Bioavailability-Bioequivalence Studies

We are leaders of design, execution, and analysis of Bioavailability-bioequivalence and pharmacokinetic studies in Argentina

Studies

• Bioequivalence Studies.
• Bioavailability Studies.
• Phase I Pharmacokinetics.
• Single and Multiple Dose Studies.
• Replicated Designs.
• PK/PD Studies.
• Drug-Drug Interactions.
• Food-Effect.
• Pilot Studies.
• In Vivo- in Vitro Correlation.
• Special Populations Studies.

Services

Documentation

• Design study and prep the investigative protocol.
• Designing and Drafting the Informed Consent.
• Designing and Preparing the Case Report Forms.
• Development of Source Documents and study folders.
• Clinical Documentation Management.

Regulatory

• Approval management to Ethics Committees, Teaching and Regulatory Agencies.

Clinical

• Execution of Investigative Study.
• Selection and Recruitment of Healthy Volunteer subjects and/or Patients.
• Medical, Laboratory, and Additional Exams.
• Hospitalization.
• Ambulatory Monitoring.
• Drug Management.
• Management of Source Documents and CRFs.
• Collection and Processing Biological Samples.
• Recording and Monitoring Adverse Effects.

Bio analysis

• Quantification of Active Ingredients and Metabolites in Biological Samples.

Pharmacokinetic and Statistical

• Advisory.
• Sample Size Estimation.
• Statistical Analysis Plan.
• Randomization.
• Database Design.
• Data Entry.
• Pharmacokinetic and Pharmacodynamic modeling.
• Statistical Analysis.

Drafting

• Production of Final Study Report.
• Scientific Writing from the Study: Abstracts, Full-Papers, Posters.

BioPharm

Biopharmaceutical Scientific Consulting and Strategic Advisory for the development of new products and formulations, guaranteeing the best in Vitro-In Vivo correlation.