7th GCC Insights: Incurred Samples Use; Fit-For-Purpose Validation, Solution Stability, Electronic Laboratory Notebook and Hyperlipidemic Matrix Testing

Rocci, Mario L.; Lowes, Steve; Shoup, Ronald E.; Garofolo, Fabio; Farmen, Raymond H.; Zhang, Tianyi; Allinson, John; Gouty, Dominique; Hayes, Roger N.; Nicholson, Robert Ian; Houghton, Richard; Dumont, Isabelle; LeLacheur, Richard; Zimmer, Jennifer; Caturla, Maria Cruz; Couerbe, Philippe; Awaiye, Kayode; Fatmi, Saadya; Sheldon, Curtis; Bower, Joseph F.; Fiscella, Michelle; Fast, Douglas M.; Cape, Stephanie; Hulse, Jim; Kamerud, John; Pasas-Farmer, Stephanie; Garofolo, Wei; Moussallie, Marc; Buonarati, Mike; Boudreau, Nadine; Pellerin, Brigitte; Lin, Jenny; Xu, Allan; Bouhajib, Mohammed; Stipancic, Mary; Nehls, Corey; Warren, Mark S.; Karnik, Shane; Stovold, Craig; Reuschel, Scott; Cojocaru, Laura; Marcelletti, John F.; Fang, Xinping; Smith, Ian; Watson, Andrea

doi:10.4155/bio.14.231

Cited by 18 publications

(15 citation statements)

References 16 publications

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“…It was concluded during the 7th GCC meeting [5] that a FFP approach should be limited to demonstrating acceptable assay performance when alternatives to challenging assays are not available.…”

Section: Applications Of Fit-for-purpose Validationmentioning

confidence: 99%

11th GCC Closed Forum: Cumulative Stability; Matrix Stability; Immunogenicity assays; Laboratory Manuals; Biosimilars; Chiral methods; Hybrid LBA/LCMS Assays; Fit-for-Purpose Validation; China Food and Drug Administration Bioanalytical Method Validation

Islam¹,

Briscoe²,

Bower³

et al. 2018

Bioanalysis

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The 11th Global CRO Council Closed Forum was held in Universal City, CA, USA on 3 April 2017. Representatives from international CRO members offering bioanalytical services were in attendance in order to discuss scientific and regulatory issues specific to bioanalysis. The second CRO-Pharma Scientific Interchange Meeting was held on 7 April 2017, which included Pharma representatives' sharing perspectives on the topics discussed earlier in the week with the CRO members. The issues discussed at the meetings included cumulative stability evaluations, matrix stability evaluations, the 2016 US FDA Immunogenicity Guidance and recent and unexpected FDA Form 483s on immunogenicity assays, the bioanalytical laboratory's role in writing PK sample collection instructions, biosimilars, CRO perspectives on the use of chiral versus achiral methods, hybrid LBA/LCMS assays, applications of fit-for-purpose validation and, at the Global CRO Council Closed Forum only, the status and trend of current regulated bioanalytical practice in China under CFDA's new BMV policy. Conclusions from discussions of these topics at both meetings are included in this report.

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Section: Applications Of Fit-for-purpose Validationmentioning

confidence: 99%

11th GCC Closed Forum: Cumulative Stability; Matrix Stability; Immunogenicity assays; Laboratory Manuals; Biosimilars; Chiral methods; Hybrid LBA/LCMS Assays; Fit-for-Purpose Validation; China Food and Drug Administration Bioanalytical Method Validation

Islam¹,

Briscoe²,

Bower³

et al. 2018

Bioanalysis

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“…The survey sent to CRO membership and pharma companies was designed to gauge experience with their use after several years of discussion within this forum [5,7].…”

Section: Elns and Data Integritymentioning

confidence: 99%

“…Attendees of these Closed Forum meetings discuss several interesting subjects related to bioanalytical CROs. In order to advance industry thinking on the topics discussed, conference reports [2][3][4][5][6][7] and white papers [8][9][10][11][12][13] are available summarizing the opinions and unique challenges CROs face as well as recommendations for several approaches to a wide range of topics across the c ommunity.…”

mentioning

confidence: 99%

The 10th GCC Closed Forum: Rejected Data, GCP in Bioanalysis, Extract Stability, BAV, Processed Batch Acceptance, Matrix Stability, Critical Reagents, Eln and Data Integrity and Counteracting Fraud

Cape¹,

Islam²,

Nehls³

et al. 2017

Bioanalysis

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The 10th Global CRO Council (GCC) Closed Forum was held in Orlando, FL, USA on 18 April 2016. In attendance were decision makers from international CRO member companies offering bioanalytical services. The objective of this meeting was for GCC members to meet and discuss scientific and regulatory issues specific to bioanalysis. The issues discussed at this closed forum included reporting data from failed method validation runs, GCP for clinical sample bioanalysis, extracted sample stability, biomarker assay validation, processed batch acceptance criteria, electronic laboratory notebooks and data integrity, Health Canada's Notice regarding replicates in matrix stability evaluations, critical reagents and regulatory approaches to counteract fraud. In order to obtain the pharma perspectives on some of these topics, the first joint CRO–Pharma Scientific Interchange Meeting was held on 12 November 2016, in Denver, Colorado, USA. The five topics discussed at this Interchange meeting were reporting data from failed method validation runs, GCP for clinical sample bioanalysis, extracted sample stability, processed batch acceptance criteria and electronic laboratory notebooks and data integrity. The conclusions from the discussions of these topics at both meetings are included in this report.

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“…However, the optimum test items and study design are still obscure [12]. Given that GBC [5], the 7th WRIB [10], and 7th GCC [6] recommended evaluating ISS when metabolites are likely to affect assay results, it is important to discuss the test items and study design of ISS experiments in the presence of AG. Unfortunately, to my knowledge, ISS in the presence of AG has been addressed by only two case studies [13,14].…”

Section: Introductionmentioning

confidence: 99%

“…Stability tests using incurred samples are called "incurred sample stability (ISS)" [5]. ISS is the subject of intense debate within Global Bioanalysis Consortium (GBC) [5], Global CRO Council for Bioanalysis (GCC) [6,7], European Bioanalysis Forum (EBF) [8], Workshop on Recent Issues in Bioanalysis (WRIB) [9,10], and Japan Bioanalysis Forum [11]. However, the optimum test items and study design are still obscure [12].…”

Section: Introductionmentioning

confidence: 99%

Incurred sample stability of ASP3258 in the presence of its acyl glucuronide

Ohtsu¹

2017

J Appl Bioanal

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The acyl glucuronide (AG) of ASP3258 was abundant in incurred monkey samples, and because an AG generally back-converts to its aglycone, accurate quantification of ASP3258 in monkey plasma was a challenge. To prevent the back-conversion of ASP3258-AG, cooling and acidification were incorporated during sample collection, storage, and extraction. To demonstrate that the AG did not affect the determination of ASP3258, the present study used incurred samples to examine whole blood stability, short-term stability, freeze-thaw stability, frozen stability, and stability during extraction. The concentration changes were within −11.4% to 15.0% compared with a reference value and were therefore judged acceptable. The present study presents a detailed account of test items, a reference value, sample numbers, sample selection, and an equation for assessment in the incurred sample stability tests. This bioanalytical method was applied successfully to a study of the toxicokinetics of ASP3258 in monkeys.Keywords: incurred sample stability, acyl glucuronide, ASP3258, animal plasma, toxicokinetics. IntroductionThe potent phosphodiesterase 4 inhibitor ASP3258 (Figure 1) is a novel therapeutic agent for asthma and chronic obstructive pulmonary disease [1]. We previously developed and validated a bioanalytical method to quantify ASP3258 in rat plasma [2]. Because ASP3258 metabolite was not detected in rat plasma [3], this bioanalytical method was developed without encountering issues associated with the metabolite. Subsequently, monkey toxicity studies were planned that required an appropriate bioanalytical method. When ASP3258 was orally administered to monkeys in a preliminary study, the acyl glucuronide (AG) metabolite of ASP3258 was detected in abundance in monkey plasma (data on file), in contrast to our findings using rat plasma [3]. In general, AGs readily back-convert to aglycones, causing overestimation of

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7th GCC Insights: Incurred Samples Use; Fit-For-Purpose Validation, Solution Stability, Electronic Laboratory Notebook and Hyperlipidemic Matrix Testing

Cited by 18 publications

References 16 publications

11th GCC Closed Forum: Cumulative Stability; Matrix Stability; Immunogenicity assays; Laboratory Manuals; Biosimilars; Chiral methods; Hybrid LBA/LCMS Assays; Fit-for-Purpose Validation; China Food and Drug Administration Bioanalytical Method Validation

11th GCC Closed Forum: Cumulative Stability; Matrix Stability; Immunogenicity assays; Laboratory Manuals; Biosimilars; Chiral methods; Hybrid LBA/LCMS Assays; Fit-for-Purpose Validation; China Food and Drug Administration Bioanalytical Method Validation

The 10th GCC Closed Forum: Rejected Data, GCP in Bioanalysis, Extract Stability, BAV, Processed Batch Acceptance, Matrix Stability, Critical Reagents, Eln and Data Integrity and Counteracting Fraud

Incurred sample stability of ASP3258 in the presence of its acyl glucuronide

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