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                                                            • Home
                                                            • Dose Formulation Analysis

                                                            GLP Method Validation And Dose Formulation Analysis For Your Preclinical And Clinical Studies!

                                                            • Reliable Dose Formulation Concentration, Homogeneity, And Stability Testing
                                                            • FDA Audited Lab Offering Dose Formulation Method Validation For In-Vivo Toxicology, AMES, hErg, Or Other Formulation Studies
                                                            • High Sensitivity Bioanalysis Using LC With UV/Vis Or Mass Spec
                                                            • Accurate Stability Assessment Under Storage And Lab Conditions

                                                            Regulated And Inspected By:

                                                            Good Laboratory Practice for Nonclinical Laboratory Studies | NorthEast BioLab Food and Drug Administration (FDA | NorthEast BioLab Clinical Laboratory Improvement Amendments | NorthEast BioLab International Orgaization for Standardization |NorthEast BioLab

                                                            Provide Your Bioanalysis Study Details

                                                            We Will Respond Within 1 Business Day

                                                            Dose Formulation | NorthEast BioLab
                                                            Click below for answers to your Dose Formulation Analysis questions -
                                                            • What is Dose Formulation Analysis?
                                                              What is Dose Formulation
                                                              Analysis?
                                                            • Which Dose Formulation Analysis Services do we Offer?
                                                              Which Dose Formulation Analysis Services do we Offer?
                                                            • Why Choose us for your Dose Formulation Analysis?
                                                              Why Choose us for your Dose Formulation Analysis?
                                                            • When is Dose Formulation Analysis performed during Drug Development?
                                                              When is Dose Formulation Analysis performed during Drug Development?

                                                            Ask Us About Your Study

                                                            GLP/Non-GLP Dose Formulation Analysis during Toxicology Studies for Drug Development and Regulatory Submission

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                                                            What is Dose Formulation Analysis?

                                                            Dose Formulation Analysis: Testing Concentration, Specificity, Homogeneity, and Stability

                                                            Dose formulation analysis is performed to assess test article concentration, formulation homogeneity, and formulation stability. Currently, there is limited regulatory guidance on preclinical method validation for formulation sample analysis. However, several stipulations are necessary for drug product/formulation testing following dose formulation analysis GLP regulations, and these methods can be validated following the FDA’s bioanalytical guidance.

                                                            The AAPS whitepaper “NonClinical Dose Formulation Analysis Method Validation and Sample Analysis” (2010) refers to the formulation analysis practices required for GLP toxicology studies. The primary differences in bioanalytical and drug product validations typically involve acceptance and stability criteria, since formulations usually show less analytical variability and are stored under differing conditions.

                                                            Dose formulation analysis for regulated preclinical and clinical studies is conducted in compliance with one or more of the following: US Food and Drug Administration (FDA) Good Laboratory Practice (GLP) regulations as per 21 CFR part 58, the European Medicines Association (EMA) Principles of Good Laboratory Practice, the Japanese Ministry of Health, Labor and Welfare (MHLW) Number 21, and the FDA Guidance for Industry: Bioanalytical Method Validation.

                                                            Sponsors Love Our Bioanalytical Laboratory Services For Top Quality And Industry Leading Turnaround

                                                            Connect With Us For A Reference Call With Them!

                                                            User Vector
                                                            VP, Bioanalytical Development

                                                            “NorthEast BioLab is the most responsive and thorough bioanalysis lab services CRO.”

                                                            User Vector
                                                            VP, Biomarker Development 

                                                            NorthEast BioLab is a responsive, collaborative, and reliable partner

                                                            User Vector
                                                            Executive Director, Pharmacokinetics

                                                            We trust NorthEast BioLab to design and execute streamlined, impactful bioanalytical projects

                                                            User Vector
                                                            President & CSO, Biotech

                                                            We found their integrity as refreshing as readiness to provide creative scientific input and high-quality data

                                                            User Vector
                                                            Sr. Associate Dir., Clinical Trials

                                                            We have worked with NorthEast BioLab for over ten years given their commitment to highest quality bioanalytical data.

                                                            User Vector
                                                            Co-Founder, Biotech & University PI

                                                            NorthEast BioLab tremendously supported us in reproducing our critical lab discoveries for drug metabolism

                                                            User Vector
                                                            VP, PK PD Analysis

                                                            NorthEast BioLab always exceeds expectations on bioanalytical assay development, validation, and sample analysis.

                                                            User Vector
                                                            Head, Bioanalytical Development

                                                            “NorthEast BioLab goes the extra mile. We look forward to more meaningful collaborations.”

                                                            User Vector
                                                            Sr. Dir., Bioanalytical Development & QC

                                                            NorthEast BioLab offers a science-based, hands-on approach to the latest bioanalytical platforms

                                                            User Vector
                                                            SVP Quality & Compliance, Biotech

                                                            We are thrilled to complete our bioanalytical studies with their top quality and incredibly responsive team.

                                                            User Vector
                                                            Director, PK

                                                            We worked closely to implement the most efficient and cost-effective bioanalytical assay for our PK Studies.

                                                            User Vector
                                                            VP, Head of Clinical Operations

                                                            Our projects with NorthEast BioLab include successful method development, validation, stability studies during Clinical Phase I – IV studies.

                                                            User Vector
                                                            Executive Director, Drug Research

                                                            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.

                                                            User Vector
                                                            Dir., Bioequivalence Testing

                                                            Our latest successful study was a pivotal bioequivalence study, where samples from a cross-over study with about 100 volunteers needed swift analysis.

                                                            User Vector
                                                            Head, PK

                                                            This study, same as all other bioanalytical studies, was completed with top quality and reporting standard with incredible responsiveness.

                                                            User Vector
                                                            VP, Development Operations

                                                            NorthEast BioLab’s scientists deliver high-quality data on time and within budget

                                                            Tackle Your Dose Formulation Analysis With Our Veteran Team Now!

                                                            SPEAK TO OUR SCIENTISTS

                                                            Which Dose Formulation Analysis Services do we Offer?

                                                            Dose Formulation Analysis Services by NorthEast BioLab

                                                            NorthEast BioLab promptly performs GLP formulation method validation on platforms such as LC-MS/MS, HPLC/FL, HPLC/UV, or ELISA for analysis of drug content in liquid formulations. Tested formulations may include one for the general toxicology safety evaluation studies; one used in the in vitro genetic toxicology assays (GeneTox/AMES); and one for use in the human ether-a-go-go (hERG) assay. During method validation, we evaluate the test article concentration as well as homogeneity and stability of the formulation to cover the expected conditions during preparation, storage, dosing, and shipment. Furthermore, we identify any issues with solubility or stability before the start of toxicology studies and verify ligand-binding functional activity for antibody biologics. Our approach to GLP formulation method validation allows quick cross-validation of our assays for new formulation matrices, salt forms, and concentration ranges, lending the versatility required to keep up with your projects.

                                                            Dose Formulation Analysis | NorthEast BioLab

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                                                            • Good Laboratory Practice for Nonclinical Laboratory Studies | NorthEast BioLab
                                                            • Food and Drug Administration (FDA | NorthEast BioLab
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                                                            • United States Drug Enforcement Administration | NorthEast BioLab
                                                            • Department of Consumer Protection | NorthEast BioLab

                                                            Don’t Wait, Start Your Dose Formulation Analysis Service Today!

                                                            SPEAK TO OUR SCIENTISTS
                                                            Dose Formulation Analysis | NorthEast BioLab

                                                            Why Choose us for your Dose Formulation Analysis?

                                                            Prompt Dose Formulation Analysis to Optimize your Drug and Vehicle

                                                            Dose formulation analysis requires both an iterative approach and in-depth expertise. NorthEast BioLab is the right partner to bring your novel and effective formulations to the market, given our nuanced understanding of drug safety and efficacy. Our team of veteran scientists can help establish your dose formulation analysis (GLP or drug discovery) based on our 20+ years of experience with method development and validation. Together, we would develop robust analytical methods to support your formulation analysis studies for achieving your desired concentration, specificity, homogeneity, and stability parameters. We promise high quality and take full responsibility for your studies with us, including compliance with regulations mandated by agencies such as FDA, EMA, and ICH.

                                                            The Basics of Bioanalysis

                                                            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….

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                                                            Basics Of Bioanalysis | NorthEast BioLab
                                                            Drug Discovery Formulation Sample Analysis | NorthEast BioLab

                                                            When is Dose Formulation Analysis performed during Drug Development?

                                                            Dose Formulation Analysis: From Drug Discovery and Preclinical to Clinical Phases

                                                            Drug Discovery Formulation Sample Analysis

                                                            Dose formulation analysis during early drug discovery determines the correct dosage for proper concentration, homogeneity, and stability of the test article in any vehicle. Formulation analysis of several vehicles during exploratory pharmacokinetics or disease model efficacy testing could help pick the best alternative for a novel compound or class of compounds. Similarly, salt forms or prodrugs of the potential drug can be evaluated to decide whether these forms yield better solubility for improved in-vivo absorption.

                                                            In early discovery testing, the formulation analysis needs to only sufficiently demonstrate therapeutic delivery for supporting proof-of-concept and lead target identification. The robustness of these formulations for accuracy, homogeneity, repeatability, and stability, is not typically considered until regulated preclinical toxicology data gets generated.

                                                            GLP Formulation Method Validation

                                                            Regulated formulation analysis studies during preclinical and clinical development require method validation. GLP formulation method validation experiments span the anticipated dose concentration range and include testing for accuracy, precision, specificity, curve linearity, and analyte stability. Generally, homogeneity in formulation analysis is tested for the first test batch low and high dosage form concentrations and if there is a significant change in batch size. Homogeneity is usually tested by assessing replicate samples from the bottom, middle, and top strata of the dose form preparation vessel. Stability in formulation analysis is tested by collecting samples from the lowest and highest dosage concentrations at a minimum. Replicate samples for stability are stored at the conditions for in-life study and evaluated for the time from preparation to final dose.

                                                            Preclinical (or nonclinical) dose formulation analysis is required in all regulated studies to assess drug safety. The primary purpose of preclinical toxicology studies is to establish safety margins for clinical studies. Formulation sample analysis following GLP formulation method validation in regulated studies, in turn, verifies test article concentrations in the formulations for preclinical toxicology studies.

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                                                            Expertise

                                                            Expertise

                                                            • Mass Spectrometry (LC-MS)
                                                            • Meso Scale Discovery Assay
                                                            • ELISA Assay
                                                            • Flow Cytometry
                                                            • qPCR Analysis, ddPCR Assay
                                                            • Western Blot, In Cell Western

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                                                            • ADA Assay, Neutralizing Antibody Assay
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