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See detailUsefulness of capability indices in the framework of analytical methods validation
Bouabidi, Abderrahim ULg; Ziemons, Eric ULg; Marini Djang'Eing'A, Roland ULg et al

in Analytica Chimica Acta (2012), 714

Analytical methods capability evaluation can be a useful methodology to assess the fitness of purpose of these methods for their future routine application. However, care on how to compute the capability ... [more ▼]

Analytical methods capability evaluation can be a useful methodology to assess the fitness of purpose of these methods for their future routine application. However, care on how to compute the capability indices has to be made. Indeed, the commonly used formulas to compute capability indices such as Cpk, will highly overestimate the true capability of the methods. Especially during methods validation or transfer, there are only few experiments performed and, using in these situations the commonly applied capability indices to declare a method as valid or as transferable to a receiving laboratory will conduct to inadequate decisions. In this work, an improved capability index, namely Cpk-tol and the corresponding estimator of proportion of non conforming results ( ) has been proposed. Through Monte-Carlo simulations, they have been shown to greatly increase the estimation of analytical methods capability in particular in low sample size situations as encountered during methods validation or transfer. Additionally, the usefulness of this capability index has been illustrated through several case studies covering applications commonly encountered in the pharmaceutical industry. Finally a methodology to determine the optimal sample size required to validate analytical methods is also given using the proposed capability metric. [less ▲]

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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 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)

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 ... [more ▼]

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 ▲]

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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 ▲]

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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 ▲]

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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: 35 (5 ULg)
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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 ▲]

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See detailContrôle qualité
Marini Djang'Eing'A, Roland ULg; Ziemons, Eric ULg; Hubert, Philippe ULg

Article for general public (2011)

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See detailLe fléau des faux médicaments
Marini Djang'Eing'A, Roland ULg; Ziemons, Eric ULg; Hubert, Philippe ULg

E-print/Working paper (2011)

The traffic in counterfeit medicines is booming. It misleads, and it kills. A University of Liège team is making Rwandan and Congolese health care workers aware of the problem, whilst informing and ... [more ▼]

The traffic in counterfeit medicines is booming. It misleads, and it kills. A University of Liège team is making Rwandan and Congolese health care workers aware of the problem, whilst informing and training them, so that they may detect and monitor these products, thanks to made to measure appropriate technical systems. [less ▲]

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See detailTotal Error and Uncertainty: Friends or Foes?
Rozet, Eric ULg; Dewe, Walthere; Rudaz, Serge et al

in Trends in Analytical Chemistry (2011), 30(5), 797-806

The guidelines ISO 17025 and ISO 15189 aim at improving the quality assurance scheme of laboratories. Reliable analytical results are of core importance due to the critical decisions that are taken with ... [more ▼]

The guidelines ISO 17025 and ISO 15189 aim at improving the quality assurance scheme of laboratories. Reliable analytical results are of core importance due to the critical decisions that are taken with them. Therefore among other topics, these documents require that analytical methods be validated and that laboratories should be able to provide measurement uncertainty of their measured routine results. To evaluate analytical methods fitness of purpose, total error has been and is more and more applied to assess reliability of results generated by analytical methods. However, the ISO requirement to estimate measurement uncertainty seems in opposition with the total error concept, leading to delays in their implementation by laboratories and increased confusion for the analysts. Thus, this article aims at clarifying the divergences between total error and measurement uncertainty, but also to discuss their main similarities and give some emphasise to their implementations. [less ▲]

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See detailModels to estimate overall analytical measurements uncertainty: assumptions, comparisons and applications
Rozet, Eric ULg; Rudaz, S.; Marini Djang'Eing'A, Roland ULg et al

in Analytica Chimica Acta (2011), 702

Evaluation of analytical results reliability is of core importance as crucial decisions are taken with them. From the various methodologies to evaluate the fitness of purpose of analytical methods ... [more ▼]

Evaluation of analytical results reliability is of core importance as crucial decisions are taken with them. From the various methodologies to evaluate the fitness of purpose of analytical methods, overall measurement uncertainty estimation is more and more applied. Overall measurement uncertainty allows to combine simultaneously the remaining systematic influences to the random sources of uncertainty and allows assessing the reliability of results generated by analytical methods. However there are various interpretations on how to estimate overall measurement uncertainty, and thus various models for estimating it. Each model together with its assumptions has great impacts on the risks to abusively declare that analytical methods are suitable for their intended purpose. This review paper aims at i) summarizing the various models used to estimate overall measurement uncertainty, ii) provide their pros and cons, iii) review the main areas of application and iv) as a conclusion provide some recommendations when evaluating overall measurement uncertainty. [less ▲]

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See detailInnovative high-performance liquid chromatography method development for the screening of 19 antimalarial drugs based on a generic approach, using design of experiments, independent component analysis and design space
Debrus, Benjamin ULg; Lebrun, Pierre ULg; Mbinze Kindenge, Jérémie et al

in Journal of Chromatography. A (2011), 1218

An innovative methodology based on design of experiments (DoE), independent component analysis (ICA) and design space (DS) was developed in previous works and was tested out with a mixture of 19 ... [more ▼]

An innovative methodology based on design of experiments (DoE), independent component analysis (ICA) and design space (DS) was developed in previous works and was tested out with a mixture of 19 antimalarial drugs. This global LC method development methodology (i.e. DoE–ICA–DS) was used to optimize the separation of 19 antimalarial drugs to obtain a screening method. DoE–ICA–DS methodology is fully compliant with the current trend of quality by design. DoE was used to define the set of experiments to model the retention times at the beginning, the apex and the end of each peak. Furthermore, ICA was used to numerically separate coeluting peaks and estimate their unbiased retention times. Gradient time, temperature and pH were selected as the factors of a full factorial design. These retention times were modelled by stepwise multiple linear regressions. A recently introduced critical quality attribute, namely the separation criterion (S), was also used to assess the quality of separations rather than using the resolution. Furthermore, the resulting mathematical models were also studied from a chromatographic point of view to understand and investigate the chromatographic behaviour of each compound. Good adequacies were found between the mathematical models and the expected chromatographic behaviours predicted by chromatographic theory. Finally, focusing at quality risk management, the DS was computed as the multidimensional subspace where the probability for the separation criterion to lie in acceptance limits was higher than a defined quality level. The DS was computed propagating the prediction error from the modelled responses to the quality criterion using Monte Carlo simulations. DoE–ICA–DS allowed encountering optimal operating conditions to obtain a robust screening method for the 19 considered antimalarial drugs in the framework of the fight against counterfeit medicines. Moreover and only on the basis of the same data set, a dedicated method for the determination of three antimalarial compounds in a pharmaceutical formulation was optimized to demonstrate both the efficiency and flexibility of the methodology proposed in the present study. [less ▲]

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See detailAdvances in validation, risk and uncertainty assessment of bioanalytical methods
Rozet, Eric ULg; Marini Djang'Eing'A, Roland ULg; Ziemons, Eric ULg et al

in Journal of Pharmaceutical & Biomedical Analysis (2011), 55

Bioanalytical 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 ... [more ▼]

Bioanalytical 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 bioanalytical method validations, there is still the need to clarify the meaning and interpretation of bioanalytical method validation criteria and methodology. 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 bioanalytical method may be unfit for its future purpose will depend on analysts personal interpretation of these guidelines. The objective of this review is thus to discuss and highlight several essential aspects of methods validation, not only restricted to chromatographic ones but also to ligand binding assays owing to their increasing role in biopharmaceutical industries. The points that will be reviewed are the common validation criteria, which are selectivity, standard curve, trueness, precision, accuracy, limits of quantification and range, dilutional integrity and analyte stability. Definitions, methodology, experimental design and decision criteria are reviewed. Two other points closely connected to method validation are also examined: incurred sample reproducibility testing and measurement uncertainty as they are highly linked to bioanalytical results reliability. Their additional implementation is foreseen to strongly reduce the risk of having validated a bioanalytical method unfit for its purpose. [less ▲]

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