ICON DEVELOPMENT SOLUTIONS PRESENTATION ARCHIVE

Nanomedicine Tools: Applications of Nanotechnology in Drug Delivery
International Pharmaceutical Federation (FIP) Congress, September 2007
Kadriye Ciftci, Ph.D.

Challenges of Needle-free Vaccine Delivery Technologies
International Pharmaceutical Federation (FIP) Congress, September 2007
Kadriye Ciftci, Ph.D.

Designing MR Formulations Utilizing PK and IVIVC Models
AAPS 41st Annual Pharmaceutical Technologies Arden Conference, January 2006
David Young, Pharm.D., Ph.D.

Designing MR Formulations Utilizing PK Principles
AAPS 41st Annual Pharmaceutical Technologies Arden Conference, January 2006
David Young, Pharm.D., Ph.D.

IVIVC of Poorly Water Soluble Drugs
Philadelphia Pharmaceutical Forum Meeting, May 2005
Stuart Madden, Ph.D.

Automated Evaluation of Population Pharmacokinetic and Pharmacodynamic Models
AAPS Meeting 2004
W. Bachman, L. Gibiansky

A Useful Tool in the Development of Drug Delivery Systems
AAPS Meeting 2004
David Young, Pharm.D., Ph.D.

Development of a Population Pharmacokinetic Model for TZT-1027
AAPS Meeting 2004
C. Farrell, H. Pentikis, M. Yamaguchi, M. Satomi, J. Verweij , M. Dejonge, P. Schöffski, B. Thate, J. Wanders, A. Jenner

Evaluation of the Predictability of a Level A IVIVC Model
AAPS Meeting 2004
C. Farrell

In Vitro-In Vivo Correlation (IVIVC) of Poorly Water Soluble Drugs
AAPS Conference on Pharmaceutics and Drug Delivery
David Young, Pharm.D., Ph.D.

The Effect of Rifaximin on the Pharmacokinetics of a Single Dose of Ethinyl Estradiol and Norgestimate in Healthy Female Volunteers
ASCPT Meeting(2004)
A. King, M.D. O. Marshall, B.S. M. Connolly, Ph.D. A. Kamm, Ph.D. H.Boxenbaum, Ph.D. C. Trapnell, M.D.

The Effect of Rifaximin on the Pharmacokinetics of Single Doses of Intravenous and Oral Midazolam in Healthy Volunteers
ASCPT Meeting(2004)
A. King, M.D. R. Laurie, Pharm.D. M. Connolly, Ph.D. A. Kamm, Ph.D. H.Boxenbaum, Ph.D. C. Trapnell, M.D.

Use of a Linux Cluster with PDx-Pop™ and NONMEM® v5 to Streamline Population Pharmacokinetic Analysis
AAPS Meeting (2003)
William Bachman, Ph.D.

The Effect of Ethnicity on the Pharmacokinetics of Sirolimus: A Population Pharmacokinetic Analysis of Phase I Data
AAPS Meeting (2003)
Helen Pentikis, Ph.D.

In Vitro In Vivo Correlation of Controlled Release Parenterals
AAPS Meeting (2003)
David Young, Pharm.D., Ph.D.

Individual Deconvolution Using A Population Compartmental Approach
AAPS Meeting (2003)
Colm Farrell, Ph.D.

Development of a Level A IVIVC for a BCS Class 2 IR Product
AAPS Meeting (2003)
Siobhan Hayes, Ph.D.

A Population Analysis of Data Obtained in Phase I-III Clinical Trials of HBOC-201
ACSPT Meeting (2003)
William Knebel, Pharm.D., Ph.D., L. B. Pearce, M. Gawry, Helen Pentikis, Ph.D.

Comparison of the Pharmacokinetics and Safety of Metoclopramide Nasal Spray versus Orally Administered Metoclopramide Tablets, USP in Patients with Diabetic Gastroparesis
ACSPT Meeting (2003)
Sian Bigora, Pharm.D., R.E. Oliver, PhD, A.D. Retzios, PhD, M.E. Petrone, MD, MPH, D. S. Tierney, MD, S.P. Clausen,PhD, C.Braun Trapnell, MD

First-Order versus Michaelis-Menten Pharmacokinetic Model Selection Using a Mixture Model
ACSPT Meeting (2003)
Steven P. Riley, Pharm.D., Thomas M. Ludden, Ph.D.

Overview of In Vitro-In Vivo Correlation (IVIVC)
Assuring Quality and Performance of Sustained and Controlled Release Parenterals Workshop, February 17-18, 2003
David Young, Pharm.D., Ph.D.

Applications of In Vitro-In Vivo Correlation for Product Development & Dissolution Specifications
AAPS Expert Talks, November 11-13, 2002
Sian Bigora, Pharm.D.

Covariate Models for Population Analysis
AAPS Expert Talks, November 11-13, 2002
Helen Pentikis, Ph.D.

PDx-IVIVC™ Tools for In Vitro-In Vivo Correlation Software Demonstration
AAPS Expert Talks, November 11-13, 2002
Sian Bigora, Pharm.D.

PDx-Pop™ Tools to Expedite Population Analysis Software Demonstration
AAPS Expert Talks, November 11-13, 2002
William Knebel, Pharm D., Ph.D.

Biowaivers – Applications of Principles throughout Product Development
AAPS Expert Talks, November 11-13, 2002
David Young, Pharm.D., Ph.D.

Biopharmaceutical Approaches to the Development of New Drug Delivery Products
AAPS Expert Talks, November 11-13, 2002
David Young, Pharm.D., Ph.D.

Use of In Vitro-In Vivo Correlation (IVIVC) in Developing a Product for 505(b)(2) NDA Submission
AAPS Meeting 2002
David Young, Pharm.D., Ph.D., Colm Farrell. Ph.D., Theresa Shepard, Ph.D., Dakshina M. Chilukuri Ph.D.,

Application of Population Pharmacokinetic Approach to Minimize Animals and/or Samples in a Toxicokinetic Study
AAPS Meeting 2002
C. Garnett, J-P. Tang, William Knebel, Pharm D., Ph.D.

Population Pharmacokinetics of Tamoxifen In Pediatric females With McCune-Albright Syndrome (MAS)
AAPS Meeting 2002
C. Garnett, B.K. Birmingham, E. Gibiansky, Ph.D, S. Rubin, P. Plourde

Approaches to Developing a Level-A IVIVC for Injectable Dosage Forms
AAPS Meeting 2002
David Young, Pharm.D., Ph.D., Dakshina M. Chilukuri Ph.D., Rebecca Becker PA-C, B.A., Bigora, Sian Pharm.D., Colm Farrell. Ph.D., Theresa Shepard, Ph.D.

A Theoretical Evaluation of the PDx-IVIVC Equation: Applicability and Limitations
AAPS Meeting 2002
Theresa Shepard, Ph.D., Colm Farrell. Ph.D.

Distinct IVIVC Relationships For Different Formulation Technologies For The Same Drug
AAPS Meeting 2002
Colm Farrell. Ph.D., Theresa Shepard, Ph.D., A. M. Wilson, K. I. Cumming

The Incorporation Of Time-Scaling In IVIVC Models To Account For Apparent Non-Linear Relationships
AAPS Meeting 2002
Colm Farrell. Ph.D., Theresa Shepard, Ph.D.

Development and Validation of a Time Scaled In Vitro/In Vivo Correlation for Isosorbide-5-Mononitrate Controlled Release GEOMATRIX Formulations
AAPS Meeting 2002
Theresa Shepard, Ph.D., Myriam PharmD, M.S.

Polymeric Micelles for Parenteral Drug Delivery: Application to Paclitaxel (Genexol-PM))
AAPS Meeting 2002
David Young, Sung Chul Kim, Jaewon Yu, M.H. Seo, S.W. Kim, H.S. Oh, B.G. Rhee

Pre-NDA Changes In Formulation Or Manufacturing Process Of A Modified Release Formulation: Bridging Or No Bridging Study?
29th Annual Meeting and Exposition of the Controlled Release Society Seoul, Korea (July 2002)
David Young, Pharm.D., Ph.D., Theresa Shepard, Ph.D., Colm Farrell. Ph.D., Dakshina Chilukuri, Ph.D., Sian Bigora, Pharm.D.

Impact of Chronopharmacology in Designing Controlled Release Formulations
29th Annual Meeting and Exposition of the Controlled Release Society Seoul, Korea (July 2002)
David Young, Pharm.D., Ph.D.

Overview of In Vitro-In Vivo Correlation (IVIVC)
AAPS Workshop (April 19-20, 2001)
David Young, Pharm.D., Ph.D.

Modeling Drug Action and Disease Progression Using a Population Approach
AAPS Meeting 2000
Marc R. Gastonguay, PhD.

Pharmacokinetics and Pharmacodynamics as Related to Bioequivalence Assessment of Biotechnology Products
AAPS Meeting 2000
Thomas Ludden, Ph.D.

A Review Of The Use Of Population Pharmacokinetic Analysis Results In The Labeling For Prescription Drugs
AAPS Meeting 2000
S. E. Bigora, R. Oliver, R. Curley, H. Pentikis

The Application of the Population Pharmacokinetic Data Analysis Approach in Bridging Foreign Region and New Region Clinical Development Programs
AAPS Meeting 2000 (November)
Kimberley Jackson, Helen S. Pentikis, and Keith Chan

The Application of the Population Pharmacokinetic Data Analysis Approach in Bridging Foreign Region and New Region Clinical Development Programs
AAPS Meeting 2000 (October)
Kimberley Jackson, Helen S. Pentikis, and Keith Chan

Population Pharmacokinetics of Norastemizole (NORA) in Healthy Volunteers
AAPS Meeting 2000
W.J. Bachman, Gary Maier, Patrick Koch, David Amato, Kenneth Tripp, Sidney Degraw, and Rudolf Baumgartner

Estimation of Absorption Parameters for Trimethobenzamide (TMB) HCL After Oral, Rectal and Intramuscular (IM) Administration Using Population Mixed Effects Modeling
AAPS Meeting 2000
W.J. Bachman

Comparison of the Mean and Individual Approaches to the IVIVC Modeling
AAPS Meeting 2000
Leonid Gibiansky, Ph.D. and David Young, Pharm.D., Ph.D.

Applying in Vitro - in Vivo Correlation (IVIVC) for Setting Dissolution Specifications
Dissolution Testing Conference (June 26-27, 2000)
Leonid Gibiansky, Ph.D.

NONMEM Alphabet Soup: L2, AR(1), and INFN
East Coast Population Analysis Group Conference (June 12, 2000)
Marc R. Gastonguay

Optimizing a Bayesian Dose-Adjustment Scheme for a Pediatric Trial: A Simulation Study
American Society for Clinical Pharmacology and Therapeutics Annual Meeting (March 2000)
L. Gibiansky, Ph.D., M.R. Gastonguay, Ph.D., E. Gibiansky, Ph.D., J.S. Barrett, Ph.D.

Population Pharmacokintetic Analysis of Anti-XA Activity of Tinzaparin from a Phase III Clinical Study
AAPS Meeting (1999)
E. Gibiansky, H.S. Pentikis, and J.S. Barrett

Importance of In Vitro Sampling Schedule for IVIVC Modeling
AAPS Meeting (1999)
Leonid Gibiansky, Ph.D.

The influence of Study Design on Parameter Estimation and Identification of a Sub-Population in Population Pharmacokinetic (PK) Studies
AAPS Meeting (1999)
Kimberley A. Jackson, Sara E. Rosenbaum and Ene I. Ette

Investigating the Effects of Covariate Range and Population Size on the Ability to Detect a Continuous Covariate
AAPS Meeting (1999)
William Knebel, Pharm.D., and David Young, Pharm.D., Ph.D.

Population Pharmacokinteics in Pediatric Patients Using Bayesian Approaches with Informative Prior Distributions Based on Adults
AAPS Meeting (1999)
Marc R. Gastonguay, PhD, Leonid Gibiansky, PhD, William R. Gillespie, Ph.D,
Ko-Chin Khoo, MS, and the PPRU Network

Setting Dissolution Specifications On An In Vivo Scale
AAPS Meeting (1999)
Leonid Gibiansky, Ph.D., William Gillespie, Ph.D., David Young, Pharm.D., Ph.D.

Drug-Excipient Interaction and the Effect on Absorption
AAPS Meeting (1999)
Kimberley Jackson, PhD, Sonia Pant, David Young, PharmD, PhD

Role of Correlating In Vitro and In Vivo Characteristics in Post-Approval Changes
WorldPharm 99
David Young, PhD

Applying Modeling and Simulation to Improve the Design of a Clinical Efficacy Trial
ASCPT Meeting (1999)
Marc R. Gastonguay, PhD, Helen S. Pentikis, PhD, Melvin T. Alexander, MS, Lucy Lee

Modeling Uncertainty in Clinical Trial Simulations: A Bayesian Approach
ASCPT Meeting (1999)
M.R. Gastonguay, PhD, W.R. Gillespie, PhD, M. Sale, MD, S.L. Beal, PhD

Population Pharmacokinetics Analysis of Flesinoxan
ASCPT Meeting (1999)
W.J. Bachman, J. Brennan, P. Boon, A. Hage, and M. de Vries

A PK/PD Model for Perflubron Emulsion (Oxygent TM) in Cardiopulmonary Bypass (CPB) Patients
ASCPT Meeting (1999)
W.J. Bachman, W. Cheung, P. Keipert