An open label, single cohort, randomized, 4-period crossover Phase 1 study to determine the effect of meal timing relative to CRN00808 administration on the safety and pharmacokinetics of CRN00808 in healthy volunteers

开始日期2018-10-08

申办/合作机构

Crinetics Australia Pty Ltd.

[+1]

ACTRN12618001244291 / Suspended临床1/2期

A phase I/II study of povidone-iodine nasal spray (Nasodine”) to investigate safety and tolerability in healthy volunteers (Stage 1), and to investigate safety and efficacy in patients with the common cold (Stage 2).

开始日期2018-07-30

申办/合作机构

Firebrick Pharma Ltd.

[+1]

ACTRN12618001197224 / CompletedN/A

A single dose, cross-over pharmacokinetic study comparing oral formulations of BNC210 in healthy male volunteers

开始日期2018-07-19

申办/合作机构

Bionomics Ltd.

[+1]

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2019-06-01·Bioanalysis4区 · 医学

12th GCC Closed Forum: Critical Reagents; Oligonucleotides; CoA; Method Transfer; HRMS; Flow Cytometry; Regulatory Findings; Stability and Immunogenicity

4区 · 医学

Article

作者: Barry, Colin ; Garofolo, Wei ; Xiao, Yi Qun ; Goodwin, Lawrence ; Xu, Allan ; DuBey, Ira ; Islam, Rafiq ; Savu, Simona Rizea ; Hays, Amanda ; St Charles, Jessica ; Thomas, Eric ; Williard, Clark ; Hristopoulos, George ; Moussallie, Marc ; Couerbe, Philippe ; Bennett, Patrick ; Kakkanaiah, Vellalore ; Lindley, Kathie ; Satterwhite, Christina ; Keyhani, Anahita ; Beaver, Chris ; Caturla, Maria Cruz ; Fang, Xinping ; Sheldon, Curtis ; Malone, Michele ; Awaiye, Kayode ; Zimmer, Jennifer ; Ritzén, Hanna ; Cape, Stephanie ; Wells, Edward ; Yu, Mathilde ; Wang, Hao ; Dinan, Andrew ; Hughes, Nicola ; Williams, Dave ; Estdale, Sian ; Spriggs, Franklin ; Nehls, Corey ; Hayes, Roger ; Brown, Michael ; MacNeill, Robert ; Khadang, Ardeshir ; Briscoe, Chad ; Vija, Jenifer ; Tabler, Edward ; Lowes, Steve ; Savoie, Natasha ; Di Marco, Chantal ; Boulay, Iohann ; Karnik, Shane ; Kulagina, Nadia ; Lindsay, John ; Warren, Mark ; Bouhajib, Mohammed ; Lin, Jenny ; Rhyne, Paul ; Bourdage, James ; Stamatopoulos, John ; Matassa, Luca ; Tayyem, Rabab ; Stouffer, Bruce ; Xu, Arron

The 12th GCC Closed Forum was held in Philadelphia, PA, USA, on 9 April 2018. Representatives from international bioanalytical Contract Research Organizations were in attendance in order to discuss scientific and regulatory issues specific to bioanalysis. The issues discussed at the meeting included: critical reagents; oligonucleotides; certificates of analysis; method transfer; high resolution mass spectrometry; flow cytometry; recent regulatory findings and case studies involving stability and nonclinical immunogenicity. Conclusions and consensus from discussions of these topics are included in this article.

2019-04-01·Bioanalysis4区 · 医学

Recommendations for Classification of Commercial LBA Kits for Biomarkers in Drug Development From the GCC for Bioanalysis

4区 · 医学

Article

作者: Keyhani, Anahita ; Hughes, Nicola ; Williard, Clark ; Malone, Michele ; Bourdage, James ; Satterwhite, Christina ; Warren, Mark ; Lin, Jenny ; Zimmer, Jennifer ; Kulagina, Nadia ; Bouhajib, Mohammed ; Barry, Colin ; Nehls, Corey ; Stamatopoulos, John ; Wang, Hao ; Kakkanaiah, Vellalore ; Thomas, Eric ; Savu, Simona Rizea ; Wells, Edward ; Briscoe, Chad ; Brown, Michael ; Kar, Sumit ; Cape, Stephanie ; Lindley, Kathie ; DiMarco, Chantal ; Hayes, Roger ; MacNeill, Robert ; Couerbe, Philippe ; St Charles, Jessica ; Yu, Mathilde ; Awaiye, Kayode ; Vija, Jenifer ; Spriggs, Franklin ; DiMarco, Luigi ; Cruz Caturla, Maria ; Garofolo, Wei ; Lindsay, John ; Hays, Amanda ; Karnik, Shane ; Sheldon, Curtis ; Feng, Hao ; Xu, Allan ; Dinan, Andrew ; DuBey, Ira ; Bennett, Patrick ; Savoie, Natasha ; Goodwin, Lawrence ; Fang, Xinping ; Moussallie, Marc ; Tabler, Edward ; Williams, Dave ; Boulay, Iohann ; Islam, Rafiq ; Ritzén, Hanna ; Xiao, Yi Qun ; Rhyne, Paul ; Stouffer, Bruce ; Tayyem, Rabab ; Hristopoulos, George ; Beaver, Chris ; Estdale, Sian ; Khadang, Ardeshir ; Xu, Arron

Over the last decade, the use of biomarker data has become integral to drug development. Biomarkers are not only utilized for internal decision-making by sponsors; they are increasingly utilized to make critical decisions for drug safety and efficacy. As the regulatory agencies are routinely making decisions based on biomarker data, there has been significant scrutiny on the validation of biomarker methods. Contract research organizations regularly use commercially available immunoassay kits to validate biomarker methods. However, adaptation of such kits in a regulated environment presents significant challenges and was one of the key topics discussed during the 12th Global Contract Research Organization Council for Bioanalysis (GCC) meeting. This White Paper reports the GCC members’ opinion on the challenges facing the industry and the GCC recommendations on the classification of commercial kits that can be a win-win for commercial kit vendors and end users.

2018-04-01·Bioanalysis4区 · 医学

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

4区 · 医学

Article

作者: Tudoroniu, Ariana ; Garofolo, Wei ; Spriggs, Franklin ; Savoie, Natasha ; Hulse, James ; Bouhajib, Mohammed ; Fatmi, Saadya ; van der Strate, Barry ; Wilfahrt, Jim ; Warren, Mark ; Williard, Clark ; Fountain, Scott ; Bourdage, James ; Beaver, Chris ; Arnold, Mark ; Zemo, Jennifer ; Hayward-Sewell, Joanne ; Colletti, Kelly ; Karnik, Shane ; DuBey, Ira ; Brant, Ashley ; Patel, Vimal ; Dinan, Andrew ; Liu, Yansheng ; Lin, Jenny ; Sanchez, Christina ; Stouffer, Bruce ; Datin, Jim ; Yamashita, Jim ; Fang, Xinping ; Iordachescu, Adriana ; Sikkema, Daniel ; Briscoe, Chad ; Ray, Gene ; Stamatopoulos, John ; Khadang, Ardeshir ; Lindsay, John ; Xu, Allan ; Brown, Michael ; Yu, Mathilde ; Xiao, Yi Qun ; Wells, Edward ; Hayes, Roger ; Cape, Stephanie ; Boudreau, Nadine ; Papac, Damon ; Hristopoulos, George ; Warrino, Dominic ; Caturla, Maria Cruz ; Tayyem, Rabab ; Keyhani, Anahita ; Couerbe, Philippe ; Khan, Masood ; Tabler, Edward ; Zimmer, Jennifer ; Tu, Jing ; Kennedy, Michael ; Sheldon, Curtis ; Marcelletti, John ; St Charles, Jessica ; Vija, Jenifer ; Satterwhite, Christina ; Islam, Rafiq ; Joyce, Philip ; Nehls, Corey ; Ohorodnik, Susan ; Green, Rachel ; Barry, Colin ; Bower, Joseph ; Buonarati, Mike ; Hughes, Nicola

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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