Method validation is a process that is used to confirm whether the analytical procedure used for drug analysis is suitable for its intended use. Method qualification vs validation is crucial to understanding the differences between initial assessments and full-scale validation. ICH Analytical method validation, following ICH method validation guidelines, is the key to judging the quality, consistency, and reliability of sample analysis data. For most healthcare regulators, including the FDA, method qualification vs validation plays a critical role in preclinical and clinical studies, with method validation is a mandatory step in preclinical and For most healthcare regulators, including the FDA, method validation is a mandatory step in preclinical and clinical studies for pharmacokinetic and toxicokinetic evaluation to fulfill specific performance criteria. Additionally, compliance with ICH guidelines for method validation ensures adherence to global regulatory standards. Our approach also aligns with the bioanalytical method validation guidance for industry, ensuring robust methods that meet both regulatory and industry expectations.
Bioanalytical Method validation takes place in the following cases:
When it comes to test method validation, it’s important to follow standard guidelines like FDA bioanalytical method validation guidance for industry and ICH analytical method validation. If you have your own protocols, that’s great, if not, you need to develop a method validation plan. A good method validation process will test several ICH validation parameters such as calibration range, linearity, and accuracy and precision, robustness, specificity, and process stability of the analyte. Good Documentation Practice (GDP) should be in place to ensure that a full description of the method is captured in enough details to be followed by an independent analyst later.
Connect With Us For A Reference Call With Them!
NorthEast BioLab is by far the most responsive and thorough bioanalysis lab services CRO.
We partnered on several programs and found NorthEast BioLab responsive, collaborative, and reliable.
We trust NorthEast BioLab to design and execute the most streamlined and impactful bioanalytical projects.
We found their integrity as refreshing as readiness to provide creative scientific input and high-quality data.
We have worked with NorthEast BioLab for over ten years given their commitment to highest quality bioanalytical data.
NorthEast BioLab tremendously supported us in reproducing our critical lab discoveries for drug metabolism.
NorthEast BioLab always exceeds expectations on bioanalytical assay development, validation, and sample analysis.
NorthEast BioLab truly goes that extra mile, and we hope to continue enjoying seminal interactions with them.
NorthEast BioLab presents a science-based, hands-on, no-frills approach on the latest bioanalytical platforms.
We are thrilled to complete our bioanalytical studies with their top quality and incredibly responsive team.
We worked closely to implement the most efficient and cost-effective bioanalytical assay for our PK Studies.
Our projects with NorthEast BioLab include successful method development, validation, stability studies during Clinical Phase I – IV studies.
NorthEast BioLab provides critical insight, and are compliant with regulatory standards and industry best practices. We highly recommend them and look forward to working together again.
Our latest successful study was a pivotal bioequivalence study, where samples from a cross-over study with about 100 volunteers needed swift analysis.
This study, same as all other bioanalytical studies with NorthEast BioLab, was completed with top quality and reporting standard with incredible responsiveness.
As a small company, our vendors are key members of our project teams. The scientists at NorthEast BioLab are technical experts, who produce high-quality data, on-time, and on-budget.
We offer a comprehensive suite of bioanalytical method development and validation services to meet your research and regulatory needs.
We deliver precise pharmacokinetic analysis to assess drug absorption, distribution, metabolism, and excretion, vital for understanding pharmacological profiles.
Our assays are designed to accurately assess immunogenicity by detecting antidrug antibodies and neutralizing antibodies in clinical samples, essential for biopharmaceutical evaluations.
Utilizing highly sensitive and validated platforms, we quantify cytokines and biomarkers, offering insights into immune response, disease progression, and therapeutic outcomes.
Our cell-based assays ensure the reproducibility of drug screening, potency testing, and cellular response studies, providing crucial data for biologics development.
We ensure that all bioanalytical methods are fully validated per regulatory guidelines, offering reproducible and compliant results for both preclinical and clinical studies.
We specialize in LC-MS/MS for small molecule analysis, ensuring high sensitivity and specificity, making it ideal for pharmacokinetic and drug metabolism studies.
We develop multiplexed biomarker assays using Meso Scale Discovery technology, offering higher sensitivity, precision, and throughput than traditional methods.
ELISA development and validation services are customized to optimize sensitivity and specificity for protein and antibody detection.
Our qPCR and ddPCR assay expertise enables precise quantification of nucleic acids, supporting studies in gene expression and genetic variation.
We provide advanced flow cytometry services, allowing for multi-parameter analysis of cell populations, contributing to in-depth immunological and cellular research.
With our expertise in traditional and in-cell Western blotting, we offer reliable quantification and detection of proteins, vital for understanding molecular biology and protein expression.
Our method development and validation services adhere to stringent regulatory guidelines, ensuring the highest level of precision, reproducibility, and compliance. This supports your drug development and research projects by delivering reliable and timely results
Bioanalytical Method Validation Services by NorthEast BioLab
NorthEast BioLab test method validation services are extensive and adapt to the different phases of your drug development journey. Our method validation services include but are not limited to:
Full Validation of Newly Developed Methods
We are adept at validation of newly developed methods. This entails completion of full three-day validation as per regulatory guidance (FDA, ICH) on bioanalytical method validation. All experiments for the complete validation are performed, such as determination of method specificity, matrix effect and matrix suppression, extraction recovery, and carryover, etc. Analyte stability in the biological matrix is determined during short-term bench top, autosampler, and freeze-thaw stages. Additionally, we ensure compliance with ICH method validation requirements, ensuring that all processes align with global regulatory standards. Our validation process is meticulously designed to meet ICH analytical method validation criteria, reinforcing our commitment to excellence. Our approach also adheres to the bioanalytical method validation guidance for industry, ensuring comprehensive and industry-compliant validation practices.
Given that drug development is an enormously resource-intensive process, finding the right Contract Research Organization can help you optimize costs and save time. At NorthEast BioLab, we have over 15 years of experience in analytical method development, method qualification vs validation, and transfer. We ensure that our processes align with ICH method validation guidelines, providing globally recognized compliance for your projects. We also rigorously adhere to ICH validation parameters, ensuring that every aspect of our validation meets the highest standards. We make sure that we accomplish our shared goals while pursuing an accelerated timeline and cost optimization.
For method validation, we offer a whole range of stringency levels so that the client can choose what they need. We generate an extremely comprehensive validation report that details the method being validated, as well as its outcomes. We also ensure that we report on the protocol used, calculations made, procedures followed, and equipment used, while distinguishing between method qualification vs validation to ensure clarity in the process. Additionally, our approach aligns with ICH analytical method validation standards to meet industry requirements and expectations.
We understand that collaboration lies at the heart of this process and ensure proper communication between our clients and our front-line lab analysts and managers. We also believe in integrity and transparency and keep our clients in the loop about all research developments. Compliance with ICH guidelines for method validation is integral to our approach, ensuring that our methods meet global standards. Additionally, we adhere to bioanalytical method validation guidance for industry, ensuring that all practices are aligned with both regulatory and industry expectations. We bring together our core strengths, operational excellence, regulatory expertise, and scientific experience to make sure that your drug development process- from drug discovery to clinical trials- flows seamlessly.
Bioanalysis is an essential tool in drug discovery and development for determining the concentration of drugs and their metabolites as well as various pharmacodynamics biomarkers in biological fluids. In these analyses, scientists use developed an….
The developed assay must be specific for the analyte(s) and internal standard in the blank matrix. At least six independent matrix blanks must be analyzed to show that no interferences are arising from different lots of plasma. Assay qualification ensures that the method is capable of consistently identifying and quantifying the analyte(s) in different sample matrices.
The degree to which the signal is suppressed by the extracted components of the matrix is assessed by injecting solutions of the analyte prepared in reconstituted blank matrix extracts and comparing the signal to the analyte prepared in the mobile phase or reconstitution solution. Values are reported as percent suppression. In some instances, signal enhancement is observed.
The ability of the assay to accurately and reproducibly quantitate the analyte(s) in different lots of the matrix is assessed by spiking six independent lots to a concentration equivalent to the QC_Low concentration. Assay qualification is performed to ensure the method is fit for its intended purpose before full validation.
The inter-day accuracy and precision should be calculated using the data from three one-day validation runs. Precision is based on the percent coefficient of variation (%CV) observed by the mean of the QC samples at each QC concentration level.
Stability testing should include process stability, as well as short term and long-term stability of analytes in solution and in the matrix.
Ligand Binding Assays (LBAs) are critical analytical techniques used to measure interactions between ligands, such as drugs or hormones, and their specific targets, including receptors or proteins. These assays are pivotal in drug development and therapeutic monitoring, allowing for the assessment of drug concentrations, biological activity, and the efficacy and safety of new therapeutics. The FDA document details various types of LBAs, including immunoassays, radioimmunoassays, enzyme-linked immunosorbent assays, and fluorescence-based assays. It also highlights the importance of validating these assays to ensure accuracy, precision, and regulatory compliance, emphasizing rigorous standards for assay design and performance to support credible results in regulatory submissions.
Batch run size depends on a variety of factors. Consideration during LC-MS analysis includes autosampler stability, run time, column stability, MS stability, etc. Here, the batch size is determined by repeat injection of blanks with QCs at regular intervals during a validation run.
High and low concentrations of QCs should be used to prepare 6 replicates with lipemic plasma (in mg/dL of lipids). Similarly, 6 replicate samples with hemolytic plasma (based on mg/dL of heme) should be analyzed.
The lower limit of quantitation (LLOQ) indicates the lowest concentration of study samples that can be quantitated with acceptable accuracy. The LLOQ is the lowest calibration standard used to generate a calibration curve.
% Stock Standard = spiking amount (ml) / [matrix amount (ml) + spiking amount (ml) *100
Whenever possible, the method validation should be done in the matrices for which the assay is intended to be used. If unavailable, then evidence must be provided to demonstrate that a substitute is acceptable.
Reference standards used in the preparation of calibration and Quality Control Samples must have a Certificate of Analysis (CoA) indicating the purity and expiration date. A CoA is not required for the internal standard, but the material must be checked for impurities that may interfere with the analyte(s).
Answers to additional Method Validation questions popular among our potential clients.
Qualification: Ensures method suitability before validation.
Validation: Confirms method reliability through detailed experiments.
Includes testing Reference Standards, Calibration Curve, QCs, and various method attributes.
Three or six runs over multiple days are needed to assess the accuracy and precision of CCs and LBAs.
Bench-Top, Freeze-Thaw Cycles, Short-Term ULT Stability.
A Full report in PDF format and on-site/archived documentation.
Partial validation evaluates previously validated methods with recommended modifications. It can range from a single intra-assay precision check to a full validation. Raw data from partial validation is retained and may be requested during inspections.
Yes, we offer methods for non-proprietary compounds that have already been validated. We ensure the approach is suitable for the current drug development stage, which helps speed up development and optimize resources.
Re-validation may be required when analyzing new compounds, changing the sample matrix, or updating the method according to new regulatory guidelines.
