Bioequivalence Studies Monitoring

India is a favorite destination for foreign Sponsors to conduct Bioequivalence Studies and Clinical Trials due to the regulatory compliant system (BA/BE Sites are Inspected by almost all International Regulatory Authority), cost and speed of execution. The sponsor needs to pay multiple visits for identification and conduct of BE study of interest of their molecules. Many times the response from different CROs is quite varied in terms of BE study design, sample size, cost etc. The verification and monitoring of the entire process from the selection of BE sites till finalization of the report is very important for a successful BE study submission to the regulatory authority. Auriga Research has more than 15 years of experience and managed more than 250 BE studies for design, conduct and analysis. 

Our expertise in this field can help in selection of the right CRO partner for their product of interest for BE study.  Further Auriga has a complete electronic trial management system which includes Clinical Trials Management System (CTMS), Electronic Trial Master File eTMF), Remote Source Data Verification (rSDV), Quality Management System (QMS) and Training Management System (TMS). The remote qualification and monitoring activities can be conducted by providing access to electronic tools and sponsors can participate online from their workplace.

There are BE studies which are very challenging and cost intensive like HVDs, NTTIs, Patient Studies, Biological Products etc. The proper selection of CRO and continuous monitoring is very essential for a positive outcome which is acceptable to regulatory submission.

 

Below are the activities where Auriga can assist sponsors. 

  1. BA/BE Studies Design Inputs
  • Literature review from published studies
  • Product Specific Regulatory Guidance
  • RLD identification and Sourcing
  • Study design – Crossover, Parallel, Replicate, Steady state
  • Study State – Fasting/Fed
  • Sample Size Calculation
  • Study Samples time point
  • Review of In-vitro data for BE confirmation
  • Protocol Development  and Review
  • Regulatory Application of BA/BE Study Protocol for old and new drug in CT-05, CT-16 and Form-12
  • Analyte and Bioanalytical Method
  • Review of PK and Statistical Analysis
  • CSR preparation and review

 

  1. BE Study Monitoring
    • BE Center Selection and Audit
    • Communication with BE Center
    • Monitoring of BE study at different stage
    • Source Data Verification
    • In process audit 

 

  1. PK Analysis by Phoenix WinNonLin: 

Auriga Research offers Pharmacokinetic Analysis for bioavailability/bioequivalence study and PK analysis for Preclinical & Clinical Development stage.

Below are the study analysis for different design of PK Studies

  • Two Way Crossover Study Design
  • Parallel Study Design
  • Partial Replicate Study Design
  • Fully Replicate Study Design
  • Partial/Fully Replicate Study Design for HVDs
  • Fully replicate Study Design for NTI Drugs
  • PK Modelling and Simulation

 

  1. Setting up new BE facility and readiness for Inspection
  • Study Center Layout
  • Budgeting
  • Instruments list and qualification
  • Study Team Structure
  • Setting up SOPs
  • Study Center Application to Regulatory
  • Bioanalytical Setup
  • Readiness for Regulatory Inspection
  1. RLD/Innovator Sourcing

 

Bioequivalence Product Specific Guidance:

For designing a bioequivalence study protocol for any drug product we need some important information and try to compile as a synopsis of study and it became our basis for writing complete protocol. We have prepared BE synopsis of many products and included key information as mentioned below after through literature search from the international publication and made product specific readymade synopsis which can be helpful in making the final protocol. 

  • RLD/Innovator of drug product
  • Study Design – Crossover/ Parallel/Replicate
  • Study Population – Male/Female/Both
  • Dosing Administration – Fasting/Fed
  • Regulatory approval status in India, Europe and US
  • Published references on bioavailability and bioequivalence of drug product
  • Sample Size for pivotal study
  • Pharmacokinetic Parameters
  • Sampling time points and Washout Period
  • Safety Precautions if any
  • Published references on Bioanalytical Methodology
  • Analyte and metabolite to be measured in the biological matrix
  • Bioequivalence Criteria 

 

You can provide the details of your product of interest for BE study to share BE study synopsis comprising all above detail.

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Once you fill out this form, you will:

1. Get an email or phone from our team to understand your exact requirement.
2. After that, a quotation catering to your requirement will be sent to your mail.
3. Once you approve the quotation, you can send us the sample for testing and we would provide you with the test report.

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