Application of Modeling and Simulation in Long-Acting Injectable Product Development
Discuss advances in mechanistic models to simulate in vitro and in vivobehavior of long acting injectables.
From Preclinical to Clinical Drug Product Development: A Path for Smooth Transition
It is challenging to establish a standard approach for moving from preclinical to clinical phases of development. Many hurdles exist during formulation selection and for extrapolation of doses from animals to humans; what may have worked well for one drug candidate may not be appropriate for others. This presentation will provide a general framework/strategy to follow when moving from preclinical to clinical studies (FIH) based on risk identification and mitigation focusing on the application of mechanistic modeling and simulation (PBPK).
Absorption Predictions: Current Capabilities and Knowing the Gaps
Number of different processes contribute to net drug absorption
Complex Delivery Routes and Generics: The Next Frontier for PBBM/PBPK Modeling
Generic drug development for locally acting drug products is a fast-growing field of interest
Data required to build a fit-for-purpose PBPK model: How much is necessary?
PBPK/PBBM model development can be initiated at any stage of product development
Predictive Dissolution Modeling with Clinically Relevant Specifications
The role of biopharmaceutics risk assessment
Simulations Plus General Overview
Our solutions inform the entire drug development process
API Enabled HTPK Deployment of Early PK Assessments for Drug Discovery
Mechanistic High-Throughput PK
Your #1 Ranked Team for Exposure and Safety Solutions!
Do you think modeling and simulation might help?
Building a Machine Learning Model for Tautomer Prediction
Many drug molecules exhibit tautomerism
AI-driven Lead Discovery
Computer based de novo drug design background
Patient-Centric Design of Long-Acting Injectable Drug Products
PBPK model description
Current status and gaps in mechanistic in-silico modeling for clinical translation and performance
Exploring mechanisms affecting in vivo dissolution of low-solubility compound crystalline suspensions
Post-Approval/Generics Track: Pushing the Boundaries Beyond – NextGen Session Panel Discussion and Live Q&A
Q&A presented at SLP MIDD+ Virtual Conference February 16th-17th, 2022
Post Approval: Generics Track – Assessing the Potential for Hepatotoxicity for Combination Therapy of Valproate (VPA) and CBD using Quantitative Systems Toxicology (QST)
Presented by Vinal Lakhani at SLP MIDD+ Virtual Conference February 16th-17th, 2022
Clinical Track: Pushing the Boundaries Beyond – NextGen Session Panel Discussion and Live Q&A
Q&A presented at SLP MIDD+ Virtual Conference February 16th-17th, 2022
Clinical Track Poster Presentation: Count data model for Alzheimer disease progression MMSE score using MonolixSuite®
Presented by Pauline Traynard at SLP MIDD+ Virtual Conference February 16th-17th, 2022
Post-Approval/Generics Track Poster Presentation: Use of PBBM to Establish Dissolution Safe Space via IVIVR for Concor®
Presented by Joyce Macwan at SLP MIDD+ Virtual Conference February 16th-17th, 2022
Post-Approval/Generics Track Poster Presentation: Relationship between Pimavanserin Exposure and QTc Interval in Patients with Schizophrenia: Modelling Analysis from Randomized, Double-Blind, Placebo-Controlled Studies
Presented by Hannah Huang at SLP MIDD+ Virtual Conference February 16th-17th, 2022