Statistical Design and Analysis of Stability Studies PDF Download
Are you looking for read ebook online? Search for your book and save it on your Kindle device, PC, phones or tablets. Download Statistical Design and Analysis of Stability Studies PDF full book. Access full book title Statistical Design and Analysis of Stability Studies by Shein-Chung Chow. Download full books in PDF and EPUB format.
Author: Shein-Chung Chow
Publisher: CRC Press
ISBN: 1584889063
Category : Mathematics
Languages : en
Pages : 351
Get Book Here
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: Shein-Chung Chow
Publisher: CRC Press
ISBN: 1584889063
Category : Mathematics
Languages : en
Pages : 351
Get Book Here
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
Get Book Here
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 : 881
Get Book Here
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: Sarfaraz K. Niazi
Publisher: CRC Press
ISBN: 1351593501
Category : Medical
Languages : en
Pages : 580
Get Book Here
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
Author:
Publisher: John Wiley & Sons
ISBN: 0471744069
Category : Mathematics
Languages : en
Pages : 562
Get Book Here
Book Description
ENCYCLOPEDIA OF STATISTICAL SCIENCES
Author: John Arnold
Publisher: John Wiley & Sons
ISBN: 0470173416
Category : Science
Languages : en
Pages : 643
Get Book Here
Book Description
The only single, comprehensive textbook on all aspects of digital television The next few years will see a major revolution in the technology used to deliver television services as the world moves from analog to digital television. Presently, all existing textbooks dealing with analog television standards (NTSC and PAL) are becoming obsolete as the prevalence of digital technology continues to become more widespread. Now, Digital Television: Technology and Standards fills the need for a single, authoritative textbook that covers all aspects of digital television technology. Divided into three main sections, Digital Television explores: * Video: MPEG-2, which is at the heart of all digital video broadcasting services * Audio: MPEG-2 Advanced Audio Coding and Dolby AC-3, which will be used internationally in digital video broadcasting systems * Systems: MPEG, modulation transmission, forward error correction, datacasting, conditional access, and digital storage media command and control Complete with tables, illustrations, and figures, this valuable textbook includes problems and laboratories at the end of each chapter and also offers a number of exercises that allow students to implement the various techniques discussed using MATLAB. The authors' coverage of implementation and theory makes this a practical reference for professionals, as well as an indispensable textbook for advanced undergraduates and graduate-level students in electrical engineering and computer science programs.
Author: Shayne Cox Gad
Publisher: John Wiley & Sons
ISBN: 0470259825
Category : Science
Languages : en
Pages : 857
Get Book Here
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:
Publisher: New Age International
ISBN: 9788122413601
Category :
Languages : en
Pages : 726
Get Book Here
Book Description
Author: Kim Huynh-Ba
Publisher: Springer Science & Business Media
ISBN: 1441908897
Category : Medical
Languages : en
Pages : 261
Get Book Here
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: Sarfaraz K. Niazi
Publisher: CRC Press
ISBN: 1420081241
Category : Medical
Languages : en
Pages : 400
Get Book Here
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
