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1.
Bioanalysis ; 8(6): 487-95, 2016 Mar.
Article in English | MEDLINE | ID: mdl-26916197

ABSTRACT

The 9th GCCClosed Forum was held just prior to the 2015 Workshop on Recent Issues in Bioanalysis (WRIB) in Miami, FL, USA on 13 April 2015. In attendance were 58 senior-level participants, from eight countries, representing 38 CRO companies offering bioanalytical services. The objective of this meeting was for CRO bioanalytical representatives to meet and discuss scientific and regulatory issues specific to bioanalysis. The issues selected at this year's closed forum include CAPA, biosimilars, preclinical method validation, endogenous biomarkers, whole blood stability, and ELNs. A summary of the industry's best practices and the conclusions from the discussion of these topics is included in this meeting report.


Subject(s)
Biomarkers/analysis , Biosimilar Pharmaceuticals/analysis , Drug Evaluation, Preclinical/methods , Biomarkers/blood , Electronic Health Records , Laboratories , Societies, Medical , Validation Studies as Topic
2.
Bioanalysis ; 6(18): 2385-90, 2014 Sep.
Article in English | MEDLINE | ID: mdl-25384591

ABSTRACT

The topic of incurred sample stability (ISS) has generated considerable discussion within the bioanalytical community in recent years. The subject was an integral part of the seventh annual Workshop on Recent Issues in Bioanalysis (WRIB) held in Long Beach, CA, USA, in April 2013, and at the Global CRO Council for Bioanalysis (GCC) meeting preceding it. Discussion at both events focused on the use of incurred samples for ISS purposes in light of results from a recent GCC survey completed by member companies. This paper reports the consensus resulting from these discussions and serves as a useful reference for depicting ISS issues and concerns, summarizing the GCC survey results and providing helpful recommendations on ISS in the context of bioanalytical method development and application.


Subject(s)
Clinical Chemistry Tests , Data Collection , Reproducibility of Results
4.
Bioanalysis ; 5(23): 2903-18, 2013 Dec.
Article in English | MEDLINE | ID: mdl-24107004

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 Topic
5.
Bioanalysis ; 4(18): 2213-26, 2012 Sep.
Article in English | MEDLINE | ID: mdl-23046264

ABSTRACT

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 Topic
6.
J Pharm Sci ; 101(11): 4075-99, 2012 Nov.
Article in English | MEDLINE | ID: mdl-22911654

ABSTRACT

During the last century, particularly the latter half, spectacular progress has been made in improving the health and longevity of people. The reasons are many, but the development of medicines has played a critical role. This report documents and reflects on the impressive contribution that those working in the pharmaceutical sciences have made to healthcare over the past 50 years. It is divided into six sections (drug discovery; absorption, distribution, metabolism, and excretion; pharmacokinetics and pharmacodynamics; drug formulation; drug regulation; and drug utilization), each describing key contributions that have been made in the progression of medicines, from conception to use. A common thread throughout is the application of translational science to the improvement of drug discovery, development, and therapeutic application. Each section has been coordinated by a leading scientist who was asked, after consulting widely with many colleagues across the globe, to identify "The five most influential ideas/concepts/developments introduced by 'pharmaceutical scientists' (in their field) over the past 50 years?" Although one cannot predict where the important breakthroughs will come in the future to meet the unmet medical needs, the evidence presented in this report should leave no doubt that those engaged in the pharmaceutical sciences will continue to make their contributions heavily felt.


Subject(s)
Chemistry, Pharmaceutical/history , Drug Discovery , History, 20th Century , History, 21st Century , Pharmacokinetics , Pharmacology
7.
Bioanalysis ; 3(18): 2081-96, 2011 Sep.
Article in English | MEDLINE | ID: mdl-21942519

ABSTRACT

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 Topic
9.
Bioanalysis ; 3(9): 993-1000, 2011 May.
Article in English | MEDLINE | ID: mdl-21545347

ABSTRACT

The reanalysis of incurred bioanalytical samples (incurred sample reanalysis) provides additional data that help us to ensure that a 'validated bioanalytical method' is reproducible. While the guidelines for the conduct of incurred sample reanalysis evaluations have been well described, published information pertaining to the occurrence of failures and the manner in which they are resolved has not received the same amount of attention. The purpose of this manuscript is to describe two case studies where incurred sample reanalysis failures were encountered for small molecules, the approaches that were taken to elucidate the root cause of the failures, and the remedial actions that were implemented to prevent such failures from recurring.


Subject(s)
Artifacts , Drug Stability , Pharmaceutical Preparations/blood , Specimen Handling/methods , Biotransformation , Calibration/standards , Chromatography, Liquid , Drug Storage/standards , Guidelines as Topic , Humans , Mass Spectrometry , Quality Control , Reference Standards , Reproducibility of Results , Sensitivity and Specificity , Solid Phase Extraction , Time Factors , Validation Studies as Topic
10.
Bioanalysis ; 2(1): 53-68, 2010 Jan.
Article in English | MEDLINE | ID: mdl-21083120

ABSTRACT

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 Topic
12.
Bioanalysis ; 2(12): 1945-60, 2010 Dec.
Article in English | MEDLINE | ID: mdl-21110739

ABSTRACT

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 , Quebec
13.
AAPS J ; 12(3): 371-7, 2010 Sep.
Article in English | MEDLINE | ID: mdl-20440588

ABSTRACT

Modified release products are complex dosage forms designed to release drug in a controlled manner to achieve desired efficacy and safety. Inappropriate control of drug release from such products may result in reduced efficacy or increased toxicity. This workshop provided an opportunity for pharmaceutical scientists from academia, industry, and regulatory agencies to discuss current industry practices and regulatory expectations for demonstrating pharmaceutical equivalence and bioequivalence of MR products, further facilitating the establishment of regulatory standards for ensuring therapeutic equivalence of these products.


Subject(s)
Therapeutic Equivalency , Pharmaceutical Preparations
14.
Eur J Pharm Sci ; 40(2): 148-53, 2010 May 12.
Article in English | MEDLINE | ID: mdl-20347972

ABSTRACT

Modified-release products are complex dosage forms designed to release drug in a controlled manner to achieve desired efficacy and safety. Inappropriate control of drug release from such products may result in reduced efficacy or increased toxicity. This workshop provided an opportunity for pharmaceutical scientists from academia, industry and regulatory agencies to discuss current regulatory expectations and industry practices for demonstrating pharmaceutical equivalence and bioequivalence of MR products, further facilitating the establishment of regulatory standards for ensuring therapeutic equivalence of these products.


Subject(s)
Delayed-Action Preparations/pharmacology , Delayed-Action Preparations/pharmacokinetics , Drug and Narcotic Control/legislation & jurisprudence , Bupropion/pharmacokinetics , Bupropion/pharmacology , Chemistry, Pharmaceutical , Drug Approval , Methylphenidate/pharmacokinetics , Methylphenidate/pharmacology , Pyridines/pharmacokinetics , Pyridines/pharmacology , Therapeutic Equivalency , United States , United States Food and Drug Administration , Zolpidem
15.
Clin Ther ; 32(10): 1704-12, 2010 Sep.
Article in English | MEDLINE | ID: mdl-21194592

ABSTRACT

BACKGROUND: Modified-release (MR) products are complex dosage forms designed to release drug in a controlled manner to achieve the desired efficacy and safety profiles. Inappropriate control of drug release from such products may result in reduced efficacy or increased toxicity. OBJECTIVE: This paper is a summary report of the American Association of Pharmaceutical Scientists, International Pharmaceutical Federation, and Product Quality Research Institute workshop titled "Challenges and Opportunities in Establishing Scientific and Regulatory Standards for Assuring Therapeutic Equivalence of Modified Release Products", held October 1-2, 2009, in Baltimore, Maryland. METHODS: The workshop provided an opportunity for pharmaceutical scientists from academia, industry, and regulatory agencies to discuss current regulatory expectations and industry practices for evaluating the pharmaceutical equivalence and bioequivalence of oral MR products. RESULTS: In the case of conventional monophasic MR formulations, the current regulatory approaches and criteria for bioequivalence evaluation were considered adequate for the assessment of therapeutic equivalence and inter-changeability of drug products. Additional measures may occasionally be needed to determine the bioequivalence of multiphasic MR products. The metric of partial AUC proposed by the US Food and Drug Administration received broad support as an additional measure for evaluating bioequivalence of multiphasic MR products designed to have a rapid onset of drug action followed by sustained response. The cutoff for partial AUCs may be based on the pharmacokinetic/pharmacodynamic or pharmacokinetic/ response characteristics of the products under examination. If the new metric is highly variable, the bioequivalence limits may be set based on the known within-subject variability for the reference product. CONCLUSIONS: The current regulatory approaches and criteria for bioequivalence evaluation were considered adequate for the assessment of therapeutic equivalence and interchangeability of conventional monophasic MR products. Additional measures may occasionally be needed to establish the bioequivalence of multiphasic MR products, and development of such measures is an important objective. The metric of partial AUC was proposed for products designed to have a rapid drug action followed by sustained response.

17.
Bioanalysis ; 1(1): 19-30, 2009 Apr.
Article in English | MEDLINE | ID: mdl-21083184

ABSTRACT

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.


Subject(s)
Drug Storage , Laboratories , Pharmaceutical Preparations/analysis , Pharmacokinetics , Biological Availability , Biotransformation , Calibration , Drug Contamination , Humans , Laboratories/standards , Pharmaceutical Preparations/metabolism , Quality Control , Reproducibility of Results , Therapeutic Equivalency , United States , United States Food and Drug Administration/standards
19.
AAPS J ; 9(3): E336-43, 2007 Oct 05.
Article in English | MEDLINE | ID: mdl-18170980

ABSTRACT

Bioanalytical methods used to support the drug development process are validated to ensure that they function in the manner in which they are intended. "Incurred" or study samples can vary in their composition when compared with the standards and quality control samples used to validate the method and analyze these samples. During the 3rd American Association of Pharmaceutical Scientists(AAPS)/Food and Drug Administration(FDA) Bioanalytical Workshop, it was suggested that the reproducibility in the analysis of incurred samples be evaluated in addition to the usual prestudy validation activities performed. This manuscript provides recommendations concerning the number and types of samples that should be analyzed in such an evaluation, as well as the manner in which the resultant data should be analyzed. Suggestions as to follow-up activities and data reporting are also discussed. This approach is at best a beginning and is offered as a platform for future discussion, comments, and revision.


Subject(s)
Chromatography, Liquid/methods , Enzyme-Linked Immunosorbent Assay/methods , Tandem Mass Spectrometry/methods , Reference Standards , Reproducibility of Results , Sensitivity and Specificity
20.
Br J Clin Pharmacol ; 62(2): 187-95, 2006 Aug.
Article in English | MEDLINE | ID: mdl-16842393

ABSTRACT

AIMS: A non-invasive proposed method for measuring CYP3A activity is the urinary 6beta-hydroxycortisol:cortisol ratio. This ratio has been used as an indicator of CYP3A induction and inhibition, with mixed results. This investigation evaluated the relationship between a validated, biomarker, intravenous midazolam clearance and the urinary cortisol ratio under constitutive conditions and with the influence of a moderate CYP3A inhibitor. METHODS: This was a sequential, cross-over study design. Intravenous midazolam 0.025 mg kg(-1) was administered to 10 male and 10 female subjects once every 14 days for 4 months. Fluvoxamine 150 mg day(-1) was given to all subjects during the last two visits. Total body clearance of midazolam and urinary 6beta-hydroxycortisol:cortisol molar ratio were used as biomarkers of hepatic CYP3A activity. RESULTS: No significant correlations were found between these two markers (r(2) < 0.5, P > 0.05). Larger interindividual and intra-individual variability in CYP3A activity was observed in 6beta-hydroxycortisol:cortisol ratios compared with midazolam clearances. With fluvoxamine therapy, midazolam clearance values decreased approximately 1.5-fold and cortisol ratios decreased approximately 1.9-fold. CONCLUSIONS: The high intra-individual variability of the urinary cortisol ratio, compared with midazolam, makes this a suboptimal CYP3A phenotyping tool.


Subject(s)
Biomarkers/blood , Cytochrome P-450 CYP3A/metabolism , Hydrocortisone/analogs & derivatives , Hydrocortisone/urine , Liver/enzymology , Midazolam/blood , Adult , Cross-Over Studies , Cytochrome P-450 CYP3A Inhibitors , Female , Fluvoxamine/pharmacology , Humans , Injections, Intravenous , Liver/drug effects , Male , Metabolic Clearance Rate , Midazolam/administration & dosage , Phenotype
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