Statistical Design and Analysis of Stability Studies PDF Download

Author: Shein-Chung Chow
Publisher: CRC Press
ISBN: 1584889063
Category : Mathematics
Languages : en
Pages : 351

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Book Description
The US Food and Drug Administration's Report to the Nation in 2004 and 2005 indicated that one of the top reasons for drug recall was that stability data did not support existing expiration dates. Pharmaceutical companies conduct stability studies to characterize the degradation of drug products and to estimate drug shelf life. Illustrating how sta

Author: Kim Huynh-Ba
Publisher: Springer Science & Business Media
ISBN: 0387856277
Category : Medical
Languages : en
Pages : 389

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Book Description
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.

Author:
Publisher: Academic Press
ISBN: 0128144246
Category : Medical
Languages : en
Pages : 820

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Book Description
Dosage Form Design Parameters, Volume I, examines the history and current state of the field within the pharmaceutical sciences, presenting key developments. Content includes drug development issues, the scale up of formulations, regulatory issues, intellectual property, solid state properties and polymorphism. Written by experts in the field, this volume in the Advances in Pharmaceutical Product Development and Research series deepens our understanding of dosage form design parameters. Chapters delve into a particular aspect of this fundamental field, covering principles, methodologies and the technologies employed by pharmaceutical scientists. In addition, the book contains a comprehensive examination suitable for researchers and advanced students working in pharmaceuticals, cosmetics, biotechnology and related industries. Examines the history and recent developments in drug dosage forms for pharmaceutical sciences Focuses on physicochemical aspects, prefomulation solid state properties and polymorphism Contains extensive references for further discovery and learning that are appropriate for advanced undergraduates, graduate students and those interested in drug dosage design

Author: Shayne Cox Gad
Publisher: John Wiley & Sons
ISBN: 0470259825
Category : Science
Languages : en
Pages : 857

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Book Description
With its coverage of Food and Drug Administration regulations, international regulations, good manufacturing practices, and process analytical technology, this handbook offers complete coverage of the regulations and quality control issues that govern pharmaceutical manufacturing. In addition, the book discusses quality assurance and validation, drug stability, and contamination control, all key aspects of pharmaceutical manufacturing that are heavily influenced by regulatory guidelines. The team of expert authors offer you advice based on their own firsthand experience in all phases of pharmaceutical manufacturing.

Author: Sarfaraz K. Niazi
Publisher: CRC Press
ISBN: 1420081241
Category : Medical
Languages : en
Pages : 400

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Book Description
While liquid drugs do not share the compression problems of solid dosage forms, the filling problems of powder dosage forms, or the consistency problems of semisolid dosage forms, they do have their own set of considerations in the formulation and manufacturing stages.Highlights from Liquid Products, Volume Three include:practical details invo

Author: Sarfaraz K. Niazi
Publisher: CRC Press
ISBN: 1351593501
Category : Medical
Languages : en
Pages : 551

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Book Description
The Handbook of Pharmaceutical Manufacturing Formulations, Third Edition: Volume Three, Liquid Products is an authoritative and practical guide to the art and science of formulating drugs for commercial manufacturing. With thoroughly revised and expanded content, this third volume of a six-volume set, compiles data from FDA and EMA new drug applications, patents and patent applications, and other sources of generic and proprietary formulations including author’s own experience, to cover the broad spectrum of cGMP formulations and issues in using these formulations in a commercial setting. A must-have collection for pharmaceutical manufacturers, educational institutions, and regulatory authorities, this is an excellent platform for drug companies to benchmark their products and for generic companies to formulate drugs coming off patent. Features:  Largest source of authoritative and practical formulations, cGMP compliance guidance and self-audit suggestions  Differs from other publications on formulation science in that it focuses on readily scalable commercial formulations that can be adopted for cGMP manufacturing  Tackles common difficulties in formulating drugs and presents details on stability testing, bioequivalence testing, and full compliance with drug product safety elements  Written by a well-recognized authority on drug and dosage form development including biological drugs and alternative medicines

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Publisher: John Wiley & Sons
ISBN: 0471744069
Category : Mathematics
Languages : en
Pages : 562

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Book Description
ENCYCLOPEDIA OF STATISTICAL SCIENCES

Author: Kim Huynh-Ba
Publisher: Springer Science & Business Media
ISBN: 1441908897
Category : Medical
Languages : en
Pages : 261

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Book Description
The International Conference of Harmonization (ICH) has worked on har- nizing the stability regulations in the US, Europe, and Japan since the early 1990s. Even though the Stability Guidelines Q1A (R2) was issued over a decade ago, issues surrounding this arena continue to surface as the principles described in the guideline are applied to different technical concentrations. As a result, the stability community has continued to discuss concerns and find ways of harmonizing regulatory requirements, streamlining practices, improving processes in order to bring safe and effective medical supplies to the patients around the world. In 2007, the American Association of Pharmaceutical Scientists (AAPS) Stability Focus Group organized two workshops – the Stability Workshop and the Degradation Mechanism Workshop. These meetings attracted many industry scientists as well as representatives from several regulatory agencies in the world to discuss important topics related to pharmaceutical stability practices. Recognizing the importance of documenting these discussions and with the permission of AAPS, I have worked with speakers to assemble a collection of 30 articles from presentations given at these two meetings, mainly the Stability Workshop. I trust that this book will be beneficial to all of you in providing guidance and up-to-date information for building quality stability programs. v Freedom of our mind is Mother of all inventions.

Author: Shein-Chung Chow
Publisher: CRC Press
ISBN: 1482273136
Category : Mathematics
Languages : en
Pages : 581

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Book Description
"Offers a comprehensive, unified presentation of statistical designs and methods of analysis for all stages of pharmaceutical development--emphasizing biopharmaceutical applications and demonstrating statistical techniques with real-world examples."

Author: Vinay Bhatt
Publisher: CRC Press
ISBN: 9781574910773
Category : Medical
Languages : en
Pages : 528

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Book Description
Written by twenty-eight experts, filled with recommendations that can immediately be put into action, this book provides the strategies and tactics required to link and harmonize manufacturing processes with GMP to achieve optimum operability and cost-effective regulatory compliance. Drawn from name brand and generic companies and regulatory and contract organizations across the globe, the contributing authors bring readers a combined 450+ years of hands-on experience. They offer thought-provoking questions to help readers diagnose their company's challenges, needs, and available options, all with the single purpose of achieving their ultimate goals: quality, high productivity, and profitability.