BIOEQUIVALENCE STUDIES

BIOEQUIVALENCE STUDIES

Our bioanalysis experts are experienced in the comprehensive management of bioequivalence studies, offering end-to-end service from IMPD review to final reporting. We work in alliance with reputed European clinical and preclinical centers following EMA and FDA guidelines. High-quality standards, narrow timelines and competitive prices are key elements for our delivery. We are fully coordinated with our alliance partners to provide One Stop Shop services for bioequivalence studies in the following areas:

Bioequivalence - clinical studies

BIOEQUIVALENCE STUDIES MANAGEMENT

BIOEQUIVALENCE STUDIES REPORTING

  • Protocol writing
  • Submission to Ethics Committee and Regulators
  • Insurance contracting
  • Clinical center management and monitoring
  • Bioequivalence studies execution
  • Plasma sample shipment and storage
  • Phoenix WinNonlin® data analysis
  • Pharmacokinetic report
  • Final clinical report
  • Specific reports to Authorities requests

BIOANALYSIS FOR BIOEQUIVALENCE STUDIES

SUPPORT ACTIVITIES TO BIOEQUIVALENCE STUDIES

  • LC-MS/MS and HRMS for small molecules
  • ICP-MS for metal/organometallic analysis
  • ELISA, ECLA and RIA for small peptides
  • IMPD writing or review
  • Analytical testing for stability studies
  • Comparative dissolution profiles
  • Importation of reference and test products
  • Batch testing and batch release
  • Physical-Chemical analysis of administration solutions/formulations

Our experts for bioequivalence studies can transfer existing bioanalytical methods and have a long list of validated methods offering the Clients the opportunity of directly analyzing their samples thereby saving time and money. If one is not available, we can develop and validate the method free of charge in a timely manner.

WE OFFER AN EXTENSIVE LIST OF VALIDATED METHODS FOR BIOANALYSIS AND CMC

In case you are not able to find the bioanalytical or CMC method you need, please contact us. Our experts will check if we can develop the method for you or add it to our validated method list.

Related Services to Bioequivalence Studies

Bioanalysis of Small Molecules

Development and validation of analytical methods for analysis of biological samples delivered mainly from pre-clinical and clinical studies.

Pharmacokinetic Evaluation

Pharmacokinetic calculations and statistics of bioanalytical data from preclinical and clinical studies with Phoenix WinNonlin®.

Bioanalysis of Biologics and Biosimilars

Method development and validation and sample measurement of biologics and biosimilars.

Nucleic Acids Analysis

Quantification of nucleic acids as therapeutics, biomarkers or similar with standardized and reproducible methods according to GLP.

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