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AAPS (American Association of Pharmaceutical Scientists)


Keynote: From Preclinical to Clinical Drug Product Development- A Path for Smooth Transition
Presented by: VP, Regulatory Affairs, Sandra Suarez-Sharp
Date: Tuesday, October 18th, 2022
Time: 1:30 PM – 2:30 pm ET
Location: 254 A


Title: Physiologically Based Pharmacokinetic (PBPK) Modeling of Rifampicin and Its Application for Drug-Drug Interaction with Midazolam in Adults
Presented by: Scientist II, Suvarchala Avvari
Description: The purpose was to develop a mechanistic PBPK model for RIF which accounts for all the relevant mechanisms after IV and PO administration in healthy and tuberculosis (TB) subjects. This model was validated by predicting effect of RIF administration on midazolam (MDZ) PK.
Poster #: W0930-05-26
Date/Time: Wednesday, October 19th at 9:30 am, Forum #5, Monitor#26

Title: Establishment of preclinical mechanistic in vitro-in vivo correlations for long-acting injectable suspensions
Presented by: Scientist I, Daniela Silva
Description: The purpose of this study was to use different modeling approaches to mechanistically understand the in vivo performance of different long-acting injectable suspensions (reference listed drug of medroxyprogesterone acetate and formulation variants) in preclinical species and to establish an in vitro – in vivo correlation.
Poster #: M1030-02-07
Date/Time: Monday, October 17th at 10:30 am, Forum # 2, Monitor #07.

Title: ILDsym successfully simulates SSc-ILD pathophysiology and inter-patient variability
Presented by: Principal Scientist, Zackary Kenz
Description: The purpose of this work was to develop a mechanistic QSP model for systemic sclerosis (SSc)-associated interstitial lung disease (ILD) pathophysiology validated with clinical data and capable of representing responses to existing and novel treatments.
Poster #: M1330-11-62
Date/Time: Monday, October 17th at 1:30 pm, Forum #11, Monitor #62.

Title: Use of Quantitative Systems Toxicology (QST) to Identify Potential Intrinsic Mechanisms of Toxicity
Presented by: Principal Scientist, Christina Battista
Description: The purpose of this study was to investigate whether a QST model could account for liver chemistry abnormalities observed during BAY1128688 treatment and provide insight into mechanisms driving hepatotoxicity and bilirubin elevations.
Poster #: M1530-11-64
Date: Monday, October 17th at 3:30 pm, Forum #11, Monitor #64.

Title: Clinical Ocular Exposure Extrapolation Using PBPK Modeling and Simulation: Gatifloxacin Solution Case Study
Presented by: Scientist II, Farah Al Qaraghuli
Description: Development and validation of gatifloxacin administration as an ophthalmic solution in rabbits as well as predicting its clinical exposure in humans.
Poster #: W1230-02-1
Date/Time: Wednesday, October 19th at 12:30 pm, Forum #02, Monitor #10.

Visit us at Booth #1219.

Save-the-Date: October 18th for the 18th Annual SLP Forum
(more information coming soon)