In Silico Modeling Methods for Generic Drug Products: Applications and Expectations

This session will focus on physiologically-based pharmacokinetic (PBPK) modeling as an alternative tool to currently recommended in vivo bioequivalence studies in support of regulatory submission of locally-acting and oral generic drug products. Via these webinars we want to fill the basic educational gap in understanding the concepts of and strategies for in silico modeling and simulations as applied to generic drug products by giving participants an opportunity to learn from experts in this field. As such, this session will feature two speakers from Simulations Plus, Inc.

Presenter 1:

Maxime Le Merdy, Senior Scientist, Simulations Plus, Inc.: PBPK Modeling of Locally-Acting Drug Products for Regulatory Submission

Areas Covered:

• Bioequivalence challenges for locally-acting drug products.
• PBPK models for ophthalmic drug products.

Presenter 2:

Denise Morris, Director, Quantitative Clinical Pharmacology, Cognigen Corporation, a Simulations Plus company: PBPK Modeling of Oral Dosage Forms for Regulatory Submission

Areas Covered:

• Virtual bioequivalence: Biowaiver for manufacturing changes.
• Virtual bioequivalence: Biowaiver for ANDA submissions.
• Points to consider for assessment of bioequivalence using PBPK modeling and simulation.

Topics under consideration for future SAAMnow webinars:

• Design of bioequivalence studies: protocol development and writing
• Beyond bioequivalence: phase I studies commonly needed to support 505(b)(2) applications
• Secrets to successful pre-IND meetings for 505(b)(2) NDAs
• Endogenous compounds: issues in study design, baseline correction, and bioanalytical
• In-vitro in-vivo correlation (IVIVC)
• In vitro dissolution profile comparisons
• In vitro binding studies
• Vasoconstrictor studies: issues in design and data analysis
• Formulation and manufacturing changes: to SUPAC and beyond
• Complex generics: drug-device combinations
• Dermal product approval process for ANDAs (IVRT and IVPT)
• PK and statistical considerations in single- and multiple-dose bioequivalence studies