The Experts below are selected from a list of 339630 Experts worldwide ranked by ideXlab platform
Edward D Bashaw - One of the best experts on this subject based on the ideXlab platform.
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Bioanalytical Method Validation: Concepts, Expectations and Challenges in Small Molecule and Macromolecule—A Report of PITTCON 2013 Symposium
The AAPS Journal, 2014Co-Authors: Edward D Bashaw, Binodh Desilva, Mark J. Rose, Yow-ming C. Wang, Chinmay ShuklaAbstract:The concepts, importance, and implications of bioanalytical Method Validation has been discussed and debated for a long time. The recent high profile issues related to bioanalytical Method Validation at both Cetero Houston and former MDS Canada has brought this topic back in the limelight. Hence, a symposium on bioanalytical Method Validation with the aim of revisiting the building blocks as well as discussing the challenges and implications on the bioanalysis of both small molecules and macromolecules was featured at the PITTCON 2013 Conference and Expo. This symposium was cosponsored by the American Chemical Society (ACS)—Division of Analytical Chemistry and Analysis and Pharmaceutical Quality (APQ) Section of the American Association of Pharmaceutical Scientists (AAPS) and featured leading speakers from the Food & Drug Administration (FDA), academia, and industry. In this symposium, the speakers shared several unique examples, and this session also provided a platform to discuss the need for continuous vigilance of the bioanalytical Methods during drug discovery and development. The purpose of this article is to provide a concise report on the materials that were presented.
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Bioanalytical Method Validation: concepts, expectations and challenges in small molecule and macromolecule--a report of PITTCON 2013 symposium.
Aaps Journal, 2014Co-Authors: Edward D Bashaw, Binodh Desilva, Mark J. Rose, Yow-ming C. Wang, Chinmay G. ShuklaAbstract:The concepts, importance, and implications of bioanalytical Method Validation has been discussed and debated for a long time. The recent high profile issues related to bioanalytical Method Validation at both Cetero Houston and former MDS Canada has brought this topic back in the limelight. Hence, a symposium on bioanalytical Method Validation with the aim of revisiting the building blocks as well as discussing the challenges and implications on the bioanalysis of both small molecules and macromolecules was featured at the PITTCON 2013 Conference and Expo. This symposium was cosponsored by the American Chemical Society (ACS)—Division of Analytical Chemistry and Analysis and Pharmaceutical Quality (APQ) Section of the American Association of Pharmaceutical Scientists (AAPS) and featured leading speakers from the Food & Drug Administration (FDA), academia, and industry. In this symposium, the speakers shared several unique examples, and this session also provided a platform to discuss the need for continuous vigilance of the bioanalytical Methods during drug discovery and development. The purpose of this article is to provide a concise report on the materials that were presented.
Chinmay G. Shukla - One of the best experts on this subject based on the ideXlab platform.
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Bioanalytical Method Validation: concepts, expectations and challenges in small molecule and macromolecule--a report of PITTCON 2013 symposium.
Aaps Journal, 2014Co-Authors: Edward D Bashaw, Binodh Desilva, Mark J. Rose, Yow-ming C. Wang, Chinmay G. ShuklaAbstract:The concepts, importance, and implications of bioanalytical Method Validation has been discussed and debated for a long time. The recent high profile issues related to bioanalytical Method Validation at both Cetero Houston and former MDS Canada has brought this topic back in the limelight. Hence, a symposium on bioanalytical Method Validation with the aim of revisiting the building blocks as well as discussing the challenges and implications on the bioanalysis of both small molecules and macromolecules was featured at the PITTCON 2013 Conference and Expo. This symposium was cosponsored by the American Chemical Society (ACS)—Division of Analytical Chemistry and Analysis and Pharmaceutical Quality (APQ) Section of the American Association of Pharmaceutical Scientists (AAPS) and featured leading speakers from the Food & Drug Administration (FDA), academia, and industry. In this symposium, the speakers shared several unique examples, and this session also provided a platform to discuss the need for continuous vigilance of the bioanalytical Methods during drug discovery and development. The purpose of this article is to provide a concise report on the materials that were presented.
Chinmay Shukla - One of the best experts on this subject based on the ideXlab platform.
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Bioanalytical Method Validation: Concepts, Expectations and Challenges in Small Molecule and Macromolecule—A Report of PITTCON 2013 Symposium
The AAPS Journal, 2014Co-Authors: Edward D Bashaw, Binodh Desilva, Mark J. Rose, Yow-ming C. Wang, Chinmay ShuklaAbstract:The concepts, importance, and implications of bioanalytical Method Validation has been discussed and debated for a long time. The recent high profile issues related to bioanalytical Method Validation at both Cetero Houston and former MDS Canada has brought this topic back in the limelight. Hence, a symposium on bioanalytical Method Validation with the aim of revisiting the building blocks as well as discussing the challenges and implications on the bioanalysis of both small molecules and macromolecules was featured at the PITTCON 2013 Conference and Expo. This symposium was cosponsored by the American Chemical Society (ACS)—Division of Analytical Chemistry and Analysis and Pharmaceutical Quality (APQ) Section of the American Association of Pharmaceutical Scientists (AAPS) and featured leading speakers from the Food & Drug Administration (FDA), academia, and industry. In this symposium, the speakers shared several unique examples, and this session also provided a platform to discuss the need for continuous vigilance of the bioanalytical Methods during drug discovery and development. The purpose of this article is to provide a concise report on the materials that were presented.
Eric Rozet - One of the best experts on this subject based on the ideXlab platform.
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Quality by Design Compliant Analytical Method Validation
Analytical chemistry, 2011Co-Authors: Eric Rozet, Eric Ziemons, Roland Djang’eing’a Marini, B. Boulanger, Ph. HubertAbstract: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.
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critical analysis of several analytical Method Validation strategies in the framework of the fit for purpose concept
Journal of Chromatography A, 2010Co-Authors: A Bouabidi, Eric Rozet, Eric Ziemons, Marianne Fillet, E Chapuzet, B Mertens, Regis Klinkenberg, Attilio Ceccato, Mohammed Talbi, Bruno StreelAbstract:Analytical Method Validation is a mandatory step at the end of the development in all analytical laboratories. It is a highly regulated step of the life cycle of a quantitative analytical Method. However, even if some documents have been published there is a lack of clear guidance for the Methodology to follow to adequately decide when a Method can be considered as valid. This situation has led to the availability of several Methodological approaches and it is therefore the responsibility of the analyst to choose the best one. The classical decision processes encountered during Method Validation evaluation are compared, namely the descriptive, difference and equivalence approaches. Furthermore a Validation approach using accuracy profile computed by means of β-expectation tolerance interval and total measurement error is also available. In the present paper all of these different Validation approaches were applied to the Validation of two analytical Methods. The evaluation of the producer and consumer risks by Monte Carlo simulations were also made in order to compare the appropriateness of these various approaches. The classical Methodologies give rise to inadequate and contradictory conclusions which do not allow them to answer adequately the objective of Method Validation, i.e. to give enough guarantees that each of the future results that will be generated by the Method during routine use will be close enough to the true value. It is found that the Validation Methodology which gives the most guarantees with regards to the reliability or adequacy of the decision to consider a Method as valid is the one based on the use of the accuracy profile.
Yow-ming C. Wang - One of the best experts on this subject based on the ideXlab platform.
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Bioanalytical Method Validation: Concepts, Expectations and Challenges in Small Molecule and Macromolecule—A Report of PITTCON 2013 Symposium
The AAPS Journal, 2014Co-Authors: Edward D Bashaw, Binodh Desilva, Mark J. Rose, Yow-ming C. Wang, Chinmay ShuklaAbstract:The concepts, importance, and implications of bioanalytical Method Validation has been discussed and debated for a long time. The recent high profile issues related to bioanalytical Method Validation at both Cetero Houston and former MDS Canada has brought this topic back in the limelight. Hence, a symposium on bioanalytical Method Validation with the aim of revisiting the building blocks as well as discussing the challenges and implications on the bioanalysis of both small molecules and macromolecules was featured at the PITTCON 2013 Conference and Expo. This symposium was cosponsored by the American Chemical Society (ACS)—Division of Analytical Chemistry and Analysis and Pharmaceutical Quality (APQ) Section of the American Association of Pharmaceutical Scientists (AAPS) and featured leading speakers from the Food & Drug Administration (FDA), academia, and industry. In this symposium, the speakers shared several unique examples, and this session also provided a platform to discuss the need for continuous vigilance of the bioanalytical Methods during drug discovery and development. The purpose of this article is to provide a concise report on the materials that were presented.
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Bioanalytical Method Validation: concepts, expectations and challenges in small molecule and macromolecule--a report of PITTCON 2013 symposium.
Aaps Journal, 2014Co-Authors: Edward D Bashaw, Binodh Desilva, Mark J. Rose, Yow-ming C. Wang, Chinmay G. ShuklaAbstract:The concepts, importance, and implications of bioanalytical Method Validation has been discussed and debated for a long time. The recent high profile issues related to bioanalytical Method Validation at both Cetero Houston and former MDS Canada has brought this topic back in the limelight. Hence, a symposium on bioanalytical Method Validation with the aim of revisiting the building blocks as well as discussing the challenges and implications on the bioanalysis of both small molecules and macromolecules was featured at the PITTCON 2013 Conference and Expo. This symposium was cosponsored by the American Chemical Society (ACS)—Division of Analytical Chemistry and Analysis and Pharmaceutical Quality (APQ) Section of the American Association of Pharmaceutical Scientists (AAPS) and featured leading speakers from the Food & Drug Administration (FDA), academia, and industry. In this symposium, the speakers shared several unique examples, and this session also provided a platform to discuss the need for continuous vigilance of the bioanalytical Methods during drug discovery and development. The purpose of this article is to provide a concise report on the materials that were presented.
