Accelerated Predictive Stability APS

Written By Fenghe Qiu
Accelerated Predictive Stability  APS
  • Publsiher : Academic Press
  • Release : 28 June 2018
  • ISBN : 0128027851
  • Pages : 512 pages
  • Rating : 4/5 from 21 reviews
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Read or download book entitled Accelerated Predictive Stability APS written by Fenghe Qiu which was release on 28 June 2018, this book published by Academic Press. Available in PDF, EPUB and Kindle Format. Book excerpt: Accelerated Predictive Stability (APS): Fundamentals and Pharmaceutical Industry Practices provides coverage of both the fundamental principles and pharmaceutical industry applications of the APS approach. Fundamental chapters explain the scientific basis of the APS approach, while case study chapters from many innovative pharmaceutical companies provide a thorough overview of the current status of APS applications in the pharmaceutical industry. In addition, up-to-date experiences in utilizing APS data for regulatory submissions in many regions and countries highlight the potential of APS in support of registration stability testing for certain regulatory submissions. This book provides high level strategies for the successful implementation of APS in a pharmaceutical company. It offers scientists and regulators a comprehensive resource on how the pharmaceutical industry can enhance their understanding of a product’s stability and predict drug expiry more accurately and quickly. Provides a comprehensive, one-stop-shop resource for accelerated predictive stability (APS) Presents the scientific basis of different APS models Includes the applications and utilities of APS that are demonstrated through numerous case studies Covers up-to-date regulatory experience

Accelerated Predictive Stability APS

Accelerated Predictive Stability  APS
  • Author : Fenghe Qiu,Garry Scrivens
  • Publisher : Academic Press
  • Release Date : 2018-06-28
  • Total pages : 512
  • ISBN : 0128027851
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Summary : Accelerated Predictive Stability (APS): Fundamentals and Pharmaceutical Industry Practices provides coverage of both the fundamental principles and pharmaceutical industry applications of the APS approach. Fundamental chapters explain the scientific basis of the APS approach, while case study chapters from many innovative pharmaceutical companies provide a thorough overview of the current ...

Analytical Scientists in Pharmaceutical Product Development

Analytical Scientists in Pharmaceutical Product Development
  • Author : Kangping Xiao
  • Publisher : John Wiley & Sons
  • Release Date : 2020-10-06
  • Total pages : 272
  • ISBN : 0128027851
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Summary : This book explains task management concepts and outlines practical knowledge to help pharmaceutical analytical scientists become productive and enhance their career. •Presents broad topics such as product development process, regulatory requirement, task and project management, innovation mindset, molecular recognition, separation science, degradation chemistry, and statistics. •Provokes thinking through figures, tables, ...

Specialised Pharmaceutical Formulation

Specialised Pharmaceutical Formulation
  • Author : Geoffrey D. Tovey
  • Publisher : Royal Society of Chemistry
  • Release Date : 2022-05-04
  • Total pages : 338
  • ISBN : 0128027851
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Summary : Specialised Pharmaceutical Formulation is an essential, up to date resource and will equip readers with the ability to effectively and reliably produce products intended for less common and novel routes of administration which can be approved, manufactured and made available to administer to patients....

Dosage Form Design Considerations

Dosage Form Design Considerations
  • Author : Anonim
  • Publisher : Academic Press
  • Release Date : 2018-07-28
  • Total pages : 820
  • ISBN : 0128027851
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Summary : 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 ...

Statistical Applications for Chemistry Manufacturing and Controls CMC in the Pharmaceutical Industry

Statistical Applications for Chemistry  Manufacturing and Controls  CMC  in the Pharmaceutical Industry
  • Author : Richard K. Burdick,David J. LeBlond,Lori B. Pfahler,Jorge Quiroz,Leslie Sidor,Kimberly Vukovinsky,Lanju Zhang
  • Publisher : Springer
  • Release Date : 2017-02-14
  • Total pages : 379
  • ISBN : 0128027851
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Summary : This book examines statistical techniques that are critically important to Chemistry, Manufacturing, and Control (CMC) activities. Statistical methods are presented with a focus on applications unique to the CMC in the pharmaceutical industry. The target audience consists of statisticians and other scientists who are responsible for performing statistical analyses within ...

Energy Research Abstracts

Energy Research Abstracts
  • Author : Anonim
  • Publisher : Unknown
  • Release Date : 1993
  • Total pages : 212
  • ISBN : 0128027851
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Summary : Download or read online Energy Research Abstracts written by , published by which was released on 1993. Get Energy Research Abstracts Books now! Available in PDF, ePub and Kindle....

Methanol Fuel Modification for Highway Vehicle Use

Methanol Fuel Modification for Highway Vehicle Use
  • Author : J. L. Keller,G. M. Nakaguchi,J. C. Ware
  • Publisher : Unknown
  • Release Date : 1978
  • Total pages : 430
  • ISBN : 0128027851
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Summary : Download or read online Methanol Fuel Modification for Highway Vehicle Use written by J. L. Keller,G. M. Nakaguchi,J. C. Ware, published by which was released on 1978. Get Methanol Fuel Modification for Highway Vehicle Use Books now! Available in PDF, ePub and Kindle....

Rheological Properties of Cosmetics and Toiletries

Rheological Properties of Cosmetics and Toiletries
  • Author : Dennis Laba
  • Publisher : Routledge
  • Release Date : 2017-09-18
  • Total pages : 440
  • ISBN : 0128027851
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Summary : This volume in the Cosmetic Science and Technology series covers the important rheological aspects of cosmetic and toiletry formulations, including theoretical physical chemistry, instrumentation and measuring techniques, raw materials and stability predictions. The work discusses the specific rheological requirements of nail polish, antipersirants and deodorants, dentifrices, hair care products, creams ...

Pharmaceutical Industry Practices on Genotoxic Impurities

Pharmaceutical Industry Practices on Genotoxic Impurities
  • Author : Heewon Lee
  • Publisher : CRC Press
  • Release Date : 2014-08-29
  • Total pages : 536
  • ISBN : 0128027851
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Summary : A great deal of confusion and uncertainty over genotoxic impurity (GTI) identification, assessment, and control exists in the pharmaceutical industry today. Pharmaceutical Industry Practices on Genotoxic Impurities strives to facilitate scientific and systematic consensus on GTI management by presenting rationales, strategies, methods, interpretati...

Bulletin

Bulletin
  • Author : United States. Bureau of Mines
  • Publisher : Unknown
  • Release Date : 1971
  • Total pages : 212
  • ISBN : 0128027851
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Summary : Download or read online Bulletin written by United States. Bureau of Mines, published by which was released on 1971. Get Bulletin Books now! Available in PDF, ePub and Kindle....

Bulletin

Bulletin
  • Author : Anonim
  • Publisher : Unknown
  • Release Date : 2022-06-25
  • Total pages : 212
  • ISBN : 0128027851
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Summary : Download or read online Bulletin written by , published by which was released on . Get Bulletin Books now! Available in PDF, ePub and Kindle....

Distributed Model Predictive Control Made Easy

Distributed Model Predictive Control Made Easy
  • Author : José M. Maestre,Rudy R. Negenborn
  • Publisher : Springer Science & Business Media
  • Release Date : 2013-11-10
  • Total pages : 600
  • ISBN : 0128027851
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Summary : The rapid evolution of computer science, communication, and information technology has enabled the application of control techniques to systems beyond the possibilities of control theory just a decade ago. Critical infrastructures such as electricity, water, traffic and intermodal transport networks are now in the scope of control engineers. The sheer ...

Combination Vaccines

Combination Vaccines
  • Author : Ronald W. Ellis
  • Publisher : Springer Science & Business Media
  • Release Date : 1999-05-25
  • Total pages : 279
  • ISBN : 0128027851
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Summary : A diverse team of leading experts comprehensively review the complex biology of a wide variety of vaccine combinations, as well as the technical, clinical, and regulatory aspects of their development. Topics covered range from the use of immunological correlates of efficacy, rather than efficacy per se, for the evaluation and ...

Handbook of Analysis of Edible Animal By Products

Handbook of Analysis of Edible Animal By Products
  • Author : Leo M.L. Nollet,Fidel Toldra
  • Publisher : CRC Press
  • Release Date : 2011-04-01
  • Total pages : 472
  • ISBN : 0128027851
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Summary : Considered high-priced delicacies or waste material to be tossed away, the use and value of offal-edible and inedible animal by-products-depend entirely on the culture and country in question. The skin, blood, bones, meat trimmings, fatty tissues, horns, hoofs, feet, skull, and entrails of butchered animals comprise a wide variety of ...

Industrial Aspects of Pharmecuticals

Industrial Aspects of Pharmecuticals
  • Author : SANDELL
  • Publisher : CRC Press
  • Release Date : 1992-06-01
  • Total pages : 298
  • ISBN : 0128027851
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Summary : Download or read online Industrial Aspects of Pharmecuticals written by SANDELL, published by CRC Press which was released on 1992-06-01. Get Industrial Aspects of Pharmecuticals Books now! Available in PDF, ePub and Kindle....