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Bioanalytical Testing Under GMP: Optimizing Cell-Based Potency Assays

Recommendations for the Development and Validation of Immunogenicity Assays in Support of Biosimilar Programs

Immunogenicity Assessment of Gene Therapy Compounds

Supporting CAR-T Therapies, Part 1: Innovation to Overcome Bioanalytical Challenges

BioAgilytix Team Q&A: Meet Tatjana Ackermann, Quality Assurance Auditor

CRISPR-Cas9 Milestones: The First In Vivo Clinical Trial Is Now Underway in Boston

Scientific Focus: Immunogenicity Testing for Gene and Cell Therapies

“The History & Future of Gene Therapy” Infographic

BioAgilytix Team Q&A: Meet Janett Schwarz, Principal Investigator at BioAgilytix

Event Line-Up: The Bioanalytical Industry Forums We’ll Be at This Fall

Your Questions About Exploratory Biomarker Testing Answered

BioAgilytix Team Q&A: Meet Eric Nesbit, Bioanalytical Project Manager/Scientist III

In Review: Evaluating the New ICH M10 Guideline Draft

On-Demand Webinar: Exploratory Biomarker Testing – to Qualify or Validate the Assay?

BioAgilytix Team Q&A: Meet Jelle Hempenius, Business Development Director, Europe

Webinar Sneak Peek: Exploratory Biomarker Testing—to Qualify or Validate the Assay?

Gene Therapy Trends: Conditional Approval of Zynteglo Brings Ex Vivo Gene Therapy Into Focus

ICH M10 Guideline Draft: Are Standard Report Templates Efficient, Feasible, and Practical?

The Direct & Prescriptive 2019 ICH M10 Guideline Draft

How the ICH M10 Guideline Draft Will Influence Sponsors & SOPs

C-Path “Points to Consider Document” Clarifies Bioanalytical Assay Validation in Support of Clinical Biomarker Qualification

ICH M10 Guideline Draft: Differing Analytical Methods of the QC in Validation Processes

Platform Spotlight: ImmunoCAP to Support Diagnosis of Allergic Reactions Against Biologics

Panel discussion: ICH M10 draft bioanalytical method validation guideline

Immunogenicity Assessment Using the Biacore™ T200 SPR System

510K Approved Assays vs. RUO Assays: Which Best Support Clinical Trial Biomarker Studies?

To the Rescue: Applying a Novel Approach to Minimize False Positive ADA Assay Results

Why Biology Matters: The Key to Successful Biomarker Validation

BioAgilytix Team Q&A: Meet Mike Losauro, Senior Business Development Director at BioAgilytix

Your Questions About Immunogenicity Assessment of Gene Therapy Compounds Answered

Points to Consider Document: Scientific and Regulatory Considerations for the Analytical Validation of Assays Used in the Qualification of Biomarkers in Biological Matrices, June 2019

Novel Approach to ADA Assay Development to Overcome Target Interference Issues from Dimerization

A History of Gene Therapy: Exploring Lessons Learned In Light of New Approvals

On-Demand Webinar: Principles of Immunogenicity Assessment Using Biacore™ T200 SPR System

Key Takeaways from the 13th Annual WRIB, 2019

Webinar Recording: Immunogenicity assessment of gene therapy compounds: discussion on current and future concepts

Podcast Feature: Enabling the Breakthroughs of Tomorrow, Today

Immunogenicity Assessment of Gene Therapy Compounds

What Drives BioAgilytix’s #TeamBehindtheScience?

BioAgilytix Team Q&A: Meet Charlie Walker, Associate Director of Finance at BioAgilytix

The Fit for Flow Cytometry, Part 1: Ideal for Receptor Occupancy Assessment

Podcast: Enabling Tomorrow’s Breakthroughs Today

BioAgilytix Team Q&A: Meet Corinna Fiorotti, Scientific Officer and Key Accounts Director

New FDA Guidance on Developing and Validating Assays for ADA Detection: Key Updates and Clarifications

Key Takeaways from Oxford Global’s 14th Annual Biomarkers Congress

Platform Spotlight: ProteinSimple Ella™ for Accurate and Reproducible Multiplex Biomarker Analysis

Creating Neutralizing Antibody Assays for the Identification of Antibodies Against Adeno-Associated Virus for Gene Therapy

Supporting a Gene Therapy Clinical Trial with Assay to Measure NAbs Against the AAV9 Serotype

A Dose of Pharma and Biotech News: February 13, 2019

BioAgilytix Team Q&A: Meet David Rusnak, Director of Laboratory Systems and Automation at BioAgilytix

The FDA’s Response to an Increase in the Development of Gene and Cell Therapies: What It Means for Sponsors

BioAgilytix Team Q&A: Meet Gabi Schewe, Lab Manager at BioAgilytix Europe

Immunogenicity Testing of Therapeutic Protein Products —Developing and Validating Assays for Anti-Drug Antibody Detection, January 2019

Ligand-Binding Assay Optimization, Part 1: Critical Attributes of Platforms Used

Webinar Recap: Your Questions About Unwanted Drug-Induced Immune Responses

Have a Slipping Study? Don’t Change Your Assay, Change Your CRO

Key Takeaways from 2018’s AAPS PharmSci 360

Bioanalytical Outsourcing: Sidestepping the Pitfalls to Ensure Project Success

Webinar Sneak Peek: Clinical Relevance of (Unwanted Drug-Induced) Immune Responses

Webinar Recording: Clinical relevance of (unwanted drug-induced) immune responses

BioAgilytix Partnership Across Continents: Meet William Hunter and Todd Lester

Making an Impact: Molecular Biomarkers Inform the Drug Development Process for Large and Small Molecule Drugs

BioAgilytix Team Q&A: Meet Yang Liu, Associate Director at BioAgilytix Europe

BioAgilytix Team Q&A: Meet Dave Williams, Director, Bioanalytical Operations at BioAgilytix

A Dose of Pharma and Biotech News: September 19, 2018

New Research on the Diagnostic Journey of Patients with Ankylosing Spondylitis

Platform Spotlight: Biacore™ to Detect and Characterize ADAs in Immunogenicity Studies

Using Partnerships to Guide New Bioanalytical Technology Investments

The Evolution of Bioanalytical Outsourcing Partnerships

Business of Bioanalysis: Differing Priorities and Requirements in Choosing Platforms

BioAgilytix Team Q&A: Meet Sarah Rieveschl, Business Development Director at BioAgilytix

Setting Yourself Up for Success: Advice for Early Career Scientists

The Challenges Associated with Implementing New Bioanalytical Technologies

Business of Bioanalysis: Focusing on the Bioanalytical Data’s End Use

BioAgilytix Team Q&A: Meet Dominic Phan, Business Development Associate at BioAgilytix

Business of Bioanalysis: Building Strong Partnerships with Sponsor Companies

Examining the Demand for New Bioanalytical Technologies as a Contract Research Organization

Business of Bioanalysis: Changing Trends & the Impact on New Technologies

Attracting and Retaining Scientific Talent in a Complex, Competitive Industry

Business of Bioanalysis: Reverse Engineering Technology Requirements

BioAgilytix Team Q&A: Meet Beth Heinz, Vice President of Global Business Development at BioAgilytix

Business of Bioanalysis: Forward Looking Vendors as an Ideal Partner

Business of Bioanalysis: Evolving the Use of Bioanalytical Platforms

Biologics Market Growth Demands Quality Science that Can Keep Pace

BioAgilytix Team Q&A: Meet Dr. Isabel Bernges, Project Manager & Study Coordinator at BioAgilytix Europe

Business of Bioanalysis: The Spread of Drug Development Throughout the World

Business of Bioanalysis: The Inherent Risk in Depending on a Single Platform

Key Takeaways from the 14th Annual PEGS Summit

Proof of Concept to Solution: A Unique Approach to Anti-PEG Antibodies Assessment

BioAgilytix Team Q&A: Meet William Hunter, Director of Business Development and Global Key Accounts at BioAgilytix Europe

Business of Bioanalysis: Introducing Technology Improvements During a Study

Evaluation of CAR T-Cell Therapy Toxicities by Measurement of Cytokines During Therapy

FDA Guidance for Industry: Bioanalytical Method Validation, May 2018

BioAgilytix Team Q&A: Meet Florian Sieglitz, Principal Investigator and BPM at BioAgilytix Europe

Evaluating the Immunogenicity of Antibody–drug Conjugates

Key Takeaways from the 12th Workshop on Recent Issues in Bioanalysis (WRIB)

BioAgilytix: Impacting Our Industry, Science, and Patient Health for 10 Years

Immuno-oncology in 2018: Overcoming Challenges to Revolutionize Cancer Treatment

Business of Bioanalysis: Investing in Technology Implementation

Business of Bioanalysis: Forming Partnerships to Justify New Technology Investments

Business of Bioanalysis: Understanding ROI in Platform Selection

BioAgilytix Team Q&A: Meet Jon Rush, Project Manager at BioAgilytix

Strategies for Development and Validation of Neutralizing Antibody Assays Supporting Biosimilars

Determining the Efficacy of Biologics Using Potency Assays Under Good Manufacturing Practice Regulations

Business of Bioanalysis: The Challenges of Software Validation

Clinical relevance of immunogenicity: an interview with Arno Kromminga

CAR T-Cell Therapy: Changing the Way Cancer is Treated

Platform Spotlight: Extending Capacity for Immune Response Monitoring and Cell Line Characterization with BD FACSLyric™

Exploratory biomarker testing: to qualify or validate the assay?

A Dose of Pharma and Biotech News: March 7, 2018

BioAgilytix Team Q&A: Meet Daniel Cohen, Business Development Director, Mid-Atlantic and Asia

Maximizing Drug Tolerance While Maintaining Sensitivity Using Novel Methods

Supporting Biosimilar Assessment: Best Practices for the Development and Validation of Neutralizing Antibody Assays

Strategic Bioanalytical Partnerships for the Win-Win-Win

Preparing and Editing Calibration Curves in Quantitative Ligand Binding Assays: What are the Best Practices?

BioAgilytix Team Q&A: Meet Matt Bray, Scientist and Bioanalytical Project Manager

Evaluating the Immunogenicity of Antibody-Drug Conjugates

Exploratory Biomarker Testing: to Qualify or Validate the Assay?

Closing Diagnostic Gaps by Anti-α-Gal IgE Immune Profiling

The Scientific Topics that Shaped Our 2017

Modern Challenges of Single and Multiplex Biomarker Validation

Recommendations for the Development and Validation of Neutralizing Antibody Assays in Support of Biosimilar Assessment

Calibration Curves in Quantitative Ligand Binding Assays: Recommendations and Best Practices for Preparation, Design, and Editing of Calibration Curves

Immunogenicity Considerations for Antibody–drug Conjugates: A Focus on Neutralizing Antibody Assays

BioAgilytix Team Q&A: Meet Christine Ford, Corporate Compliance Manager

BioAgilytix Team Q&A: Meet Jessica Rohrman, Scientist II and Bioanalytical Project Manager

BioAgilytix Team Q&A: Meet Angela Daniels, QC Specialist IV

Influencers in the Assessment of Immunogenicity Part 2: Immunogenicity of Biosimilars

Business of Bioanalysis: Merger and Acquisition Challenges for CROs

Business of Bioanalysis: Creating Additional Value Through M&A

Business of Bioanalysis: The Importance of Company Culture in CRO Mergers

Business of Bioanalysis: Change in the Pharma Industry Creates Opportunities

Business of Bioanalysis: The Impact of Pharma Mergers on CROs

Webinar on Demand: Challenges of Single and Multiplex Biomarker Validation on ‘Planet Earth’ Versus ‘Planet Biomarkertopia’

How Engaging Bioanalytical Talent Closes Continuity Gaps in Studies

Business of Bioanalysis: The Importance of Soft Skills for Scientists

Business of Bioanalysis: Bioanalytical Opportunities for Diverse Backgrounds

Business of Bioanalysis: How we Develop Scientists Through Functional Project Teams

Business of Bioanalysis: Supporting the Diverse Needs of Our Employees

Why Bioanalytical Technology Strategies Require an Analytical Approach

Business of Bioanalysis: Our Commitment to Employee Recognition

Business of Bioanalysis: How We Identify and Train Quality Scientific Talent

Business of Bioanalysis: When to Bring in New Bioanalytical Technology

Business of Bioanalysis: Investing in Innovative Bioanalytical Technology

Outsourcing Bioanalysis: An Opportunity to Enhance Your Large Molecule Development Strategy

Taking Action to Guide Effective Biosimilar Development

Bioanalysis Zone’s “Ask the Experts” Series on Biosimilars

Managing Diverse Bioanalytical Talent in an Evolving Industry

Platform Spotlight: Analyze Immunology Assays on a Nanoliter Scale with Gyros

Meat allergy associated with galactosyl-α-(1,3)-galactose (α-Gal)-Closing diagnostic gaps by anti-α-Gal IgE immune profiling

Defining Best Practices for Biosimilar Development

Investing in Emerging Bioanalytical Technologies: A Balancing Act

Influencers in the Assessment of Immunogenicity, Part 1: The Basics of Immunology

Novel Circulating Biomarkers and Pathways May Help Predict Type 2 Diabetes More Efficiently

Webinar on Demand: Recent Aspects and Challenges in the Assessment of Immunogenicity

Right the First Time, for the Right Results: CRO Selection is a Critical First Step

A Dose of Pharma and Biotech News: August 9, 2017

Applying Cell-Based Assays, Part 2: Potency Testing for Lot Release Under GMP

Applying Cell-Based Assays, Part 1: Neutralizing Antibody (NAb) Detection

Clinical Impact of Immunogenicity: Lifesaving Drugs Versus the Immune System

Preparing for the Implications of “Brexit” in the Pharmaceutical Industry

Platform Spotlight: ELISA, Still the Most Used Immunoassay Platform to Support Large Molecule Bioanalysis

A Dose of Pharma and Biotech News: June 28, 2017

Supreme Court Decision Creates an Opportunity for Biosimilar Developers

The BioAgilytix Way: Our Unique Approach to Large Molecule Bioanalysis

Leading the Way in Large Molecule Bioanalysis, Our Way

The Evolving Treatment of Lung Cancer: From Combination Chemotherapy to Immune Checkpoint Inhibitors

Outsourcing Clinical Biomarkers: Challenges and Opportunities

Key Takeaways from the 11th Workshop on Recent Issues in Bioanalysis

Considerations to Set ADA Cut Points

The Challenges of Standardizing Commercial Kits for Biomarker Quantification, Part 3: Ensuring the Right-Fit Kit

The Evolving Future of Bioanalytical Outsourcing: What It Means for Our Industry

Cell-Based Assays Keep Biosimilars on Track

ATCC and BioAgilytix: End-to-End Cell-Based Assay Development Services

The Challenges of Standardizing Commercial Kits for Biomarker Quantification, Part 2: Work Planning and Vendor Selection

BioAgilytix Corporate Overview: Scientific Excellence in Large Molecule Bioanalysis

The Challenges of Standardizing Commercial Kits for Biomarker Quantification in Drug Development: Part 1

Interview with Afshin Safavi (Founder & CSO, BioAgilytix) on biomarker analysis in support of preclinical and clinical studies

Novel Gene Therapy Technique Creates a Breakthrough in Sickle Cell Anemia Treatment

Managing unwanted immunogenicity of therapeutic proteins

I Saw the Future and the Future is Biomarkers

BioAgilytix: From Solution Provider to Problem Solver

BioAgilytix Scientific Focus: Biomarkers

Plasma Biomarkers: the Key to Early Alzheimer’s Diagnoses

Mass Biologic Patent Expiration Creates a Race for Biosimilar Innovation

Webinar Recording: Considerations for Evaluation of Accuracy, Parallelism and Reagent Lot to Lot Variability in Single and Multiplex Biomarker Ligand-Binding Assays

Assay Design for Immunogenicity Testing: Cell-Based or Ligand Binding?

Immuno-oncology: Advancing Innovative Therapeutic Options for Treating Human Cancers

Meeting the rigorous demands of biosimilar pharmacokinetics

2016 White Paper on recent issues in bioanalysis: focus on biomarker assay validation (BAV): (Part 3 – LBA, biomarkers and immunogenicity)

Biomarkers and Immunogenicity in the Spotlight at the 2016 10th Workshop on Recent Issues in Bioanalysis

AAPS Webinar Recording: Bioanalytical Methods in Support of Biosimilar Drug Development

BioAgilytix Scientific Focus: Cell-Based Assays

What a Year! Looking Back at What’s Driving Us Forward in 2017

Humoral Immune Response to AAV

Large Molecule Sample Analysis for a Large Number of Samples: Why Veteran Expertise is Critical to Success

Changing the Dialogue on CRO Communication: Responsiveness for Better Bioanalytical Results

In Bioanalysis, Timing is Everything: Can Your CRO Keep Up with Your Innovation Demands?

Where Expertise and Quality Converge: For CROs, One Isn’t Optimized without the Other

BioAgilytix Scientific Focus: Immunogenicity

BioAgilytix Scientific Focus: Pharmacokinetics (PK)

What You Won’t Learn in School: Real-World Advice to Early Career Scientists

Crystal City VI Workshop Report: A Positive Step in Furthering the Dialogue on Biomarker Assay Challenges

New Paths for Biomarker Development: Clearing the Way for Faster Innovation

BioAgilytix Innovates and Grows in the ‘National Innovation Triangle’

The Importance of Parallelism in Biomarker Assay Development

Toxicology and Agatha Christie: An Arresting Pairing

‘It’s All Relative’: The Concept of Accuracy in Biomarker Analysis

Overcoming the Challenges of Critical Reagent and Kit Lot-to-Lot Variability in Support of Clinical Trial Biomarker Studies

Guidance for Industry (Draft Guidance): Assay Development and Validation for Immunogenicity Testing of Therapeutic Protein Products, April 2016

EMA Guideline on Immunogenicity assessment of biotechnology-derived therapeutic proteins, September 2015

Guidance for Industry: Quality Considerations in Demonstrating Biosimilarity of a Therapeutic Protein Product to a Reference Product, April 2015

Guidance for Industry: Scientific Considerations in Demonstrating Biosimilarity to a Reference Product, April 2015

EMA Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance, December 2014

What’s Your System for Cell-Based Assay Method Selection?: Factors in Assessing the Most Advantageous Model for Your Needs

Establishment of the first WHO Erythropoietin antibody reference panel: Report of an international collaborative study

Serum pharmacokinetics and cerebrospinal fluid concentration analysis of the new IgG4 monoclonal antibody GNbAC1 to treat multiple sclerosis: A Phase 1 study

Not the Same, But Not Too Different: Demonstrating ‘Biosimilarity’ for Biosimilars with Comparative PK and Immunogenicity Assays

Quality is More Than Good Laboratory Practice (GLP): Perspectives From an Advanced Quality Laboratory

B cell epitopes on infliximab identified by oligopeptide microarray with unprocessed patient sera

Taking the Stage on Bioanalytical Topics – Looking Back & Looking Ahead

Taking the Stage on Bioanalytical Topics – Looking Back & Looking Ahead

How to win client trust as a CRO

Running a successful CRO

How to set up a successful CRO by surrounding yourself with the right team members

Starting a CRO on personal credit

Virtual Podium: Biomarkers for Heart Disease in African American Women with Lupus

Virtual Podium: Biomarkers and Alzheimer’s Disease

Virtual Podium: Seeking the Biomarkers of Alzheimer’s Disease – On Our Mind

Virtual Podium: Biomarkers for Lupus Diagnosis and Disease Activity

The quintessence of immunogenicity reporting for biotherapeutics

Preclinical and early clinical development of GNbAC1, a humanized IgG4 monoclonal antibody targeting endogenous retroviral MSRV-Env protein

Virtual Podium: How is Your Assay Performing? Biomarker Validation Best-Practices

Virtual Podium: An Analytical Approach to Platform Comparison

Virtual Podium: The Present and Future of Biosimilars: Opportunity Abounds

Virtual Podium: What’s Your System for Cell-Based Assay Method Selection

Platform Comparisons Guide

2014 White Paper on recent issues in bioanalysis: a full immersion in bioanalysis (Part 3 – LBA and immunogenicity)

7th GCC Insights: incurred samples use; fit-for-purpose validation, solution stability, electronic laboratory notebook and hyperlipidemic matrix testing

Chapter 7: Case studies: challenges of developing and validating PK and immunogenicity assays to support pre-clinical and clinical comparability studies for biosimilars

Parallelism and Matrix Interference: The Importance of Nomenclature (Part 1)

Systematic Verification of Bioanalytical Similarity Between a Biosimilar and a Reference Biotherapeutic: Committee Recommendations for the Development and Validation of a Single Ligand-Binding Assay to Support Pharmacokinetic Assessments

Bioanalytical Buyer’s Guide

Recommendations on incurred sample stability (ISS) by GCC

Growing Clinical Biomarker Assays

Potential induction of anti-PEG antibodies and complement activation toward PEGylated therapeutics

Assessment and Reporting of the Clinical Immunogenicity of Therapeutic Proteins and Peptides-Harmonized Terminology and Tactical Recommendations

8th GCC: consolidated feedback to US FDA on the 2013 draft FDA guidance on bioanalytical method validation

Recommendations on bioanalytical method stability implications of co-administered and co-formulated drugs by Global CRO Council for Bioanalysis (GCC)

Recent Issues in Bioanalysis and Alignment of Multiple Guidelines

Assessment and reporting of the clinical immunogenicity of therapeutic proteins and peptides-harmonized terminology and tactical recommendations

Multidisciplinary approach to evaluating immunogenicity of biosimilars: lessons learnt and open questions based on 10 years’ experience of the European Union regulatory pathway

Webinar: Assay and Kit Lot Bridging Considerations for Single and Multiplex Biomarker Analysis

Development and validation of an alpha fetoprotein immunoassay using Gyros technology

Implementation of a universal analytical method in early-stage development of human antibody therapeutics

Validation of a Gyrolab™ assay for quantification of rituximab in human serum

Application of miniaturized immunoassays to discovery pharmacokinetic bioanalysis

Application of miniaturized immunoassays to discovery pharmacokinetic bioanalysis

2013 White Paper on recent issues in bioanalysis: ‘hybrid’–the best of LBA and LCMS

Measures of biosimilarity in monoclonal antibodies in oncology: the case of bevacizumab

Immune responses to AAV vectors: overcoming barriers to successful gene therapy

Inhibition of oncogenic Pim-3 kinase modulates transformed growth and chemosensitizes pancreatic cancer cells to gemcitabine

Analytical and bioanalytical assay challenges to support comparability studies for biosimilar drug development

Immunogenicity of anti-TNF biologic therapies for rheumatoid arthritis

FDA Guidance for Industry: Immuogenicity Assessment for Therapeutic Protein Products, February 2013

In vitro and in vivo studies of IgG-derived Treg epitopes (Tregitopes): a promising new tool for tolerance induction and treatment of autoimmunity

Biosimilars: what clinicians should know

Setting the stage for biosimilar monoclonal antibodies

EMA Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance, November 2012

Conference report: 6th GCC focus on LBA: critical reagents, positive controls and reference standards; specificity for endogenous compounds; biomarkers; biosimilars

Recommendations on biomarker bioanalytical method validation by GCC

Virtual Podium: Western Blot Protocol

Recommendations on bioanalytical method stability implications of co-administered and co-formulated drugs by Global CRO Council for Bioanalysis (GCC)

Challenges of developing and validating immunogenicity assays to support comparability studies for biosimilar drug development

2012 white paper on recent issues in bioanalysis and alignment of multiple guidelines

6th GCC – “Focus on LBA”: critical reagents, positive controls and reference standards; specificity for endogenous compounds; biomarkers; biosimilars

Lot Bridging Considerations for Immunoassay Kits in Biomarker Studies

Ligand-Binding Assays in the 21st Century Laboratory: Recommendations for an Automated Data Interchange Process

FDA Guidance for Industry: Scientific Considerations in Demonstrating Biosimilarity to a Reference Product, February 2012

EMA Reflection paper for laboratories that perform the analysis or evaluation of clinical trial samples, EMA/INS/GCP/532137/2010, February 2012

Ligand Binding Assays in the 21st Century Laboratory: Recommendations for Characterization and Supply of Critical Reagents

Ligand Binding Assays in the 21st Century Laboratory: Automation

Ligand Binding Assays in the 21st Century Laboratory: Platforms

Recommendations on the Interpretation of the new EMA Guideline on Bioanalytical Method Validation by Global CRO Council for Bioanalysis

Evaluation of the MSD Multiplex Electrochemiluminescent Immunoassay for the Determination of Cardiac Toxicity Biomarkers in Rat Serum

Evaluation of Multiplex Electrochemiluminescent Immunoassays for Quantitative Determination of Kidney Injury Biomarkers in Rat Urine

Recommendations and requirements for the design of bioanalytical testing used in comparability studies for biosimilar drug development

EMA Guideline on the investigation of bioequivalence, CPMP/EWP/QWP/1401/98, August 2010

EMA Concept paper on immunogenicity assessment of monoclonal antibodies intended for in vivo clinical use, June 2009

EMA Concept paper/recommendation on the need for a (CHMP) guideline onthe validation of bioanalytical methods, March 2009

EMA Guideline on immunogenicity assessment of biotechnology-derived therapeutic proteins, December 2007

EMA Guideline on non-clinical and clinical development of similar biological medicinal products containing recominant EPOs, October 2005

EMA ICH Topic E 6 (R1) Guideline for Good Clinical Practice, CPMP/ICH/135/95, July 2002

FDA Guideline on validation of bioanalytical methods, May 2001

ICH Q2B Guideline Validation of Analytical Procedures Methodology

ICH S6 Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals