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E-book

Title Good cascade impactor practices, AIM and EDA for orally inhaled products / edited by Terrence P. Tougas, Jolyon P. Mitchell, Svetlana A. Lyapustina
Published New York : Springer, 2013

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Description 1 online resource
Series 2012-2013 Springer E-Books - Biomedical & Life Sciences
Contents Introduction / Terrence P. Tougas, Jolyon P. Mitchell -- Current Approaches to APSD Measurements of OIPs Based on Inertial Impaction / Jolyon P. Mitchell, Daryl L. Roberts -- Physical Causes of APSD Changes in Aerosols from OIPs and Their Impact on CI Measurements / Helen Strickland, Beth Morgan -- Good Cascade Impactor Practices / Jolyon P. Mitchell -- The AIM and EDA Concepts: Why They Are Needed and How They Fit Together / Jolyon P. Mitchell, Terrence P. Tougas -- Product Life Cycle Approach to Cascade Impaction Measurements / Richard Bauer, J. David Christopher -- Theoretical Basis for the EDA Concept / Terrence P. Tougas, Jolyon P. Mitchell -- Performance Characterization of EDA and Its Potential to Improve Decision Making in Product Batch Release / J. David Christopher, Helen Strickland -- Verification of the EDA Concept Through an Assessment of Theoretical Failure Modes, Failure Mode Analysis, and Case Studies with Real Data / Helen Strickland, Beth Morgan -- Validating AIM-Based Instrumentation and Associated Measurement Techniques / Mark Copley, Jolyon P. Mitchell -- The Regulatory and Compendial Pathways to Acceptance for AIM and EDA Concepts / Steven C. Nichols, Jolyon P. Mitchell -- Applying the AIM Concept in Support of Developing Improved In Vitro-In Vivo Relationships for OIPs / Jolyon P. Mitchell, Mark Copley -- Future Directions for the AIM and EDA Concepts / Terrence P. Tougas, Jolyon P. Mitchell -- Conclusions / Terrence P. Tougas, Svetlana A. Lyapustina
Summary The purpose of this publication is to introduce a new, simpler and more effective way in which to interpret pharmaceutical aerosol particle size data from orally inhaled products (OIPs). Currently, the compendial and regulatory requirements dictate the need for measurements by full resolution multi-stage cascade impactor (CI), a process that is demanding for the operator, time consuming, prone to experimental error, and challenging for method transfers from one laboratory to another. Furthermore, we shall show that the current practice of reducing information from mass-weighted aerodynamic par
Notes Includes index
Bibliography Cludes bibliographical references
Notes English
Print version record
Subject Pharmaceutical chemistry.
Drugs -- Dosage forms.
Aerosol therapy.
Drugs.
Administration, Inhalation
Chemistry, Pharmaceutical
Dosage Forms
Pharmaceutical Preparations
MEDICAL -- Drug Guides.
MEDICAL -- Nursing -- Pharmacology.
MEDICAL -- Pharmacology.
MEDICAL -- Pharmacy.
Drugs
Aerosol therapy
Drugs -- Dosage forms
Pharmaceutical chemistry
Form Electronic book
Author Tougas, Terrence P
Mitchell, Jolyon P
Lyapustina, Svetlana A
ISBN 9781461462965
1461462967