Pre-clinical studies
General Approach:
- Tailored Support:
- Pays particular attention to the context and objectives of each project.
- Optimizes implementation using the best-adapted resources (considering budget, quality, and deadlines).
- Comprehensive Development Support:
- Offers support at every stage of product development, from proof of concept to regulatory studies.
- Has experience meeting current guidelines with GLP certification since 2007.
- Ensures reliability and traceability of project results.
Phatophy’s Know-How:
- Study Design:
- Provides advice and helps in the elaboration of study designs.
- Project Implementation:
- Implements and coordinates resources necessary for projects.
- Study Follow-Up:
- Monitors and executes every step of the study.
- Documentation:
- Designs documentation including protocols, data collection, and study reports.
- Statistical Analyses:
- Utilizes STATGRAPHICS Centurion and KINETICA software for statistical analyses and results interpretation.
Types of Studies Conducted:
- Pharmacokinetics and Bioequivalence Studies:
- Analyzes absorption, distribution, metabolism, and elimination of active substances and metabolites.
- Conducts non-compartmental PK analyses and validated statistics.
- Safety and Toxicity Evaluations:
- Evaluates the safety, local and general toxicity of products, including biocompatibility of Medical Devices.
- Residue Depletion Studies:
- Assesses the depletion of medicinal residues in animal productions for human consumption.
- Determines withdrawal periods.
- Palatability Tests:
- Conducts palatability tests for various product forms.
- Animal Models Development:
- Develops animal models.
- Efficacy Tests:
- Evaluates the effectiveness of pharmaceutical and immunological medicines.
- Tolerance and Mechanical Properties:
- Evaluates tolerance and mechanical properties, as well as the degradation of biomaterials.
Phatophy’s expertise spans a wide range of pre-clinical studies, showcasing a holistic approach to supporting clients in the development of their products. If you have any specific questions or if there’s more you’d like to share about your pre-clinical study services, feel free to provide additional details or ask for specific information.