Nonclinical
Atheln’s nonclinical experts can support companies through all stages of development
Atheln’s nonclinical experts have extensive experience in the regulated markets and can support companies through all stages of development always in close collaboration with the clinical, CMC and regulatory teams:
- Evaluating the target product profile (TPP) to understand the clinical requirements and design a nonclinical development plan that will support the clinical study design and enable regulatory filing
- Capturing early-stage data in IND ready reports
- Evaluating and advising on appropriate animal models
- Advising on CRO selection and managing CRO relationships
- Planning IND-enabling Pharmacology/ PK-ADME / Toxicology programs
- Conducting study protocol design and interpretation
- Advising on bioanalytical assay development and validation
- Reviewing and evaluating results and study reports
- Writing regulatory filings and supporting meetings with regulators
Atheln’s Nonclinical services include:
- In vitro and in vivo efficacy model recommendations
- Route of administration recommendations
- In vitro and ex vivo permeability study designs
- Metabolism/catabolism analysis
- Transporter/ion channel liability
- Clinical dose extrapolations
- GLP/non-GLP local and systemic safety evaluation
- Toxicokinetics evaluation
- Immunogenicity study design and data evaluation
- Pathology peer reviews
