About RAS
Expertise and Resources
- 505(b)(2) Submissions
- RAS Data Sheet
® - PBPK Data Sheet
Related Products
PK-Based Formulation Development Strategy
Pharsight makes optimal use of information about your compound's pharmacokinetic (PK) profile to guide formulation and reformulation strategies from early-phase development to post-approval.
Our scientists use the latest tools for efficient in vivo-in vitro correlation (IVIVC) analysis, featuring the IVIVC Toolkit for WinNonlin. Specific IVIVC applications include:
- Modified-release formulation & Super Generics [505(b)(2)]. RAS offers extensive experience in studies supporting 505(b)(2)submissions.
- Fixed-Dose Combination (>2 products combined into 1 tablet formulation).
- Drug delivery systems (e.g., transdermal, parenteral, pulmonary)
Pharsight also provides meta-data search and analysis for optimal formulation development and product positioning.