Publications/Presentations about FreeThink’s ASAPprime®

Y. Kondo “Chapter 6.2: Packaging and Legal Regulations; Packaging Techniques; Stability of Packaged Drugs”

The Journal of Japan Society of Pharmaceutical Machinery and Engineering

M. McMahon, et al. “Utilization of risk-based predictive stability within regulatory submissions; industry’s experience”

SpringerOpen: AAPS Open

May 2020

F. Bidet “Rethinking Dry Powder Inhaler Packaging: New Solutions to Old Challenges”

Aptar CSP Technologies

Presented at Pharmapack EU, Paris, France, February 2020

T. Rawat, et al. “Accelerated Stability Modeling of Drug Products using ASAPprime®”

Perrigo Company

Presented at AAPS PharmSci 360, San Antonio, Texas, November 2019

K. Crews, et al. “Application of FreeThink’s ASAPprime®​ Software to Analyze and Predict the Impact of Storage and Handling Temperature Excursions for Cold-Chain Handling of Netarsudil Ophthalmic Solution”

Aerie Pharmaceuticals

Presented at AAPS PharmSci 360, San Antonio, Texas, November 2019

F. Qiu, et al. “Accelerated Predictive Stability: Fundamentals and Pharmaceutical Industry Practices”

This book discusses many aspects of ASAP, with case studies.

© 2018

“Accelerated stability assessment program: a speedy and scientific approach for shelf life setting of drug product—feasibility study of Accelerated Stability Assessment Program”

IMP Quality Project, Pharmaceutical Expert Committee, Quality and Technology Committee, Japan Pharmaceutical Manufacturers Association

Pharmaceutical Technology Japan: Volume 34, Issue 5

2018

 

H. E. Williams, et al. “A comparison of drug substance predicted chemical stability with ICH compliant stability studies”

Drug Development and Industrial Pharmacy

Published online November 2018

F. Qiu “Regulatory Updates: IQ Risk-Based Predictive Stability Regulatory Sub-Team”

Boehringer Ingelheim Pharmaceuticals

Presented at Science of Stability Conference, Boston, Massachusetts, October 2018

G. Scrivens “Predicting the Long-Term Dissolution Performance of an Immediate-Release Tablet using Accelerated Stability Studies”

Pfizer

Presented at Science of Stability Conference, Boston, Massachusetts, October 2018

S. Thielges “ASAP for Parenteral Formulation Development – Solutions and Lyophilisates”

Novartis

Presented at Science of Stability Conference, Boston, Massachusetts, October 2018

D. Stephens, et al. “Risk-Based Predictive Stability for Pharmaceutical Development–A Proposed Regulatory Template”

PharmTech: Pharmaceutical Technology: Volume 42, Issue 8

August 2018

C. Rack “An Introduction to the Accelerated Stability Assessment Program”

Posted: August 2017

H. Williams, et al. “Risk-Based Predictive Stability–An Industry Perspective”

PharmTech: Pharmaceutical Technology: Volume 41, Issue 3

March 2017

M. Knopp “Stability Modeling and Package Selection”

Tablets & Capsules: CSC Publishing Inc.

May 2016

H. Li, et al. “Prediction of the Changes in Drug Dissolution from an Immediate-Release Tablet Containing Two Active Pharmaceutical Ingredients Using an Accelerated Stability Assessment Program (ASAPprime®)”

SpringerOpen: AAPS Open

2016

G. Scrivens “Predicting the Long-Term Stability of Solid-State Pharmaceuticals: ASAP (Accelerated Stability Assessment Program): Theory, Limitations and Applications”

Pfizer

Presented in London, England, March 2015

H. Forcinio “Building a Barrier in Solid-Dosage Drug Packaging”

PharmTech: Pharmaceutical Technology: Volume 39, Issue 1

January 2015

S. Thielges “ASAP Concept and Case Studies”

Janssen Pharmaceutica

Presented in London, England, March 2013

L. Chen, et al. “Accelerated Stability Assessment Study for Nicorette® Lozenge”

GlaxoSmithKline Consumer Health

Presented at AAPS Annual Meeting and Exposition, San Antonio, Texas, November 2013

C. H. Hyzer “Implementing an Accelerated Stability Assessment Program: Case Study”

Eli Lilly and Company

Presented at IVT’s Third Annual Forum on Stability Programs, December 2012