Publications by authors named "Philip Joyce"

7 Publications

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GCC Consolidated Feedback to ICH on the 2019 ICH M10 Bioanalytical Method Validation Draft Guideline.

Bioanalysis 2019 Sep 30;11(18s):1-228. Epub 2019 Sep 30.

WuXi Apptec, Shanghai, China.

The 13 GCC Closed Forum for Bioanalysis was held in New Orleans, Louisiana, USA on April 5, 2019. This GCC meeting was organized to discuss the contents of the 2019 ICH M10 Bioanalytical Method Validation Draft Guideline published in February 2019 and consolidate the feedback of the GCC members. In attendance were 63 senior-level participants from eight countries representing 44 bioanalytical CRO companies/sites. This event represented a unique opportunity for CRO bioanalytical experts to share their opinions and concerns regarding the ICH M10 Bioanalytical Method Validation Draft Guideline and to build unified comments to be provided to the ICH.
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http://dx.doi.org/10.4155/bio-2019-0207DOI Listing
September 2019

Military Service Member Perspectives About Occupational Therapy Treatment in a Military Concussion Clinic.

OTJR (Thorofare N J) 2019 10 22;39(4):232-238. Epub 2018 Nov 22.

Naval Hospital Camp Pendleton, Salt Lake City, UT, USA.

The purpose of this study is to describe important features of occupational therapy practice for treatment of military service members with chronic symptoms and a history of mild traumatic brain injury (mTBI) in a military concussion care clinic from service members' perspectives with support from occupational therapy practitioners. Two series of focus groups were conducted with service members with chronic mTBI-related symptoms ( = 6) and practitioners ( = 5). Data were analyzed concurrently with collection. We identified five main themes: therapeutic relationship, consistent inclusion of family members, combat versus noncombat injuries, loss of military identity, and assessment against population norms. The findings of this study suggest that service members' evaluations of occupational therapy are based on the overall experience of the encounter, centered by the therapeutic relationship, rather than specific intervention strategies or technology.
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http://dx.doi.org/10.1177/1539449218813849DOI Listing
October 2019

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.

Bioanalysis 2018 Apr 27;10(7):433-444. Epub 2018 Apr 27.

Worldwide Clinical Trials, Austin, TX, USA.

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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http://dx.doi.org/10.4155/bio-2018-0014DOI Listing
April 2018

Highly selective and sensitive measurement of active forms of FGF21 using novel immunocapture enrichment with LC-MS/MS.

Bioanalysis 2018 Jan 14;10(1):23-33. Epub 2017 Dec 14.

Bioanalytical Sciences, Research & Development, Bristol-Myers Squibb Co., Route 206 & Province Line Road, Princeton, NJ 08543, USA.

Aim: Recombinant FGF21 analogs are under wide ranging investigations as a potential therapeutic agent for Type 2 diabetes, as well as other metabolic disorders. The endogenous FGF21 is often used as a surrogate pharmacodynamic(PD) biomarker to assess drug efficacy and safety. Results & methodology: Immunocapture was performed using a monoclonal antibody which had been generated to bind to specific domain of native FGF21 as the capture reagent. After immunocapture, enzymatic digestion was performed and a native FGF21-specific tryptic peptide was monitored using LC-MS/MS by selective reaction monitoring.

Conclusion: We have successfully developed and validated a bioanalytical assay which provides the specificity to differentiate the endogenous FGF21 from the recombinant therapeutic agent which has nearly identical sequence to the endogenous molecule.
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http://dx.doi.org/10.4155/bio-2017-0208DOI Listing
January 2018

Overcoming interference with the detection of a stable isotopically labeled microtracer in the evaluation of beclabuvir absolute bioavailability using a concomitant microtracer approach.

J Pharm Biomed Anal 2017 Sep 17;143:9-16. Epub 2017 May 17.

Covance Laboratories Inc., Ewing, NJ, USA.

The oral absolute bioavailability of beclabuvir in healthy subjects was determined using a microdose (100μg) of the stable isotopically labeled tracer via intravenous (IV) infusion started after oral dosing of beclabuvir (150mg). To simultaneously analyze the concentrations of the IV microtracer ([C]beclabuvir) and beclabuvir in plasma samples, a liquid chromatography-triple quadrupole mass spectrometry (LC-MS/MS) method was initially developed. Surprisingly beclabuvir significantly interfered with the IV microtracer detection when using the selected reaction monitoring (SRM) in the assay. An interfering component from the drug substance was observed using a high resolution mass spectrometer (HRMS). The mass-to-charge (m/z) of the interfering component was -32ppm different from the nominal value for the IV microtracer and thus could not be differentiated in the SRM assay by the unit mass resolution. To overcome this interference, we evaluated two approaches by either monitoring an alternative product ion using the SRM assay or isolating the interfering component using the parallel reaction monitoring (PRM) assay on the HRMS. This case study has demonstrated two practical approaches for overcoming interferences with the detection of stable isotopically labeled IV microtracers in the evaluation of absolute bioavailability, which provides users the flexibility in using either LC-MS/MS or HRMS to mitigate unpredicted interferences in the assay to support microtracer absolute bioavailability studies.
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http://dx.doi.org/10.1016/j.jpba.2017.04.030DOI Listing
September 2017

Considerations of electronic medications management systems in hospital setting.

Authors:
Philip Joyce

Stud Health Technol Inform 2012 ;178:83-91

Swinburne University, Victoria, Australia.

Electronic systems that support clinicians in the task of medication management are now being developed and implemented in the hospital setting. Electronic Medications Management Systems provide support to all the stakeholders within the process of medications and support for the patient centric care model. In this paper we discuss the key elements an electronic medications management systems should possess and what type of these key elements it should possess from a clinical/health information manager perspective. Moreover, the paper considers how it could integrate Electronic Medications Management Systems within the current health information architecture with an acute care hospital.
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November 2012

The effect of guanethidine and local anesthetics on the electrically stimulated mouse vas deferens.

Anesth Analg 2002 Nov;95(5):1339-43, table of contents

University Department of Anaesthesia and Pain Management, Leicester Royal Infirmary, Leicester LE1 5WW, UK.

Unlabelled: Complex regional pain syndrome is often treated with the sympatholytic guanethidine and a local anesthetic in a Bier's block. The efficacy of this treatment has been questioned. Because local anesthetics inhibit the norepinephrine uptake transporter, we hypothesized that this variable efficacy results from the local inhibiting the uptake of guanethidine. In this study, we tested this hypothesis by using a sympathetically innervated mouse vas deferens preparation. Organ bath-mounted mouse vasa deferentia were electrically stimulated in the absence and presence of guanethidine, prilocaine, procaine, and cocaine in various combinations. Prilocaine (1 mM) induced an immediate inhibition of twitch response (maximum 100% after 2 min) that fully reversed after washing. Guanethidine (3 microM) also inhibited twitching by 95% +/- 3% in 15 min, but this effect was only partially reversed after 1 h of washing (33% +/- 12% of control). When prilocaine and guanethidine were added in combination, a reversal of 80% +/- 13% (at 1 h) was observed. Procaine (300 micro M) produced a transient increase (152% +/- 14%) in response. When co-incubated with guanethidine (3 microM), the twitch was reduced to 24% +/- 4% of control and was reversed to 77% +/- 7% after 1 h. Cocaine (30 microM) inhibited the twitch response to 53% +/- 8%, which was fully reversed by 1 h of washing. When co-incubated with guanethidine, the response was reduced to 39% +/- 6% of control and was reversed to 86% +/- 10% after 1 h. In all cases, the reversal produced by the combination was significantly more intense (P < 0.05) than that produced by guanethidine alone. Local anesthetics reduce the sympatholytic actions of guanethidine, and this may explain the variable efficacy of guanethidine in the treatment of complex regional pain syndrome.

Implications: In this study, with a sympathetically innervated vas deferens preparation, local anesthetics reduced the efficacy of the sympatholytic guanethidine, questioning its co-administration in the pain clinic.
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http://dx.doi.org/10.1097/00000539-200211000-00045DOI Listing
November 2002