About RAS
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RAS Capabilities — PK-Based Formulation Development Strategy
RAS 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.
RAS 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)
RAS also provides meta-data search and analysis for optimal formulation development and product positioning.