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Why you never really validate your analytical method unless you use the total error approach (part I: concept)
Consistent and efficient use of any analytical procedure requires the knowledge of its reliability prior to its use. It is therefore necessary for each laboratory to validate their analytical methods. Validation is not only required by regulatory authorities [ICH, FDA, GxP] or in order to access accreditation [ISO 17025] but is also the essential step prior to the routine use of the method. The role of analytical method validation is to provide confidence in laboratory generated results that will later be used to make critical decisions.
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ReadNew SAS solutions for Population PK Model
Population pharmacokinetic (PK) models describe the drug concentration-time course in body fluids resulting from administration of a certain drug dose. Compartment models are typically used to conceptualize the mechanisms that take place in the interaction between an organism and a drug product.
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ReadBayesian Power, Assurance and Probability of Success: Reproducibility Issues
In this current document, we will try to analyze the effects that a misunderstanding of these concepts may lead to and more specifically the effects on reproducibility.
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ReadBayesian Power, Assurance and Probability of success: A quick who’s who
Bayesian power and Assurance allows accounting for the uncertainty on the parameters. These metrics give estimates closer to a probability of success that the trial will indeed be a success. Uncertainty must be accounted for in order to ensure that the appropriate sample size is selected in order to maximize the success of the clinical trial. Read the full article here
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ReadProposal for a Single Arm Clinical Study in Rare Disease using Bayesian Statistics
This short article aims to briefly introduce a methodology to address the challenge of rare clinical trials relying on Bayesian statistical methods, and the use of natural history data to determine the control group and inform the analytical model. You can read the full article here
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ReadNon-clinical safety evaluation of vaccines accelerating clinical development
International Pharmaceutical Industry: Sebastian Joseph discusses regulatory expectations for the non-clinical development of vaccines
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ReadNon-clinical safety evaluation of vaccines accelerating clinical development
Chemistry Today: Sebastian Joseph discusses regulatory expectations for the non-clinical development of vaccines
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ReadSupporting M&As in the pharmaceutical/biopharmaceutical industry
Manufacturing Chemist: At PharmaLex, we believe we have a unique understanding of the cultural challenges experienced during M&As. Having merged ourselves in 2017 into PharmaLex, we have insight in how to overcome the challenges of maintaining agility while benefiting from working in a bigger corporate environment, having economies of scale with an increased resource pool.
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ReadNon-clinical safety evaluation of vaccines part II
Manufacturing Chemist: Sebastian Joseph discusses regulatory expectations for the non-clinical development of vaccines
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ReadNon-clinical safety evaluation of vaccines part I
Manufacturing Chemist: Sebastian Joseph discusses regulatory expectations for the non-clinical development of vaccines
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ReadCan a robust QMS help you achieve customer satisfaction?
PharmaLex.pert Limaris Alvarado discusses the part quality management systems (QMS) play in ensuring companies continually enhance customers’ experience and satisfaction?
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ReadProduct Launch
PharmaLex.pert Limaris Alvarado discusses the complexities of product launch and the importance of effective planning, efficient manufacturing process, technical capability, regulatory strategy, and committed launch date strategy.
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ReadLearning Lessons from Nitrosamine Impurities
PharmaLex.pert Diego Martinez discusses why industry must never become complacent about the safety of drug products and should seek to continually perform surveillance even if the drug is well-established.
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ReadDrug Development Decisions
Zeb Younes & Zaklina Buljovcic will give you insightful information about new approaches to Drug Development. This article is taken from the European Biopharmaceutical Review October 2019, pages 58-64. © Samedan Ltd.
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ReadEMA simplifies the process for internal transfer of MAs
PharmaLex Vice President Regulatory and Scientific Policy, Jonathan Trethowan discusses how the EMA’s simplified process for internal transfer of marketing authorizations may help some Brexit Impacted MAHs.
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ReadAI in drug development|Pharmacovigilance
PharmaLex CEO, Tilo Netzer looks at the opportunities for AI in drug development, examining the use cases in relation to pharmacovigilance
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ReadMoving From Artificial Trials To Smarter Regulatory Process
PharmaLex’s Bruno Boulanger discusses the impact big data will have on how the pharmaceutical industry gathers and delivers data in the future. *subscription required*
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