ABSTRACT
The 2013 7th Workshop on Recent Issues in Bioanalysis was held in Long Beach, California, USA, where close to 500 professionals from pharmaceutical and biopharmaceutical companies, CROs and regulatory agencies convened to discuss current topics of interest in bioanalysis. These 'hot' topics, which covered both small and large molecules, were the starting point for fruitful exchanges of knowledge, and sharing of ideas among speakers, panelists and attendees. The discussions led to specific recommendations pertinent to bioanalytical science. Such as the previous editions, this 2013 White Paper addresses important bioanalytical issues and provides practical answers to the topics presented, discussed and agreed upon by the global bioanalytical community attending the 7th Workshop on Recent Issues in Bioanalysis.
Subject(s)
Drug Discovery/methods , Animals , Biochemistry/methods , Biochemistry/standards , Biomarkers, Pharmacological/analysis , California , Chemistry Techniques, Analytical/methods , Chemistry Techniques, Analytical/standards , Drug Approval/methods , Drug Discovery/standards , Humans , Pharmacokinetics , Validation Studies as TopicABSTRACT
Over 400 professionals representing pharmaceutical companies, CROs, and multiple regulatory agencies participated in the 6th Workshop on Recent Issues in Bioanalysis (WRIB). Like the previous sessions, this event was in the format of a practical, focused, highly interactive and informative workshop aiming for high-quality, improved regulatory compliance and scientific excellence. Numerous 'hot' topics in bioanalysis of both small and large molecules were shared and discussed, leading to consensus and recommendations among panelists and attendees representing the bioanalytical community. The major outcome of this year's workshop was the noticeable alignment of multiple bioanalytical guidance/guidelines from different regulatory agencies. This represents a concrete step forward in the global harmonization of bioanalytical activities. The present 2012 White Paper acts as a practical and useful reference document that provides key information and solutions on several topics and issues in the constantly evolving world of bioanalysis.
Subject(s)
Chromatography, High Pressure Liquid/methods , Guidelines as Topic , Immunoassay/methods , Mass Spectrometry/methods , Pharmaceutical Preparations/analysis , Recombinant Proteins/analysis , Calibration , Chromatography, High Pressure Liquid/standards , Dried Blood Spot Testing/methods , Drug Industry , Government Regulation , Humans , Immunoassay/standards , Mass Spectrometry/standards , Reproducibility of Results , Sensitivity and Specificity , Validation Studies as TopicABSTRACT
The 5th Workshop on Recent Issues in Bioanalysis (WRIB) was organized by the Calibration and Validation Group as a 2-day full immersion workshop for pharmaceutical companies, CROs and regulatory agencies to discuss, review, share perspectives, provide potential solutions and agree upon a consistent approach to recent issues in the bioanalysis of both small and large molecules. High quality, better compliance to regulations and scientific excellence are the foundation of this workshop. As in the previous editions of this significant event, recommendations were made and a consensus was reached among panelists and attendees, including industry leaders and regulatory experts representing the global bioanalytical community, on many 'hot' topics in bioanalysis. This 2011 White Paper is based on the conclusions from this workshop, and aims to provide a practical reference guide on those topics.
Subject(s)
Pharmaceutical Preparations/analysis , Calibration , Chromatography, High Pressure Liquid/methods , Chromatography, High Pressure Liquid/standards , Dried Blood Spot Testing/methods , Dried Blood Spot Testing/standards , Drug Industry , Government Regulation , Guidelines as Topic , Humans , Mass Spectrometry/instrumentation , Mass Spectrometry/methods , Mass Spectrometry/standards , Technology Transfer , Tissue Array Analysis/methods , Tissue Array Analysis/standards , Validation Studies as TopicABSTRACT
Regulatory approaches for evaluating therapeutic equivalence of multisource (or generic) drug products vary among different countries and/or regions. Harmonization of these approaches may decrease the number of in vivo bioequivalence studies and avoid unnecessary drug exposure to humans. Global harmonization for regulatory requirements may be promoted by a better understanding of factors underlying product performance and expectations from different regulatory authorities. This workshop provided an opportunity for pharmaceutical scientists from academia, industry and regulatory agencies to have open discussions on current regulatory issues and industry practices, facilitating harmonization of regulatory approaches for establishing therapeutic equivalence and interchangeability of multisource drug products.
Subject(s)
Drug Approval/legislation & jurisprudence , Drugs, Generic/pharmacokinetics , Therapeutic Equivalency , Canada , Drug Evaluation, Preclinical/methods , Europe , Humans , Internationality , United States , World Health OrganizationABSTRACT
Regulatory approaches for evaluating therapeutic equivalence of multisource (or generic) drug products vary among different countries and/or regions. Harmonization of these approaches may decrease the number of in vivo bioequivalence studies and avoid unnecessary drug exposure to humans. Global harmonization for regulatory requirements may be promoted by a better understanding of factors underlying product performance and expectations from different regulatory authorities. This workshop provided an opportunity for pharmaceutical scientists from academia, industry and regulatory agencies to have open discussions on current regulatory issues and industry practices, facilitating harmonization of regulatory approaches for establishing therapeutic equivalence and interchangeability of multisource drug products.
Subject(s)
Therapeutic Equivalency , Drug Approval/legislation & jurisprudence , Humans , Pharmacokinetics , United States , United States Food and Drug Administration , World Health OrganizationABSTRACT
The 4th Calibration and Validation Group Workshop on Recent Issues in Regulated Bioanalysis, a 2-day full immersion workshop, was organized by the Calibration and Validation Group. Contract research organizations, pharmaceutical companies and regulatory agencies came together to discuss several 'hot' topics concerning bioanalytical issues and regulatory challenges and to reach a consensus among panelists and attendees on many points regarding method validation of small and large molecules.
Subject(s)
Biopharmaceutics/methods , Chemistry Techniques, Analytical/methods , International Cooperation , Pharmaceutical Preparations/analysis , Biopharmaceutics/standards , Calibration , Chemistry Techniques, Analytical/standards , Humans , Pharmaceutical Preparations/standards , Quality Control , QuebecABSTRACT
The 3rd Calibration and Validation Group Workshop on Recent Issues in Regulated Bioanalysis was organized by the Calibration and Validation Group as a 1.5-day full immersion workshop for contract research organizations, pharmaceutical companies and regulatory agencies to discuss several 'hot' topics concerning bioanalytical issues and regulatory challenges. A consensus was reached among panelists and attendees on many points regarding method validation of small molecules.
Subject(s)
Chemistry Techniques, Analytical/methods , Pharmaceutical Preparations/analysis , Chemistry Techniques, Analytical/standards , Humans , Validation Studies as TopicABSTRACT
This event was organized by the Calibration and Validation Group (a scientific nonprofit organization based in Toronto, Canada) as a 1.5-day workshop for contract research organizations and pharmaceutical companies involved in providing bioanalytical data for bioavailability, bioequivalence, pharmacokinetic and comparability studies.