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International stability testing

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Published by Interpharm Press in Buffalo Grove, Ill .
Written in English

Subjects:

  • Drug stability -- Standards.,
  • Drug Stability.,
  • Guidelines.,
  • Pharmaceutical Preparations -- analysis.,
  • Pharmaceutical Preparations -- standards.,
  • Drug Approval.

Book details:

Edition Notes

Includes bibliographical references and index.

Statementedited by David J. Mazzo.
ContributionsMazzo, David J.
Classifications
LC ClassificationsRS424 .I58 1999
The Physical Object
Paginationxviii, 332 p. :
Number of Pages332
ID Numbers
Open LibraryOL375922M
ISBN 101574910787
LC Control Number98037823

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Handbook of Stability Testing in Pharmaceutical Development: Regulations, Methodologies, and Best Practices is the first volume to cover all aspects of stability testing in pharmaceutical development. It presents a scientific understanding of regulations and balances methodologies and best practices.5/5(7). COVID Resources. Reliable information about the coronavirus (COVID) is available from the World Health Organization (current situation, international travel).Numerous and frequently-updated resource results are available from this ’s WebJunction has pulled together information and resources to assist library staff as they consider how to handle coronavirus. Drug Stability for Pharmaceutical Scientists is a clear and easy-to-follow guide on drug degradation in pharmaceutical formulation. This book features valuable content on both aqueous and solid drug solutions, the stability of proteins and peptides, acid-base catalyzed and solvent catalyzed reactions, how drug formulation can influence drug stability, the influence of external factors on. Examining the implications and practical implementation of multi-disciplinary International Conference on Harmonization (ICH) topics, this book gives an integrated view of how the guidelines inform drug development strategic planning and decision-making. Addresses a consistent need for interpretation, training, and implementation examples of ICH guidelines via case studies Offers a primary.

  This handbook is the first to cover all aspects of stability testing in pharmaceutical development. Written by a group of international experts, the book presents a scientific understanding of regulations and balances methodologies and best practices.3/5(4). Data management, including stability reports, CMC, and discussion of out-of-specification (OOS) and out-of-trend (OOT). USP-NF testing in support of stability. Current industry best practices on stability operation, validation, and calibration of stability chambers .   Review of: “The Fundamentals of Stability Testing” (IFSCC Monograph No. 2). International Federation of Societies of Cosmetic Chemists. Micelle Press, Cranford, NJ, pp $ (paper). (ISBN )Author: Paul Becher. Stability testing of pharmaceutical products Article (PDF Available) in Journal of Applied Pharmaceutical Science 2(3) March w Reads How we measure 'reads'.

International Council on Harmonisation - Quality. This guidance is the second revision of Q1A Stability Testing of New Drug Substances and Products, which was first published in September and. This chapter discusses International Conference of Harmonization (ICH) guidelines that are related to the Stability Sciences. It gives a brief history of how the Q1A was initiated. A summary of Q1A(R2) discusses thoroughly the current regulations that the industry supports and by: 4. Handbook of Stability Testing in Pharmaceutical Development: Regulations, Methodologies, and Best Practices is the first volume to cover all aspects of stability testing in pharmaceutical development. It presents a scientific understanding of regulations and balances methodologies and best practices. After introducing the basic concepts of stability testing, the book focuses on short-term stability studies and reviews several methods for estimating drug expiration dating periods. It then compares some commonly employed study designs and discusses both fixed and random batch statistical analyses.