Preliminary Program - American Association of Pharmaceutical ...

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30 2009 AAPS Annual Meeting and Exposition AAPS Analysis and Pharmaceutical Quality (APQ) Programming New INTERACTIVE FEATURE for all Roundtable Sessions! Click on roundtable moderator names to submit questions that you would like to be addressed at the roundtable session in Los Angeles. Sunday, November 8, 2009 8:30 am – 4:00 pm Developing Biorelevant Dissolution Test Methods with an Emphasis on QbD Short Course #3 An additional fee is required to attend this short course Biorelevant dissolution testing is playing a critical role in guiding early phase formulation development and linking product/process design space and patient needs. This short course will provide pharmaceutical scientists and regulatory personnel with fundamental training on dissolution method development, following the principles of QBD. A presentation by a representative from the U.S. Food and Drug Administration will stress the importance of having a discriminating biorelevent dissolution test, and what is now expected in the quality of the dissolution test. Modeling and simulation will be presented as a helpful tool in the early phase efforts to link dissolution methods to in vivo performance. There will be an emphasis on finding pertinent product and substance information in the early phases. Case studies for dissolution method development that focuses on in vivo relevance and correlation will be presented. The use of Design of Experiments (DOE) in dissolution method development and understanding will be discussed. Moderators Vivian Gray V.A. Gray Consulting, Inc. Qingxi Wang, Ph.D. Merck and Co., Inc. Biorelevant Dissolution Testing: Characterizing the Product for the Patient Arzu Selen, Ph.D., invited U.S. Food and Drug Administration Biorelevant Dissolution Method in Early Phase Drug Development Yin Mao, Ph.D. Merck and Co., Inc. Developing a Biorelevant Dissolution Method: Points for Consideration and Case Studies Nikoletta Fotaki, Ph.D. University of Bath Modeling and Simulation Approaches for Designing and Understanding In Vitro Dissolution Tests John Crison, Ph.D. Simulations Plus, Inc. QbD Approach to Dissolution through Understanding of the Release Mechanisms and Critical In Vivo Parameters Qingxi Wang, Ph.D. Merck and Co., Inc. Role of DoE in Developing Biorelevant Methods Kimberly Gallagher, M.S. Merck and Co., Inc. Monday, November 9, 2009 MONDAY MORNING ROUNDTABLES Funded by a Grant from 8:00 am – 10:00 am Evaluation of the Regression Type in LC-MS/MS Bioanalytical Methods Roundtable U.S. Food and Drug Administration (FDA) guidelines for bioanalytical method validation clearly state that the calibration curve should cover the entire anticipated range, the simplest model that adequately describes the concentration — response relationship should be used, and selection of weighting and use of a complex regression equation should be justified. In many bioanalytical methods, the range only fits complex regression equations or requires the dilution of higher concentration samples to fit a linear regression. At present, the FDA guidelines do not mention which is the best approach to follow. Therefore, this topic is still debated in the pharmaceutical industry. This roundtable will focus on discussing the precision and accuracy of QCs and diluted QCs read off linear and quadratic calibration curves to determine which option is preferable. Moreover, current industry practice for GLP bioanalytical methods assesses precision/accuracy at 4 levels: LLOQ, QC-Low, QC-Mid, and QC-High. Often, no evaluation of precision/accuracy above the QC-High is performed which leaves the concentrations between QC-High and ULOQ considered to be less rigorously evaluated. Since the entire span of the calibration curve is considered validated, backcalculated concentrations of unknown samples falling in the upper portions of calibration curves are routinely reported. This practice could be considered acceptable for linear curves but it could be considered questionable for quadratic curves. Indeed, for quadratic curves a given change in instrument response can have more impact on the back-calculated concentrations in the upper part of the curve compared to the lower portion due to changing slope. Data in the literature suggest that quantitation in upper portions of calibration curves, even employing quadratic regression algorithms, produces the same reliable back-calculated results as in mid or lower portions of the calibration curve. However, since the “quadraticity” of a non-linear calibration curve could be significantly accentuated by low ionization efficiency, detector saturation and solubility issues, it is further suggested to always evaluate accuracy/precision at the ULOQ level during method development. Moderator Fabio Garofolo, Ph.D. Algorithme Pharma Inc. Evaluation of Precision, Accuracy and Dilution Reliability in Upper Portions of Quadratic Calibration Curves Fabio Garofolo, Ph.D. Algorithme Pharma Inc. The Importance of Using the Linear Fit and the Simplest Fit Over the Best Fit Douglas M. Fast, Ph.D. Pfizer Global R&D The Importance of Using the Quadratic Fit and the Best Fit Over the Simplest Fit Saleh Hussain, Ph.D. Consultant MONDAY AFTERNOON ROUNDTABLES 2:00 pm – 4:00 pm IVIVC for Establishing Clinically Relevant Specifications Roundtable In vitro release dissolution testing plays a dual role in the drug development life cycle. In one role, laboratory test results are used as an indicator of product quality. In the other role, the test results can indicate or predict in vivo performance. In both cases, test specifications that are meaningful are desired. This round table represents an opportunity to bridge a knowledge gap between the two practices (clinical and laboratory) for those seeking in vitro/in vivo correlations. The presentations will include case studies, ideas, and methodologies for designing and interpreting in vitro release tests that indicate in vivo performance of dosage forms and drug delivery systems. The session will also include a discussion of the situations where IVIVC can be expected to work and conversely when success is not likely.
31 2009 AAPS Annual Meeting and Exposition AAPS Analysis and Pharmaceutical Quality (APQ) Programming Moderators Ali Rajabi-Siahboomi, Ph.D. Colorcon Alger D. Salt, M.S. GlaxoSmithKline plc Challenges in Setting Clinically Relevant Dissolution Specification from In Vivo and In Vitro Correlations Arzu Selen, Ph.D., invited U.S. Food and Drug Administration Challenges in Setting Clinically Relevant Dissolution Specification from In Vivo and In Vitro Correlations Nikoletta Fotaki, Ph.D. University of Bath IVIVC: Factors and Conditions for Success Mario González, Ph.D. P’Kinetics International, Inc. MONDAY AFTERNOON SYMPOSIA Funded by a Grant from 2:00 pm – 4:30 pm Process Analytical Technologies in API Manufacturing Symposium Currently, pharmaceutical industry uses different on-line monitoring techniques (PAT) to understand and control manufacturing processes (reaction monitoring, crystallization and polymorphic transformations, particle engineering, drying, milling, solvent recovery and fractionation, etc.). In this symposium, the application of different process analytical technologies (online LC, Raman, FT-IR, and Near IR spectroscopy), and the challenges to the implementation of PAT in API manufacturing area will be discussed. Moderators Arya P. Jayatilaka, Ph.D. Pfizer, Inc. Mukund “Mike” Yelvigi Wyeth Pharmaceuticals PAT in Support of API Manufacturing: Some Case Studies Steve Hammond, Ph.D. Pfizer, Inc. Raman Spectroscopy for Understanding API Crystallization Lynne Taylor, Ph.D. Purdue University On-line HPLC for Improved Monitoring and Control of Pharmaceutical API Processes Rick Cooley Dionex Corp Overcoming Challenges to the Implementation of PAT in API Manufacturing Andrew Lange, Ph.D. Vertex Pharmaceuticals, Inc. JOINT MEMBERSHIP MEETING AND RECEPTION 5:30 pm – 7:00 pm Analysis and Pharmaceutical Quality (APQ) Section Joint Membership Meeting and Reception Tuesday, November 10, 2009 Graduate Student Symposium 8:30 am – 11:00 am AAPS Graduate Student Symposium in Analysis and Pharmaceutical Quality (APQ) Sponsored by TUESDAY MORNING ROUNDTABLES 9:00 am – 11:00 am How to Face and Successfully Defend FDA and Other Regulatory Audits Roundtable In this session, we will share the experiences of U.S. Food and Drug Administration (FDA) officers, and clients’ experience on how to face FDA scientific compliance or routine audits. This discussion will provide an insight on how to manage a crisis into a less painful and manageable exercise. Moderators Prasad N.V. Tata, Ph.D., F.C.P. Covidien/Mallinckrodt, Inc. Raja Velagapudi, Ph.D. Barr Laboratories Audits Have a Purpose — Understand Them and Comply with Them C.T. Vishwanathan, Ph.D. U.S. Food and Drug Administration Preparation of a Bioanalytical Laboratory for a Successful and Regulatory Audit Chinna Pamidi, Ph.D. Cetero Research My CRO is Under Audit – What Should I Do? Prasad N.V. Tata, Ph.D., F.C.P. Covidien/Mallinckrodt, Inc. TUESDAY AFTERNOON ROUNDTABLES Funded by a Grant from 2:00 pm – 4:00 pm Stability Evaluations Using Alternate Accelerated Conditions Roundtable In the current environment, clinical materials are manufactured, packaged, tested, and distributed worldwide. During transition, there are inherent changes of degradation, physical stability, dissolution rate, and particle size that may be affected; thus increasing risk to clinical materials. This session will explore options to effectively maximize the data collected using predictive stability tools to support establishment of shelf-life for clinical materials and minimize the number of stability studies to support clinical program. This roundtable will discuss the use of alternate accelerated/stress conditions, scientific understanding and predictive stability tools as an aid in the development to reduce risk and increase extrapolation robustness while maintaining product safety. Challenges to establish alternative accelerated conditions for unusual dosage forms and implication of physical and chemical changes on formulation/packaging and shipping strategies. Studies supporting shipment of clinical and commercial product, including controlling the shipment, monitoring and justifying excursions that may be observed. Moderators Kim Huynh-Ba, M.S. PHARMALYTIK Andrea Panaggio, Ph.D., M.S., R.Ph. Bristol-Myers Squibb
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