ASAP Applications in Generic Products

ASAP Applications in Generic Products Bryan Wicks, Ph.D. Associate Director Boehringer Ingelheim Pharmaceuticals Inc. The typical generic pharmaceutical business model requires ascertaining as much product understanding as possible in a drastically shortened development time.  With ever changing regulatory requirements, product knowledge and robust development processes are critical in the manufacturing of a sustainable quality product.  […]

In-Use and Excursions: Stability Beyond ICH

In-Use and Excursions: Stability Beyond ICH Kenneth C. Waterman Ph.D. President, FreeThink Technologies, Inc. Branford, CT USA While there is a regulatory expectation that in-use shelf-life will be determined for multiuse packaging, there is little definition of what that testing entails. In-use conditions can be from opening of a package (e.g., breaking a heat-induction seal, HIS, […]

ASAP for Non-Traditional Factors: Dissolution, Disintegration & Color

ASAP for Non-Traditional Factors: Dissolution, Disintegration & Color Kenneth C. Waterman, Ph.D. President, FreeThink Technologies, Inc. Branford, CT USA The Accelerated Stability Assessment Program (ASAP) approach of assigning storage times to hit the dissolution failure point at a range of temperatures and relative humidities (RHs) below the critical relative humidity (CRH) at each storage condition […]

ASAP Prime 5.0: Introduction to Latest Version Release

ASAP Prime 5.0: Introduction to Latest Version Release Kenneth C. Waterman, Ph.D. President, FreeThink Technologies, Inc. Branford, CT USA The latest version of ASAPprime® Stability Software will be released shortly. It will have a number of new features: Added the cross-validated R2 (Q2) Ability to see all the isoconversion plots at once Warnings when data involve significant […]

ASAP: Theory and Fundamentals

ASAP: Theory and Fundamentals Sabine Thielges, Ph.D. Analytical Project Leader Novartis, Basel, Switzerland ASAP (Accelerated Stability Assessment Protocol) is gaining acceptance across the pharmaceutical industry as a powerful tool of predicting the effects of temperature and humidity on pharmaceutical stability.  In this presentation the theory and fundamentals of ASAP will be discussed, covering the science […]

In Silico Characterization of Thermodynamic and Kinetic Stability of Amorphous Solid Dispersions

In Silico Characterization of Thermodynamic and Kinetic Stability of Amorphous Solid Dispersions Jeffrey S. Tan, Ph.D. Senior Research Scientist, Eli Lilly and Company Indianapolis, IN, USA Amorphous solid dispersion is an important formulation platform for the delivery of poorly soluble drugs.  The solubility enhancement is achieved by disruption of the highly ordered crystalline lattice into […]

Stress Testing in Solid State: Towards a Realistic Degradation Profile

Stress Testing in Solid State: Towards a Realistic Degradation Profile Peter Persich, Ph.D. Scientist, Janssen Pharmaceuticals (J & J) Beerse, Belgium Stress testing is an important and convenient tool to predict degradation profiles and to understand drug decomposition processes. A thoroughly assessed degradation profile allows the smooth development of stability indicating methods, robust formulations, and […]

The Use of ASAP from Early to Late Pharmaceutical Development

The Use of ASAP from Early to Late Pharmaceutical Development Eduard Luss, Ph.D. Sr. Scientist, Vertex Pharmaceuticals Boston, MA, USA The presentation covers a brief overview of ASAP, experimental design and its advantages in pharmaceutical development when compared to other typical approaches.  Also, ASAP implementation in early development projects is demonstrated; including regulatory implications during […]

Case studies in Drug Packaging: Supporting Stability by Addressing Specific Preservation Challenges

Case studies in Drug Packaging: Supporting Stability by Addressing Specific Preservation Challenges Valère Logel, M.S. Head of Development, Clariant Paris, France Selecting the appropriate packaging to preserve drug products always requires calibration to the conditions specific to the application. In some instances, preservation of moisture sensitive drug products is achieved by combining commonly available packaging […]

ASAP Regulatory Strategy: Acceptance and Feedback

ASAP Regulatory Strategy: Acceptance and Feedback Elke Debie, Ph.D. Manager, CMC Regulatory Affairs, Janssen Pharmaceuticals Beerse, Belgium During this presentation the use of ASAP stability in regulatory filings will be discussed. Companies have been utilizing ASAP tools to enable development.  However, the perception is that the application of these tools has been inconsistent across the […]

Teaching Old Drugs New Tricks: Applications of ASAP in OTC Product Development

Teaching Old Drugs New Tricks: Applications of ASAP in OTC Product Development Jonathan Clark Scientist, Procter & Gamble Cincinnati, OH, USA The Over the Counter (OTC) drug market is changing. USP OTC Drug Product monographs are evolving to contain better control of API degradation products. OTC products are complex formulations, often containing solvents, dyes, flavors, […]

Analysis of Unstable Degradation Impurities and their Quantification without Isolation using Multiple Linear Regression

Analysis of Unstable Degradation Impurities and their Quantification without Isolation using Multiple Linear Regression John M. Campbell, Ph.D. Investigator, GlaxoSmithKline Philadelphia, PA, USA This presentation discusses a novel methodology developed for calculating the relative response factors (RRFs) of two highly unstable degradation impurities without isolation using only HPLC-UV data. Subsequent correction of HPLC peak areas […]

Understanding Importance of Water Sorption Isotherm Shape, Hysteresis, and Models on Pharmaceutical Materials

Understanding Importance of Water Sorption Isotherm Shape, Hysteresis, and Models on Pharmaceutical Materials Daniel Burnett, Ph.D. Director of Science Strategy, Surface Measurement Systems, Ltd. Allentown, PA, USA This educational seminar will focus on the interactions of water vapor and understanding physicochemical water sorption isotherms on pharmaceutical ingredients.  Moisture and/or humidity has significant importance for pharmaceutical […]

Drug Degradation Mechanisms

Drug Degradation Mechanisms Steven Baertschi, Ph.D. President, Baertschi Consulting, LLC Indianapolis, IN, USA Developing an understanding of the degradation pathways available to drug substances and associated formulated products is an important part of establishing the “intrinsic stability” characteristics of a drug.  This talk will focus on several case studies of degradation mechanisms, highlighting the importance of […]

Dr. Jonathan Clark

Jonathan Clark, Ph.D. Scientist Procter & Gamble A native of Dayton, OH, Jonathan received his B.S. in Chemistry from Butler University in Indianapolis before pursuing his Ph.D. in Analytical Chemistry (separation science) under Dr. Susan Olesik at the Ohio State University.  After receiving his Ph.D. in the fall of 2010, he continued his training in […]

Dr. Debbie Elke

Dr. Elke Debie, Ph.D. Manager, CMC Regulatory Affairs Janssen Pharmaceuticals Dr. Elke Debie earned a Ph.D. in Chemistry from the University of Gent. She did her Ph.D. thesis on Vibrational Circular Dichroism (VCD), an analytical technique to determine the absolute configuration of chiral molecules in solution. She did a post-doctoral assignment as a visiting scientist […]

Dr. Eduard Luss

Eduard Luss, Ph.D. Sr. Scientist Vertex Pharmaceuticals Dr. Eduard Luss received his BSc and PhD in Organic Chemistry under the supervision of Dr. Craig Forsyth, from the University of Minnesota, Twin Cities, MN. After completion of his PhD, he held a postdoctoral position at the Massachusetts Institute of Technology (Prof. Stephen L. Buchwald). Postdoctoral studies […]

Dr. Sabine Thielges

Sabine Thielges, Ph.D. Analytical Project Leader Novartis In 2005, Dr. Sabine Thielges obtained her Ph.D. from Mulhouse University Ph.D. in Organic and Medicinal Chemistry under the supervision of Prof. J. Eustache on New approaches towards the treatment of mycobacterial infections. Sabine then spent 3 years as a postdoctoral fellow, at McGill University, Quebec with Prof. N. […]