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Philippe Hubert - One of the best experts on this subject based on the ideXlab platform.

  • analysis of recent pharmaceutical regulatory documents on Analytical Method validation
    Journal of Chromatography A, 2007
    Co-Authors: Eric Rozet, Cedric Hubert, Bruno Boulanger, Attilio Ceccato, Eric Ziemons, Radu Oprean, Serge Rudaz, Philippe Hubert
    Abstract:

    All analysts face the same situations as Method validation is the process of proving that an Analytical Method is acceptable for its intended purpose. In order to resolve this problem, the analyst refers to regulatory or guidance documents, and therefore the validity of the Analytical Methods is dependent on the guidance, terminology and Methodology, proposed in these documents. It is therefore of prime importance to have clear definitions of the different validation criteria used to assess this validity. It is also necessary to have Methodologies in accordance with these definitions and consequently to use statistical Methods which are relevant with these definitions, the objective of the validation and the objective of the Analytical Method. The main purpose of this paper is to outline the inconsistencies between some definitions of the criteria and the experimental procedures proposed to evaluate those criteria in recent documents dedicated to the validation of Analytical Methods in the pharmaceutical field, together with the risks and problems when trying to cope with contradictory, and sometimes scientifically irrelevant, requirements and definitions.

  • analysis of recent pharmaceutical regulatory documents on Analytical Method validation
    Journal of Chromatography A, 2007
    Co-Authors: Eric Rozet, Cedric Hubert, Bruno Boulanger, Attilio Ceccato, Eric Ziemons, Radu Oprean, Serge Rudaz, Philippe Hubert
    Abstract:

    All analysts face the same situations as Method validation is the process of proving that an Analytical Method is acceptable for its intended purpose. In order to resolve this problem, the analyst refers to regulatory or guidance documents, and therefore the validity of the Analytical Methods is dependent on the guidance, terminology and Methodology, proposed in these documents. It is therefore of prime importance to have clear definitions of the different validation criteria used to assess this validity. It is also necessary to have Methodologies in accordance with these definitions and consequently to use statistical Methods which are relevant with these definitions, the objective of the validation and the objective of the Analytical Method. The main purpose of this paper is to outline the inconsistencies between some definitions of the criteria and the experimental procedures proposed to evaluate those criteria in recent documents dedicated to the validation of Analytical Methods in the pharmaceutical field, together with the risks and problems when trying to cope with contradictory, and sometimes scientifically irrelevant, requirements and definitions. (c) 2007 Elsevier B.V. All rights reserved.

  • using total error as decision criterion in Analytical Method transfer
    Chemometrics and Intelligent Laboratory Systems, 2007
    Co-Authors: Walthere Dewe, Patrice Chiap, Eric Rozet, Bruno Boulanger, Bernadette Govaerts, Philippe Hubert
    Abstract:

    An Analytical transfer is a complete process that consists in transferring a validated Analytical Method from a sending laboratory (called sender) to a receiving laboratory (called receiver) after having experimentally demonstrated that it also masters the Method. The decision to transfer an Analytical Method is usually taken based on the combination of two criteria: one about systematic error and one about random errors. These usual criteria, their combination and their limitations are described in this paper. As it is for Method validation, total error-based approaches should be also considered in Method transfer. Two approaches are proposed in order to have a total error-based criterion and to take into account the precision of the true value estimate. In the first approach, a beta-expectation tolerance interval similar to the one used in Method validation is calculated and then compared to acceptance limits around the estimate of the true value. The second approach, found as slightly more powerful than the first one, consists in estimating the probability to have a result outside these acceptance limits. (c) 2006 Elsevier B.V. All rights reserved.

Daining Fang - One of the best experts on this subject based on the ideXlab platform.

  • Analytical Method to determine flexoelectric coupling coefficient at nanoscale
    arXiv: Materials Science, 2016
    Co-Authors: Hao Zhou, Jiawang Hong, Yongmao Pei, Daining Fang
    Abstract:

    Flexoelectricity is defined as the coupling between strain gradient and polarization, which is expected to be remarkable at nanoscale. However, measuring the flexoelectricity at nanoscale is challenging. In the present work, an Analytical Method for measuring the flexoelectric coupling coefficient based on nanocompression technique is proposed. It is found that the flexoelectricity can induce stiffness softening of dielectric nano-cone-frustum. This phenomenon becomes more significant when the sample size decreases or the half cone angle increases. This Method avoids measuring the electric polarization or current at nanoscale with dynamical loading, which can be beneficial to the flexoelectric measurement at nanoscale and design of flexoelectric nanodevices.

  • Analytical Method to determine flexoelectric coupling coefficient at nanoscale
    Applied Physics Letters, 2016
    Co-Authors: Hao Zhou, Jiawang Hong, Daining Fang
    Abstract:

    Flexoelectricity is defined as the coupling between the strain gradient and polarization, which is expected to be remarkable at nanoscale. However, measuring the flexoelectricity at nanoscale is challenging. In the present work, an Analytical Method for measuring the flexoelectric coupling coefficient based on nanocompression technique is proposed. It is found that the flexoelectricity can induce stiffness softening of the dielectric nano-cone-frustum. This phenomenon becomes more significant when the sample size decreases or the half cone angle increases. This Method avoids measuring the electric polarization or current at nanoscale with dynamical loading, which can be beneficial to the flexoelectricmeasurement at nanoscale and design of flexoelectric nanodevices.

Jun Gong - One of the best experts on this subject based on the ideXlab platform.

  • Analytical Method for magnetic field of eccentric magnetic harmonic gear
    IEEE Access, 2020
    Co-Authors: Libing Jing, Jun Gong
    Abstract:

    Eccentric magnetic harmonic gears (EMHG) can achieve high speed ratio transmission and large torque output by modulating the air gap length between permanent magnets (PM). The Analytical Method is based on the boundary perturbation Method. The vector magnetic potential perturbation equation in the air gap region is established, and the general solution is obtained using the boundary conditions. According to the superposition principle, the air gap flux density of stator and rotor PMs acting alone is synthesized, and the electromagnetic torque and unbalanced magnetic pull are calculated. Last, we compare magnetic field distributions, electromagnetic torque and unbalanced magnetic pull computed by the Analytical Method with those obtained from finite-element Method (FEM).

Eric Rozet - One of the best experts on this subject based on the ideXlab platform.

  • analysis of recent pharmaceutical regulatory documents on Analytical Method validation
    Journal of Chromatography A, 2007
    Co-Authors: Eric Rozet, Cedric Hubert, Bruno Boulanger, Attilio Ceccato, Eric Ziemons, Radu Oprean, Serge Rudaz, Philippe Hubert
    Abstract:

    All analysts face the same situations as Method validation is the process of proving that an Analytical Method is acceptable for its intended purpose. In order to resolve this problem, the analyst refers to regulatory or guidance documents, and therefore the validity of the Analytical Methods is dependent on the guidance, terminology and Methodology, proposed in these documents. It is therefore of prime importance to have clear definitions of the different validation criteria used to assess this validity. It is also necessary to have Methodologies in accordance with these definitions and consequently to use statistical Methods which are relevant with these definitions, the objective of the validation and the objective of the Analytical Method. The main purpose of this paper is to outline the inconsistencies between some definitions of the criteria and the experimental procedures proposed to evaluate those criteria in recent documents dedicated to the validation of Analytical Methods in the pharmaceutical field, together with the risks and problems when trying to cope with contradictory, and sometimes scientifically irrelevant, requirements and definitions.

  • analysis of recent pharmaceutical regulatory documents on Analytical Method validation
    Journal of Chromatography A, 2007
    Co-Authors: Eric Rozet, Cedric Hubert, Bruno Boulanger, Attilio Ceccato, Eric Ziemons, Radu Oprean, Serge Rudaz, Philippe Hubert
    Abstract:

    All analysts face the same situations as Method validation is the process of proving that an Analytical Method is acceptable for its intended purpose. In order to resolve this problem, the analyst refers to regulatory or guidance documents, and therefore the validity of the Analytical Methods is dependent on the guidance, terminology and Methodology, proposed in these documents. It is therefore of prime importance to have clear definitions of the different validation criteria used to assess this validity. It is also necessary to have Methodologies in accordance with these definitions and consequently to use statistical Methods which are relevant with these definitions, the objective of the validation and the objective of the Analytical Method. The main purpose of this paper is to outline the inconsistencies between some definitions of the criteria and the experimental procedures proposed to evaluate those criteria in recent documents dedicated to the validation of Analytical Methods in the pharmaceutical field, together with the risks and problems when trying to cope with contradictory, and sometimes scientifically irrelevant, requirements and definitions. (c) 2007 Elsevier B.V. All rights reserved.

  • using total error as decision criterion in Analytical Method transfer
    Chemometrics and Intelligent Laboratory Systems, 2007
    Co-Authors: Walthere Dewe, Patrice Chiap, Eric Rozet, Bruno Boulanger, Bernadette Govaerts, Philippe Hubert
    Abstract:

    An Analytical transfer is a complete process that consists in transferring a validated Analytical Method from a sending laboratory (called sender) to a receiving laboratory (called receiver) after having experimentally demonstrated that it also masters the Method. The decision to transfer an Analytical Method is usually taken based on the combination of two criteria: one about systematic error and one about random errors. These usual criteria, their combination and their limitations are described in this paper. As it is for Method validation, total error-based approaches should be also considered in Method transfer. Two approaches are proposed in order to have a total error-based criterion and to take into account the precision of the true value estimate. In the first approach, a beta-expectation tolerance interval similar to the one used in Method validation is calculated and then compared to acceptance limits around the estimate of the true value. The second approach, found as slightly more powerful than the first one, consists in estimating the probability to have a result outside these acceptance limits. (c) 2006 Elsevier B.V. All rights reserved.

Javier M Montserrat - One of the best experts on this subject based on the ideXlab platform.

  • Analytical Method for assessing potential dermal exposure to captan using whole body dosimetry in small vegetable production units in argentina
    Pest Management Science, 2006
    Co-Authors: Enrique A Hughes, Andrea P Flores, Anita Zalts, Javier Ojeda, Richard Glass, Javier M Montserrat
    Abstract:

    An Analytical Method has been developed that can be used to determine the potential dermal exposure (PDE) of workers to the pesticide captan in small-scale horticultural production units. The Methodology is based on the whole body dosimetry technique, using a cotton coverall and cotton gloves as sampling media, with protective clothing worn beneath the cotton media to protect the operator. The quantitative determination of captan was done by gas chromatography-electron capture detector (GC-ECD), with the Analytical Method validated by measuring limits of detection and quantification, linear ranges, sample recovery and precision. Special emphasis is placed on factors that affected the stability of captan during chromatographic determination. The data generated for potential dermal exposure are presented separately for mixing/loading and application activities. These data are compared with values obtained with visible tracers using a similar field technique. Margin of safety (MOS) values are also calculated for the agricultural procedures studied. Copyright © 2006 Society of Chemical Industry

  • Analytical Method for assessing potential dermal exposure to captan using whole body dosimetry in small vegetable production units in argentina
    Pest Management Science, 2006
    Co-Authors: Enrique A Hughes, Andrea P Flores, Anita Zalts, Javier Ojeda, Richard Glass, Javier M Montserrat
    Abstract:

    An Analytical Method has been developed that can be used to determine the potential dermal exposure (PDE) of workers to the pesticide captan in small-scale horticultural production units. The Methodology is based on the whole body dosimetry technique, using a cotton coverall and cotton gloves as sampling media, with protective clothing worn beneath the cotton media to protect the operator. The quantitative determination of captan was done by gas chromatography-electron capture detector (GC-ECD), with the Analytical Method validated by measuring limits of detection and quantification, linear ranges, sample recovery and precision. Special emphasis is placed on factors that affected the stability of captan during chromatographic determination. The data generated for potential dermal exposure are presented separately for mixing/loading and application activities. These data are compared with values obtained with visible tracers using a similar field technique. Margin of safety (MOS) values are also calculated for the agricultural procedures studied.