The 1st Workshop in Asia Pacific
on Recent Issues in GLP Regulated Bioanalysis
Preliminary Program
Updates from Asia Pacific Regulatory Agencies & Health Authorities:
- Hear from experts from China SFDA, India CDSCO, Japan MHLW-NIHS, Korea KFDA, and Malaysia BPFK on updates of the status of GLP Regulated Bioanalysis in Asia Pacific
- Regulation Developments: Implication for conducting GLP regulated bioanalysis in Asia Pacific
- National and international applications for conducting clinical pharmacokinetic and bioequivalence studies in Asia Pacific
- Agencies' perspective on Global Harmonization of Bioanalytical Guidelines
USA FDA Bioanalytical Guidance Revision and New Europe EMA Bioanalytical Guidance:
- Updates from U.S. FDA: FDA Bioanalytial Guidance Revision and updates from White Papers, new issues, cautionary notes
- Updates from European Medical Agency (EMA): New Draft Bioanalytical Guidance - Committee for Medicinal Products for Human Use (CHMP) on Validation of Bioanalytical Methods
- Major differences among EMA guidance, 2001 FDA guidance, and White Papers
- Comparing bioanalytical guidance among North America (U.S. FDA), Europe (EMA), and Asia
Global Harmonization of Bioanalytical Guidelines:
- "Bioanalytical Science is Universal!"
- Is harmonization possible?
- What is the best/fastest way to achieve it?
- Review of multiple national guidance and limited comprehensive guidance
- Simple, globally harmonized guidance should be of equal interest to both the regulators and practitioners of bioanalysis
- Main characteristic of the Global Bioanalytical Guidance
- The Global Bioanalytical Consorsium: scope, operations, structure, activities
Current Challenges in Bioanalysis:
- Evaluation of the Regression Type in LC-MS/MS Bioanalytical Methods
- US FDA guidelines for bioanalytical method validation clearly state that the simplest model that adequately describes the concentration-response relationship should be used
- In many bioanalytical methods, the range only fits complex regression equations or requires the dilution of higher concentration samples to fit a linear regression
- Bioanalytical regulations do not mention which is the best approach to follow
- This topic is still highly debated in the pharmaceutical industry with supporters of linear fit vs. supporter of quadratic fit
- How to Increase Quality & Performance of Bioanalytical Methods
- Instruments/techniques that can improve quality & performance in regulated bioanalysis
- Industry experience on the latest bioanalytical technique available
- The Most Recent Update in Using Dried Blood Spots (DBS) in Regulated Bioanalysis
- Robust Technology to support validated methods to internationally accepted criteria
- Sample Preparation & Analysis
- Quantitation by validated LC-MS/MS assay
- ISR for DBS methods
- Understanding and Implementation of DBS: Drying time; Cross-contamination; Optimized and universal extractions procedures; Effects of hematocrit; Future Directions
- Ligand Binding Assays (LBA) Recent and Old Challenges and Solutions
- Validation of large molecules: specificity, selectivity and non linear calibration
- LBA Free/Total
- LBA new technologies available: pros and cons: Ligand binding assay format; Possible changes that could require cross-validation; Risk-based strategy for cross-validation
- Orthogonal methods to complement LBA for biotherapeutics and why do we need them?
- Limitations of Quantitative LC-MS/MS: The Macrolide Immunosuppressant Drugs Case Study
- Limitations of LC-MS/MS as a bioanalytical technique for the quantitation of Sirolimus, Tacrolimus and Everolimus
- Specific extraction procedures to disrupt red blood cells and to minimize ion suppression
- Systematic evaluation of LC-MS/MS parameters that influence sensitivity and Matrix effect
- Incurred Samples Reanalysis (ISR): How to Investigate ISR Failure: Real Case Studies & Lessons Learnt
- Evaluation of different approaches that can be used when investigating failures encountered during incurred sample reanalysis (ISR) experiments
- On the basis of these failures and their resolution what lessons can be learned?
- Monitoring of assay performance and sample results and thoroughly investigate any unusual findings
- Complexity, scope and duration of investigations to address failed ISR assessment
- Assessment of potential impact of technical procedures on assay performance
- Latest Data on How Unstable Metabolites can Impact Bianalytical Assay Performance
- Thorough evaluation of drug biotransformation during Regulated Bioanalysis
- Evaluation the possible impact of unstable metabolites on drug quantification
- Case studies on lactones, N-oxides, and acyl glucuronides that may revert back to the parent drug
- Regulatory Challenges in the Analysis of Biomarkers
- Technical challenges in providing quantitative analysis in a regulated environment for Biomarker
- Handling the endogenous presence of the analyte
- Development of a Regulatory Guidance able to meet the growing industry demand in this field
- Fit-for-purpose philosophy for biomarkers quantification: screening vs. qualified vs. validated method
New or Emerging Guidelines on Method Development and Validation:
- The most recent industry standards and regulatory agencies perspective on which extra tests performed during method development should be re-performed during the validation
- Hemolysis testing: it is a special case of matrix effect; Possible impact on Quantitation & Chromatography; There is no guidance
- Metabolite testing: Sample processing; Sample preparation; In-source
- Variable injection volumes: Saturation of system; Chromatography overload; Ionization suppression/enhancement; Column blockage
- Cross-validation between different anticoagulant salt forms: EDTA: K2, K3, Na; Heparin: Na, Li; There is no literature available
