Guideline・Guidance

• BMV guidance by FDA
  『Bioanalytical Method Validation Guidance for Industry (2018)』
  Category：guidance／Relevance：LC/MS・LBA・PK・Small molecule・biological drug・BM
• BMV guidance by EMA
  『Guideline on bioanalytical method validation (2011)』
  Category：guidance／Relevance：LC/MS・LBA・PK・Small molecule・biological drug・BM
• BMV guidance by the Ministry of Health, Labor and Welfare
  『Guideline on Bioanalytical Method Validation in Pharmaceutical Development (2013)』
  『Guideline on Bioanalytical Method（Ligand Binding Assay）Validation in Pharmaceutical Development (2014)』
  Category：guidance／Relevance：LC/MS・LBA・PK・Small molecule・biological drug・BM
• Documents that provide comprehensive guidance for biomarker analysis in Pharmaceutical Development
  『Points to Consider Document: Scientific and Regulatory Considerations for the Analytical Validation of Assays Used in the Qualification of Biomarkers in Biological Matrices (2019)』
  Category：guidance・white paper／Relevance：LC/MS・LBA・PK・Small molecule・biological drug・BM
• AMED biomarker research group LC-MS / LBA biomarker analysis method validation paper
  『Analytical method validation for biomarkers as a drug development tool: points to consider』
  Category：guidance・white paper／Relevance：LC/MS・LBA・Small molecule・biological drug・BM
• AMED biomarker research group qPCR biomarker analysis method validation paper
  『Development and validation of qPCR methods for nucleic acid biomarkers as a drug development tool: points to consider』
  Category：guidance・white paper／Relevance：PCR・nucleic acid・BM
• Papers that are the actual basis for setting ADA/NAb Cut points
  『Recommendations for the validation of immunoassays used for detection of host antibodies against biotechnology products』
  『Recommendations for Systematic Statistical Computation of Immunogenicity Cut Points』
  『Statistical evaluation of several methods for cut-point determination of immunogenicity screening assay』
  
  Category：guidance・white paper・paper／Relevance：LBA・ADA・biological drug
• Long-term storage is confirmed for binding and functional serum antibodies for up to 4.6 years below -65°C and for up to 2.5 years at -20°C in controlled cold storage, which may be extended after longer follow-up.
  『Stability studies of binding and functional anti-vaccine antibodies (2014)』
  Category：guidance・white paper・paper／Relevance：LBA・biological drug
• European immunogenicity platform. You can browse the symposium materials for each year from “Symposiums” at the top of the homepage.
  『European Immunogenicity Platform homepage』
  Category：guidance・white paper・paper・home page (document)／Relevance：LBA・ADA・biological drug
• You can browse past symposiums and workshop materials from "Past Conferences" at the bottom of the link.
  『European Bioanalysis Forum "Conferences"』
  Category：guidance・white paper・paper・home page (document)
• ADA-related guidance by FDA
  『Immunogenicity Testing of Therapeutic Protein Products-Developing and Validating Assays for Anti-Drug Antibody Detection (2019)』
  Category：guidance／Relevance：LBA・ADA・biological drug
• ADA-related guidance by EMA
  『Guideline on Immunogenicity assessment of therapeutic proteins (2017)』
  Category：guidance／Relevance：LBA・ADA・biological drug
• Comparison of polar guidance / guidelines on LBA
  『Guideline/Guidance Comparison on Ligand Binding Assays (LBA) (2018)』
  Category：guidance・white paper・paper・home page (document) ／Relevance：LBA・PK・biological drug
• A workshop held by CFABS (Canadian Forum for Analytical and Bioanalytical Sciences).
  You can browse past white papers from the "Previous white papers" button.
  『WRIB (Workshops on Recent Issues in Bioanalysis)』
  Category：guidance・white paper・paper・home page (document)
• Template for measurement test of concentration in biological sample in US approval application
  『Bioanalytical Methods Templates Guidance for Industry (2019)』
  Category：guidance／Relevance：PK