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Bioavailability - Bioequivalence Studies

Bioequivalence

Bioavailability - Bioequivalence Studies

We are leaders in Argentina in the design, execution and analysis of bioavailability, bioequivalence and pharmacokinetic studies.

Types of studies

Studies we conduct

Bioequivalence Trials
Bioavailability Trials
Phase I Pharmacokinetics
Single and multiple dose
Replicate designs
Pk/Pd Trials
Drug-Drug Interaction
Food Effect
Pilot Trials
In Vivo-in Vitro Correlation
Special Populations

How we work

Services by stage

Study Design and Research Protocol Preparation
Design and Drafting of Informed Consent
Design and Preparation of Case Report Forms
Development of Source Documents and Study Files
Clinical Documentation Management

Approval Management with Ethics Committees, Teaching Committees and Regulatory Agencies

Execution of the Research Study
Screening and Recruitment of Healthy Volunteer Subjects and/or Patients
Medical Examinations, Laboratory and Complementary Testing
Hospitalization
Ambulatory Follow-up
Drug Management
Source Document and CRF Management
Collection and Processing of Biological Samples
Recording and Follow-up of Adverse Events

Quantification of Active Ingredients and Metabolites in Biological Samples

Consulting
Sample Size Estimation
Statistical Plan Development
Randomization
Database Design
Data Entry
Pharmacokinetic and Pharmacodynamic Modeling
Statistical Analysis

Generation of the Final Study Report
Scientific Writing of the Study: Abstracts, Full Papers, Posters

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

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Conducting Clinical Research studies from Phase I to IV with the highest quality standards.

Pharmacovigilance Argentina

Good Pharmacovigilance Practices program under ANMAT regulations.

Clinical Study Monitoring and Coordination Services

Monitoring and coordination for Phase 1, 2, 3 and 4 studies.