Preclinical Pharmaceutical Capabilities
From formulation and method development to bioanalysis, toxicological, and metabolism studies - our experts at Symbiotic Research cover your requirements for preclinical drug development.
Current Capabilities:
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Process and Formulation Analysis*
- Process and Formulation Analytical Methods Development
- Drug Substance HPLC Purity Profiling, Stability Indicating Method Development
- Method Validation under GLP per FDA-CDER and ICH Regulations and Guidelines
- QA Phase Inspections and Data Review
- DS and Drug Product (DP) Impurity Identification and Characterization
- Stability Studies for DS/API (12-24M)
- Drug Substance (DS) and Drug Product (DP) Impurity Identification and Characterization
- GC Residual Solvent Analysis
- Issuance of Certificate of Analysis (COA)
- DP HPLC Purity Profiling, Stability Indicating and Assay Method Development
Bioanalysis Studies*
- LC/MS and CE/MS method development
- Method validation for drugs/metabolites per FDA or ICH
- Quantitative bioanalysis of preclinical and early clinical samples
- COA and recertification for test substances, reference and metabolite standards
- Metabolite profiling for cold and C-14 labeled compounds, ID and characterization
- Metabolite isolation/enrichment by fraction collection, prep and/or semi-prep columns
- Quantitation of test article and metabolites
Metabolism Studies*
- in-vivo analytical ADME services and in-life phase through a partnering company
- in-vivo study types include mass balance, tissue distribution, metabolite profiling / radio profiling and ID, discovery PK, formulation bioavailability screening and cassette PK
- in-vitro metabolism studies with pooled liver microsomes, hepatocytes and S9 fraction
- Interspecies comparisons in mouse, rat, dog, rabbit, pig, monkey and human
- P450 isozyme phenotyping
Other Services*
- Non-Clinical Pharmacological and Toxicological studies
- Dissolved O2 Analysis in DP
- Large-scale Synthesis Support at Manufacturing Sites
- Developing DS and DP Specifications
- Product Chemistry (i.e. physical/chemical chracterization, storage stability analysis, etc.)
Pharmaceutical aNDA Capabilities for Oncological Agents*
- USP methods Transfer and Validation
- Formulations Development
- Formulation Stability Studies
- Specification
- Drug Substance and Drug Product Manufacturing Support
Note*:
All GC related analysis are outsourced to other Tentamus GLP labs.