university
Chapelle, Jean-Paul ULg

Conference (2000, September 26)

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See detailQuality by design compliant analytical method validation
Rozet, Eric ULg; Ziemons, Eric ULg; Marini Djang'Eing'A, Roland ULg et al

in Analytical Chemistry (2012), 84

The concept of quality by design (QbD) has recently been adopted for the development of pharmaceutical processes to ensure a predefined product quality. Focus on applying the QbD concept to analytical ... [more ▼]

The concept of quality by design (QbD) has recently been adopted for the development of pharmaceutical processes to ensure a predefined product quality. Focus on applying the QbD concept to analytical methods has increased as it is fully integrated within pharmaceutical processes and especially in the process control strategy. In addition, there is the need to switch from the traditional checklist implementation of method validation requirements to a method validation approach that should provide a high level of assurance of method reliability in order to adequately measure the Critical Quality Attributes (CQAs) of the drug product. The intended purpose of analytical methods is directly related to the final decision that will be made with the results generated by these methods under study. The final aim for quantitative impurity assays is to correctly declare a substance or a product as compliant with respect to the corresponding product specifications. For content assays, the aim is similar: making the correct decision about product compliance with respect to their specification limits. It is for these reasons that the fitness of these methods should be defined, as they are key elements of the Analytical Target Profile (ATP). Therefore, validation criteria, corresponding acceptance limits and method validation decision approaches should be settled in accordance with the final use of these analytical procedures. This work proposes a general methodology to achieve this in order to align method validation within the QbD framework and philosophy. β-expectation tolerance intervals are implemented to decide about the validity of analytical methods. The proposed methodology is also applied to the validation of analytical procedures dedicated to the quantification of impurities or active product ingredients (API) in drug substances or drug products and its applicability is illustrated with two case studies. [less ▲]

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See detailQUALITY BY DESIGN COMPLIANT METHOD VALIDATION
Rozet, Eric ULg; Boulanger, B.; Hubert, Philippe ULg

Poster (2012, February)

Analytical method validation is a mandatory step to evaluate the ability of developed methods to provide accurate results for their routine application in order to trust the critical decisions that will ... [more ▼]

Analytical method validation is a mandatory step to evaluate the ability of developed methods to provide accurate results for their routine application in order to trust the critical decisions that will be made with them. Even if several guidelines exist to help perform analytical method validations (ICH Q2R1 [1], USP <1225> [2], …) there is still the need to clarify the meaning and interpretation of analytical method validation criteria and methodology. Indeed, actually method validation is mostly realised as the traditional check list implementation of e.g. the ICH Q2R1 or USP <1225> method validation requirements. However, within the trend of Quality by Design [3], there is the need to switch from this traditional vision to an analytical method validation really adding value and providing a high level of assurance of analytical methods results reliability. Yet, different interpretations can be made of the validation guidelines as well as for the definitions of the validation criteria. This will lead to diverse experimental designs implemented to try fulfilling these criteria. Finally, different decision methodologies can also be interpreted from these guidelines. Therefore, the risk that a validated analytical method may be unfit for its future purpose will depend on a personal interpretation of these guidelines. The objective of this presentation is thus to show that analytical method validation should be planned and performed by first starting with the end in mind: what is the objective of the analytical methods under study? In such a way analytical method validation is coherent with the actual Quality by Design regulatory expectations. The risk of having validated an analytical method unfit for its purpose is strongly reduced as well as the risk of generating Out of Specification (OOS) results due to an unfit method. References [1] International Conference on Harmonisation (ICH) of Technical Requirements for registration of Pharmaceuticals for Human Use, Topic Q2 (R1): Validation of Analytical Procedures: Text and Methodology, Geneva, 2005. [2] USP 33 NF 28 S1, U.S. Pharmacopeia, 2007. USP–NF General Chapter <1225>. [3] International Conference on Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use, Topic Q8(R2): Pharmaceutical development, Geneva, 2009. [less ▲]

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See detailQuality characteristics and oxidative stability of date seed oil during storage
Besbes, S.; Blecker, Christophe ULg; Deroanne, Claude et al

in Food Science & Technology International (2004), 10(5), 333-338

Studies were conducted on some quality characteristics of date seed oil from two date palm cultivars (Phoenix dactylifera L.): Deglet Nour and Allig. The following values were obtained for Deglet Nour and ... [more ▼]

Studies were conducted on some quality characteristics of date seed oil from two date palm cultivars (Phoenix dactylifera L.): Deglet Nour and Allig. The following values were obtained for Deglet Nour and Allig cultivars respectively: unsaponifiable matter 8.92-7.76%, iodine value 45.49-44.08, total phenols 520.81-220.32 mug/g oil, chlorophylls 0.86-0.58 mug/g oil, viscosity 18.50-20.50 mPa.s, refractive index 1.457-1.462, acidity 1.06-2.10mg KOH/g oil and peroxide index 16.00-25.00 meq O-2/100g oil. Lipid fractionation of date seed oil yielded 98.30-97.30% neutral lipids, 97.26-96.90% triglycerides, 0.25-0.18% phospholipids and 0.36-0.31% sterols. Gas-liquid chromatography revealed that the major unsaturated fatty acid was oleic acid (39.17-42.13%) while the main saturated fatty acid was lauric acid (24.34-22.56%). Date seed oil showed high medium molecular weight triglycerides (C32-C42, about 27%). Extinction coefficients at 232 nm and 270 nm increased slightly during 40 days in oven (60degreesC) showing that date seed oil could be easily stored. The production of oil from date seeds provides the use of a renewable resource, and at the same time adding value to agricultural products. [less ▲]

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See detailQuality characteristics and oxydative stability of date seed oil during storage.
Besbes, Souhail; Blecker, Christophe ULg; Deroanne, Claude et al

in Food Science & Technology International (2004), 10(5), 333-338

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See detailQuality characteristics of marketed eggs in Basse Kabylie (Algeria)
Moula, Nassim ULg; Philippe, François-Xavier ULg; Ait Kaki, Asma ULg et al

Poster (2012, October 19)

Quality variations of retailed eggs are widely reported. This study aims at assessing the quality of eggs according to the marketing channel in the department of Bejaia (Algeria). In spring and summer ... [more ▼]

Quality variations of retailed eggs are widely reported. This study aims at assessing the quality of eggs according to the marketing channel in the department of Bejaia (Algeria). In spring and summer 2012, a total of 3330 eggs were bought in 30 stores divided into 3 categories: 10 supermarkets (1146 eggs), 10 public markets (1048 eggs), and 10 shops (1136 eggs). The eggs weights differed significantly with the marketing channel with 58.9±0.14, 61.2±0.13 and 62.8±0.13 g for public markets, shops and supermarkets, respectively (p<0.001). Although the shell thickness was similar for all marketing channels, the proportion of damaged eggs was higher in public markets (9.0%), intermediate in shops (7.3%) and lower in supermarkets (5.7%; p<0.05). The yolk/albumen ratio was significantly higher for eggs from supermarkets (48.1%) compared to the other channels (around 47.4%; p<0.05). The freshness of the eggs, measured by the Haugh method, was lower in public markets (74.3 units), intermediate in shops (77.6 units) and higher in supermarkets (79.9 units; p<0.05). The price of eggs, expressed in Algerian Dinar (AD) per kg, was significantly lower in public markets (124 AD/kg) compared to the two other channels (around 131 AD/kg; p<0.05). One can conclude that egg quality in Basse Kabylie differs significantly between marketing channels with higher quality observed in supermarkets. The lower quality of eggs in public markets is associated with lower price. Eggs from shops present an intermediate quality. A one-year study would allow studying both the potential seasonal effect and compare intrinsic variability across marketing channels. [less ▲]

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See detailQuality characteristics of sesame seeds and by-products
Elleuch, Mohamed; Besbes, Souhail; Roiseux, Olivier et al

in Food Chemistry (2007), 103(2), 641-650

The chemical composition, of raw sesame seed (RS); Sesame coats 1 (SC1) and sesame coats 2 (SC2) obtained as a by-product respectively after dehulling and roasting processes during preparation of sesame ... [more ▼]

The chemical composition, of raw sesame seed (RS); Sesame coats 1 (SC1) and sesame coats 2 (SC2) obtained as a by-product respectively after dehulling and roasting processes during preparation of sesame paste (tehineh) for the manufacturing of Halaweh (sweetened tehineh), was determined along with the physicochemical characteristics of the oil fraction. Compared to RS, SC1 and SC2 showed higher amounts of dietary fibre, ash and polyphenol and lower amounts of oil and protein. Oil from SC1 and SC2, had a higher content of free fatty acids, chlorophylls, polyphenols and sesamol than RS oil. SC2 oil showed more intense colour, more absorbance in UV-A, UV-B and UV-C ranges and a significant higher viscosity (P < 0.05). No differences (P > 0.05) were observed for refractive index, iodine value and fatty acids composition. This latter was essentially dominated by oleic and linoleic acids. Oxidative stability of oil was investigated using a Rancimat system and in an oven test at 65 degrees C over 60 days. RS oil was more resistant to the thermal treatment during a long period than SC1 and SC2 oils. (c) 2006 Elsevier Ltd. All rights reserved. [less ▲]

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See detailQuality control of Citri reticulatae pericarpium: Exploratory analysis and discrimination.
Tistaert, Christophe; Thierry, Line; Szandrach, Andrzej et al

in Analytica Chimica Acta (2011), 705(1-2), 111-22

Extracts of Citri reticulatae pericarpium (PCR) are commonly used in the Traditional Chinese Medicine. The quality control of PCR is currently performed by single marker analysis, which can hardly ... [more ▼]

Extracts of Citri reticulatae pericarpium (PCR) are commonly used in the Traditional Chinese Medicine. The quality control of PCR is currently performed by single marker analysis, which can hardly describe the complexity of such natural samples. In this study, a fingerprint methodology for PCR based on high-performance liquid chromatography (HPLC) was developed and validated. A total of 69 fingerprints of authenticated PCR samples, commercial PCR samples, mixed peel samples, and other Citrus peels were recorded. Exploratory data analysis allowed optimizing the extraction procedure and detecting mixed peel samples. Once the optimizations were performed and the method validated, discrimination between the authentic PCR samples and all other samples was performed by p-Discriminant Partial Least Squares. The established model was able to differentiate between classes with a high reliability for each sample. Furthermore, evaluation of the score and loading plots of the model indicated nobiletin, tangeretin, naringin and hesperidin as important markers for the quality control of PCR. [less ▲]

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See detailQuality control of particulate materials through image analysis.
Pirard, Eric ULg

in Optics and Industrial Vision (2004)

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See detailQuality controls of no-carrier-added aromatic amino acids such as FDOPA and FTYR produced at curie level
Libert, Lionel ULg; Lemaire, Christian ULg; Giacomelli, Fabrice ULg et al

Poster (2013, May)

Aromatic fluoro amino acids such as 2-[18F]fluoro-L-tyrosine (FTYR) and 6-[18F]fluoro-L-DOPA (FDOPA) are useful radiopharmaceuticals for oncologic studies and evaluation of the presynaptic dopaminergic ... [more ▼]

Aromatic fluoro amino acids such as 2-[18F]fluoro-L-tyrosine (FTYR) and 6-[18F]fluoro-L-DOPA (FDOPA) are useful radiopharmaceuticals for oncologic studies and evaluation of the presynaptic dopaminergic function using positron emission tomography. Recently, a no-carrier-added (nca) enantioselective synthesis of these compounds, based on an multistep PTC approach was automated in a FASTlabTM module from GE . From 185 GBq of [18F]fluoride and after 1 hour of synthesis, more than 37 GBq of FTYR or FDOPA are available . This automated production yields enough doses for many PET studies. A monograph for FDOPA prepared by electrophilic substitution exists , but it is not adapted to the nca nucleophilic synthesis of FDOPA and FTYR, as in this case specific activity, by products and possible impurities are different. A complete quality control (QC) has then be developed in accordance with the guidelines of the European Pharmacopeia (Eur. Ph.). [less ▲]

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See detailQuality criteria to assess the implementation of a local group of security promotion
Lechien, Xavier; Vandoorne, Chantal ULg; Bantuelle, Martine et al

in Bouwman, L. I.; Boonekamp, G. M. M.; Koelen, M. A. (Eds.) Proceedings of the International conference on Health Promotion and Nutrition (1997)

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See detailQuality evaluation - A challenge for online courses and catalogues
Poumay, Marianne ULg

in Gard, Ellen (Ed.) EMDEL : A model for valorization of eLearning in a knowledge society (2005)

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