Nonclinical Sciences
The main goals of preclinical development are to determine a starting, safe dose for first-in-human studies while assessing the potential toxicity of biopharmaceutical drugs, medical devices and diagnostics.
NGT BioPharma Consultants collaborates with clients to support and integrate multidisciplinary scientific evaluations essential for characterizing a new molecular entity’s properties, enabling progression into the clinic and initiation of first-in-human (FIH) trials. These evaluations encompass pharmacology for safety and efficacy, toxicology, pharmacokinetics, and the CMC attributes that characterize the manufacturing processes. Recognizing the interdependencies among these studies, we leverage our collective expertise to design nonclinical plans that support the drug candidate’s intended clinical indication and development pathway.
Services
To support your team in navigating the scientific complexities of drug development, NGT possesses extensive subject matter expertise contributing to a multi-disciplinary team who can both advise on or lead the development of strategies and experimental approaches needed to advance drug candidates through nonclinical (preclinical) and early clinical evaluations. Our services include:
Strategy
- Nonclinical strategies to support clinical development plans and the proposed indication
- Exploratory and investigative toxicology strategies
- Nonclinical study alignment with regulatory strategies
- IND-enabling toxicology study strategies and interpretation of results, including e.g., pathology, PK/PD, together with long-term and specialty toxicology evaluations
Study Support
- Pharmacokinetic and metabolism profiling
- PK/PD evaluation, preliminary human dose/exposure projections and safety margins
- Nonclinical pharmacology and translational assessments
- PK/PD modeling support and evaluate predictive models
- Coordinate and oversee the outsourcing of laboratory nonclinical studies
Get in touch
For additional information pertaining to the Nonclinical Sciences service area, please contact Mike Placke or our CEO Michael O'Brien via the contact information provided below. Alternatively, please fill out the Inquiry form and we will get back to you within 48 hours.
