References of "Hubert, Philippe"
     in
Bookmark and Share    
Full Text
See detailDesign Space ou Espace de Conception
Boulanger, B.; Lebrun, Pierre ULg; Rozet, Eric ULg et al

Scientific conference (2011, November 29)

Detailed reference viewed: 28 (7 ULg)
Full Text
See detailModèles statistiques Bayésiens et méthodologies pour calculer le Design Space (OPTIMAL-DS)
Marini Djang'Eing'A, Roland ULg; Lebrun, Pierre ULg; Hubert, Philippe ULg

Report (2011)

La compréhension des procédés technologiques et industriels dans les secteurs (bio)pharmaceutiques, biotechnologiques, agroalimentaires et environnementaux doit permettre de se conformer aux lignes de ... [more ▼]

La compréhension des procédés technologiques et industriels dans les secteurs (bio)pharmaceutiques, biotechnologiques, agroalimentaires et environnementaux doit permettre de se conformer aux lignes de conduites initiées par la FDA ou d'autres organismes de contrôles. Notamment, le document ICH Q8 introduit les notions de "Process Analytical Technology", de "Quality by Design" et de "Design Space", ayant attraits à la qualité des procédés industriels, des procédés d'analyse ainsi qu'à la qualité des produits finis. Cependant, si les lignes de conduites pour ces exigences sont expliquées, aucune méthodologie pour les atteindre n'est donnée. Or, un nombre considérable de nouvelles entités chimiques sont synthétisées par les laboratoires pharmaceutiques, biotechnologiques ou agroalimentaires. Les producteurs de matières premières et/ou d’excipients (secteur chimique) ont également besoin de disposer rapidement de méthodes analytiques de contrôle qui leur permettront de s’assurer de la qualité de leurs produits. On comprend aisément la nécessité pour ces secteurs de disposer rapidement de résultats fiables puisque les activités de recherches mais aussi des investissements, souvent importants, sont orientés ou stoppés sur base de données chiffrées, produits par les méthodes analytiques. La production de résultats fiables et la démonstration de cette fiabilité sont donc économiquement fondamentales. Ce projet vise la mise au point de stratégies et de modèles génériques de développement automatisé de nouvelles méthodes analytiques séparatives, en se basant sur la modélisation des temps de rétention, la planification expérimentale, et le concept de Design Space. L’objectif connexe est d’appliquer cette méthodologie à l’optimisation de n’importe quel procédé. Le fait de pouvoir disposer d’une méthodologie de mise au point automatique de méthodes analytiques ou de tous procédés analytiques aura un impact significatif. Cette nouvelle technologie permettra de réduire de façon drastique le temps d’optimisation des méthodes et procédés, permettant une production plus efficiente de produits (pharmaceutique, cosmétique, agro-alimentaire ou biotechnologique) répondant aux spécifications du client. [less ▲]

Detailed reference viewed: 16 (1 ULg)
Full Text
See detailRapport d'activités scientifiques du Projet Interuniversitaire Cible
Marini Djang'Eing'A, Roland ULg; Hubert, Philippe ULg

Report (2011)

-Objectif global : L’objectif général est de contribuer à l’amélioration de la santé publique en République Démocratique du Congo (RDC). Ce projet vise à apporter une meilleure protection de la santé des ... [more ▼]

-Objectif global : L’objectif général est de contribuer à l’amélioration de la santé publique en République Démocratique du Congo (RDC). Ce projet vise à apporter une meilleure protection de la santé des malades grâce à la disponibilité de médicaments de meilleures qualités. -Objectif spécifique : L’objectif spécifique poursuivit par ce projet est le renforcement de la prise de conscience par les parties prenantes de l'intérêt des analyses scientifiques fondées sur la vérification de la qualité des médicaments modernes en vue d’améliorer leur qualité. Tout en considérant la même problématique rencontrée avec les médicaments modernes, ce projet s’intéresse également aux médicaments traditionnels améliorés (MTA) à base des plantes médicinales en vue de leur standardisation. Le groupe de médicaments visés comprend les médicaments antiparasitaires notamment les médicaments contre la Malaria, les Diarrhées, la Dysenterie amibienne. Un autre sous objectif poursuivit dans ce projet est le renforcement des capacités du personnel académique et scientifique de l’Université de Kinshasa ainsi que du Ministère de la Santé Publique en RDC. [less ▲]

Detailed reference viewed: 12 (2 ULg)
Full Text
Peer Reviewed
See detailNew Methodology for the Development of Chromatographic Methods
Rozet, Eric ULg; Debrus, Benjamin ULg; Lebrun, Pierre ULg et al

Conference (2011, September 08)

As defined by ICH [1] and FDA, Quality by Design (QbD) stands for “a systematic approach to development that begins with predefined objectives and emphasizes product and process understanding and process ... [more ▼]

As defined by ICH [1] and FDA, Quality by Design (QbD) stands for “a systematic approach to development that begins with predefined objectives and emphasizes product and process understanding and process control, based on sound science and quality risk management”. A risk–based QbD–compliant approach is proposed for the robust development of analytical methods. This methodology based on Design of Experiments (DoE) to study the experimental domain models the retention times at the beginning, the apex and the end of each peak corresponding to the compounds of a mixture and uses the separation criterion (S) rather than the resolution (RS) as a Critical Quality Attribute. Stepwise multiple linear regressions are used to create the models. The estimated error is propagated from the modelled responses to the separation criterion (S) using Monte Carlo simulations in order to estimate the predictive distribution of the separation criterion (S) over the whole experimental domain. This allows finding ranges of operating conditions that will guarantee a satisfactory quality of the method in its future use. These ranges define the Design Space (DS) of the method. In chromatographic terms, the chromatograms processed at operating conditions within the DS will assuredly show high quality, with well separated peaks and short run time, for instance. This Design Space can thus be defined as the subspace, necessarily encompassed in the experimental domain (i.e. the knowledge space), within which the probability for the criterion to be higher than an advisedly selected threshold is higher than a minimum quality level. Precisely, the DS is defined as “the multidimensional combination and interaction of input variables (e.g., material attributes) and process parameters that have been demonstrated to provide assurance of quality” [1]. Therefore, this DS defines a region of operating conditions that provide prediction of assurance of quality rather than only quality as obtained with traditional mean response surface optimisation strategies. For instance, in the liquid chromatography there is a great difference in e.g. predicting a resolution (RS) higher than 1.5 vs. predicting that the probability for RS to be higher than 1.5 (i.e. P(RS> 1.5)) is high. The presentation of this global methodology will be illustrated for the robust optimisation and DS definition of several liquid chromatographic methods dedicated to the separation of different mixtures: pharmaceutical formulations, API and impurities/degradation products, plant extracts, separation of enantiomers, … References [1] International Conference on Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use, Topic Q8(R2): Pharmaceutical development, Geneva, 2009. Acknowledgements A research grant from the Belgium National Fund for Scientific Research (F.R.S-FNRS) to E. Rozet is gratefully acknowledged. [less ▲]

Detailed reference viewed: 44 (7 ULg)
Full Text
Peer Reviewed
See detailNEW TRENDS IN VALIDATION OF ANALYTICAL METHODS
Rozet, Eric ULg; Hubert, Philippe ULg

Conference (2011, September 08)

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 ▲]

Detailed reference viewed: 65 (5 ULg)
Full Text
See detailContribution au développement des capacités d’enseignement et de formation pour l’amélioration de la qualité du médicament (acronyme : DEV-AQM)
Marini Djang'Eing'A, Roland ULg; Hubert, Philippe ULg

Report (2011)

Project title: Contribution to the development of teaching capacity and training for the improvement of quality of the medicines. Contextualisation: The quality of medicines is a major problem of public ... [more ▼]

Project title: Contribution to the development of teaching capacity and training for the improvement of quality of the medicines. Contextualisation: The quality of medicines is a major problem of public health in the development countries. Since 1990, this situation has deteriorated becoming worried mainly in the Central African region due to the degradation of social, economic and politic life, consequence of a long period of conflict and war. The resurgence of non-controlled drugs, the sale of illicit, deteriorated and even falsified drugs are real examples in the current practices, that is making difficult and even practically impossible an access to a safe, reliable and efficient medical treatment. It is known that even if a diagnosis is correctly made and a medical treatment is correctly prescribed, this treatment is doomed to failure if the medicine is not of a good quality. Democratic Republic of Congo (DRC) and Rwanda are among the countries that are facing such situations. Description of project purpose: The principal objective of this project is to contribute to the improvement of the quality of medicines and thus, of the public health in DRC and in Rwanda. More precisely, the project aims to strengthen the local capacity in order to respond to the need in the quality of medicines and to develop a platform of people in the pharmaceutical sector in the field of quality assurance and control. According to this main objective, the project aims in one hand to train people working in the pharmaceutical sector including the academic, the legal and the industrial, and in another hand to develop the tools to contribute to the improvement of the quality of medicines. Training and qualification of people, improvement of the teaching and making available the control documentation on quality are the sub-objectives pursued in the framework of this project. Chapter 2 : Six main activities are undergone in this project: The first activity is the seminar that is organised in order to promote the project and to initiate the importance of knowledge of the quality of medicine by awareness of the different authorities from government, from the churches and from the health sectors. The seminar is the preliminary step of this project that is done to select the different candidates. The second activity concerns the theoretical training, focused on the basis of the quality of drugs, the drug manufacturing and drug control / analysis taking into account the activity sector of each candidate. This activity is important since most of the candidates have been graduated a long time ago while working for a long time. This activity as well as the seminar is held in the beneficiary countries for one month. The trainers are among the Professors and Researchers from the “University of Liège”, the “University Libre de Bruxelles” and the “University Catholique de Louvain”, in Belgium. They are selected on basis of their expertise. The topics considered are the Quality Assurance, the Regulatory, the Statistical applied in the pharmaceutical industry, The Manufacturing and The Quality control of medicines, the Management in the Pharmaceutical sector. The theoretical training by e-learning using internet occurs in the third place. It is done as a complement to the second activity since it allows the candidate to have access to different and more documents available through the web site platform created for this purpose. This mode of teaching allows also the candidates to interact with other trainers concerning a particular subject of their working sector. The fourth activity is the practices that are done in Belgium in the different facilities of the laboratories associated to this project. This allows the different candidates to materialize the knowledge acquired during the theoretical teaching while considering their working sector, and to familiarize with the procedures dealing with their sector. The fifth activity is related to a specific training for auditor or evaluator. Indeed, this training is a specific requirement namely the creation of Federal Agency of Drug in DRC. The need is to improve the capacity of such organism to carry out efficiently the audits and evaluations of drug registration files before their commercialization. Finally, the sixth activity is the reintegration of the candidates within their professional environment. Considering the importance of this aspect, an accompanying is necessary to ensure that the acquired knowledge is valued in the professional environment. Chapter 3 : The expected impact At the end of this project, we expect that the different Authorities are aware with regard to the quality of drugs, the activities in the pharmaceutical sectors namely, the legal and industrial are improved since the actors are trained, qualified and gained competence. We expect also the improvement of teaching capacity in Pharmacy Schools taking into account the need of the pharmaceutical market, with the possibility of starting the post-university teaching programs. Finally, we expect the efficiency of activities in the pharmaceutical sector for the benefit of the DRC and Rwanda populations. Contact person : Philippe Hubert (ph.hubert@ulg.ac.be) / Roland Marini Djang’eing’a (rmarini@ulg.ac.be) Address : Service de Chimie Analytique, Département de Pharmacie, Bât. B36, Avenue de l'Hôpital, 1, 4000 Liège 1, Belgium. Tel. + 00 32 4 366 43 15 [less ▲]

Detailed reference viewed: 34 (5 ULg)
Full Text
Peer Reviewed
See detailHigh Throughput determination of Levonorgestrel in human plasma using a Sensitive LC-MS/MS method
Hubert, Cédric ULg; Streel, Bruno; Sibenaler, Renilde et al

Poster (2011, June 19)

Detailed reference viewed: 199 (19 ULg)
Full Text
See detailProtocole d'essai LC/MS - P001 - V01
Hubert, Cédric ULg; Ziemons, Eric ULg; Hubert, Philippe ULg

Report (2011)

Detailed reference viewed: 10 (1 ULg)
See detailFrom the Clinics to the Bench and back to the Clinics: design of a medical treatment for Cervical Intraepithelial Neoplasia (CIN)
Jost, Maud; Frankenne, Francis; Maillard, Catherine ULg et al

Conference (2011, May 20)

Detailed reference viewed: 25 (12 ULg)