Accelerated Predictive Stability APS

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

Produk Detail:

  • Author : Fenghe Qiu
  • Publisher : Academic Press
  • Pages : 512 pages
  • ISBN : 0128027851
  • Rating : 4/5 from 21 reviews
CLICK HERE TO GET THIS BOOKAccelerated Predictive Stability APS

Accelerated Predictive Stability (APS)

Accelerated Predictive Stability (APS)
  • Author : Fenghe Qiu,Garry Scrivens
  • Publisher : Academic Press
  • Release : 28 June 2018
GET THIS BOOKAccelerated Predictive Stability (APS)

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

Methods for Stability Testing of Pharmaceuticals

Methods for Stability Testing of Pharmaceuticals
  • Author : Sanjay Bajaj,Saranjit Singh
  • Publisher : Humana
  • Release : 08 June 2019
GET THIS BOOKMethods for Stability Testing of Pharmaceuticals

This detailed volume collects numerous methods and protocols related to different aspects of stability programs that are followed in pharmaceutical development laboratories. Implementation of a successful stability program, vital in preventing product failures and recalls, requires critical and logical thinking that goes beyond the regular documented protocols and methods, so the experiences of the book’s internationally-based expert contributors fill the chapters with practical guidance. As a volume in the Methods in Pharmacology and Toxicology series, this book presents the

Drug Stability for Pharmaceutical Scientists

Drug Stability for Pharmaceutical Scientists
  • Author : Thorsteinn Loftsson
  • Publisher : Academic Press
  • Release : 25 January 2014
GET THIS BOOKDrug Stability for Pharmaceutical Scientists

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 reaction rates and much more. Full of examples of real-life formulation problems and step-by-step calculations, this book is the ideal resource for graduate students, as well

Food and Beverage Stability and Shelf Life

Food and Beverage Stability and Shelf Life
  • Author : David Kilcast,Persis Subramaniam
  • Publisher : Elsevier
  • Release : 08 April 2011
GET THIS BOOKFood and Beverage Stability and Shelf Life

Ensuring that foods and beverages remain stable during the required shelf life is critical to their success in the market place, yet companies experience difficulties in this area. Food and beverage stability and shelf life provides a comprehensive guide to factors influencing stability, methods of stability and shelf life assessment and the stability and shelf life of major products. Part one describes important food and beverage quality deterioration processes, including microbiological spoilage and physical instability. Chapters in this section also

Accelerated Aging

Accelerated Aging
  • Author : Robert L. Feller
  • Publisher : Getty Publications
  • Release : 02 March 1995
GET THIS BOOKAccelerated Aging

Accelerated Aging: Photochemical and Thermal Aspects represents the culmination of more than 40 years of research by noted scientist Robert L. Feller. The book focuses on the long-term performance of materials such as wool, dyes, and organic compounds; their resistance to change when exposed to environmental factors such as oxygen, ozone, moisture, heat, and light; and their physical durability with handling and use over time. Processes of deterioration are discussed based on speeded-up laboratory studies designed to clarify the chemical reactions

Statistical Design and Analysis of Stability Studies

Statistical Design and Analysis of Stability Studies
  • Author : Shein-Chung Chow
  • Publisher : CRC Press
  • Release : 30 May 2007
GET THIS BOOKStatistical Design and Analysis of Stability Studies

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 stability studies play an important role in drug safety and quality assurance, Statistical Design and Analysis of Stability Studies presents the principles and methodologies in the design and

Improving and Accelerating Therapeutic Development for Nervous System Disorders

Improving and Accelerating Therapeutic Development for Nervous System Disorders
  • Author : Institute of Medicine,Board on Health Sciences Policy,Forum on Neuroscience and Nervous System Disorders
  • Publisher : National Academies Press
  • Release : 06 February 2014
GET THIS BOOKImproving and Accelerating Therapeutic Development for Nervous System Disorders

Improving and Accelerating Therapeutic Development for Nervous System Disorders is the summary of a workshop convened by the IOM Forum on Neuroscience and Nervous System Disorders to examine opportunities to accelerate early phases of drug development for nervous system drug discovery. Workshop participants discussed challenges in neuroscience research for enabling faster entry of potential treatments into first-in-human trials, explored how new and emerging tools and technologies may improve the efficiency of research, and considered mechanisms to facilitate a more effective

Pharmaceutical Stress Testing

Pharmaceutical Stress Testing
  • Author : Steven W. Baertschi,Karen M. Alsante,Robert A. Reed
  • Publisher : CRC Press
  • Release : 24 June 2005
GET THIS BOOKPharmaceutical Stress Testing

The first book devoted to the topic, this reference discusses the predictive power and limitations of current stress testing strategies and emphasizes the critical role of stress testing in the determination of the stability characteristics of pharmaceuticals-offering an extensive compilation of drug degradation studies from real-world examples in the literature.

Continuous Manufacturing for the Modernization of Pharmaceutical Production

Continuous Manufacturing for the Modernization of Pharmaceutical Production
  • Author : National Academies of Sciences, Engineering, and Medicine,Division on Earth and Life Studies,Board on Chemical Sciences and Technology
  • Publisher : National Academies Press
  • Release : 05 April 2019
GET THIS BOOKContinuous Manufacturing for the Modernization of Pharmaceutical Production

On July 30-31, 2018, the National Academies of Sciences, Engineering, and Medicine held a workshop titled Continuous Manufacturing for the Modernization of Pharmaceutical Production. This workshop discussed the business and regulatory concerns associated with adopting continuous manufacturing techniques to produce biologics such as enzymes, monoclonal antibodies, and vaccines. The participants also discussed specific challenges for integration across the manufacturing system, including upstream and downstream processes, analytical techniques, and drug product development. The workshop addressed these challenges broadly across the biologics domain

Rare Diseases and Orphan Products

Rare Diseases and Orphan Products
  • Author : Institute of Medicine,Board on Health Sciences Policy,Committee on Accelerating Rare Diseases Research and Orphan Product Development
  • Publisher : National Academies Press
  • Release : 03 April 2011
GET THIS BOOKRare Diseases and Orphan Products

Rare diseases collectively affect millions of Americans of all ages, but developing drugs and medical devices to prevent, diagnose, and treat these conditions is challenging. The Institute of Medicine (IOM) recommends implementing an integrated national strategy to promote rare diseases research and product development.

Synthetic Methods in Drug Discovery

Synthetic Methods in Drug Discovery
  • Author : David C Blakemore,Paul M Doyle,Yvette M Fobian
  • Publisher : Royal Society of Chemistry
  • Release : 15 July 2016
GET THIS BOOKSynthetic Methods in Drug Discovery

Synthetic Methods in Drug Discovery Volume 1 focusses on the hugely important area of transition metal mediated methods used in industry. Current methods of importance such as the Suzuki-Miyaura coupling, Buchwald-Hartwig couplings and CH activation are discussed. In addition, exciting emerging areas such as decarboxylative coupling, and the uses of iron and nickel in coupling reactions are also covered. This book provides both academic and industrial perspectives on some key reactions giving the reader an excellent overview of the techniques used

World Economic Situation and Prospects 2020

World Economic Situation and Prospects 2020
  • Author : United Nations
  • Publisher : United Nations
  • Release : 16 January 2020
GET THIS BOOKWorld Economic Situation and Prospects 2020

This is the United Nations definitive report on the state of the world economy, providing global and regional economic outlook for 2020 and 2021. Produced by the Department of Economic and Social Affairs, the five United Nations regional commissions, the United Nations Conference on Trade and Development, with contributions from the UN World Tourism Organization and other intergovernmental agencies.

Musculoskeletal Disorders and the Workplace

Musculoskeletal Disorders and the Workplace
  • Author : National Research Council,Division of Behavioral and Social Sciences and Education,Institute of Medicine,Board on Human-Systems Integration,Commission on Behavioral and Social Sciences and Education,Panel on Musculoskeletal Disorders and the Workplace
  • Publisher : National Academies Press
  • Release : 24 June 2001
GET THIS BOOKMusculoskeletal Disorders and the Workplace

Every year workers' low-back, hand, and arm problems lead to time away from jobs and reduce the nation's economic productivity. The connection of these problems to workplace activities-from carrying boxes to lifting patients to pounding computer keyboards-is the subject of major disagreements among workers, employers, advocacy groups, and researchers. Musculoskeletal Disorders and the Workplace examines the scientific basis for connecting musculoskeletal disorders with the workplace, considering people, job tasks, and work environments. A multidisciplinary panel draws conclusions about the likelihood

Accelerate

Accelerate
  • Author : Nicole Forsgren PhD,Jez Humble,Gene Kim
  • Publisher : IT Revolution
  • Release : 27 March 2018
GET THIS BOOKAccelerate

Winner of the Shingo Publication Award Accelerate your organization to win in the marketplace. How can we apply technology to drive business value? For years, we've been told that the performance of software delivery teams doesn't matter―that it can't provide a competitive advantage to our companies. Through four years of groundbreaking research to include data collected from the State of DevOps reports conducted with Puppet, Dr. Nicole Forsgren, Jez Humble, and Gene Kim set out to find a way