Author: Yashwant V. Pathak
Publisher: Springer
ISBN: 9783030055257
Category : Medical
Languages : en
Pages : 0
Book Description
This handbook, directed at medical professionals and students who are involved in developing the space industry or are academicians doing research in this area, covers current pharmaceutical knowledge about the difference in medication efficacy in space versus on Earth and includes trial results and best practices for the space research and travel industry. The well-known contributors come from an interdisciplinary background and address all aspects of the subject, from the physiological impact of spaceflight to the effects of radiation. As the commercial space industry expands its operations in industry and tourism, the field of space pharmaceuticals is growing commensurately. Existing pharmacological research from space is thoroughly covered in this book, and Earth applications are also described. Potential pharmacological solutions are posed along with the known challenges and examples from existing studies, which are detailed at length. This major reference work is a comprehensive and important medical resource for all space industry players.
Handbook of Space Pharmaceuticals
Author: Yashwant V. Pathak
Publisher: Springer
ISBN: 9783030055257
Category : Medical
Languages : en
Pages : 0
Book Description
This handbook, directed at medical professionals and students who are involved in developing the space industry or are academicians doing research in this area, covers current pharmaceutical knowledge about the difference in medication efficacy in space versus on Earth and includes trial results and best practices for the space research and travel industry. The well-known contributors come from an interdisciplinary background and address all aspects of the subject, from the physiological impact of spaceflight to the effects of radiation. As the commercial space industry expands its operations in industry and tourism, the field of space pharmaceuticals is growing commensurately. Existing pharmacological research from space is thoroughly covered in this book, and Earth applications are also described. Potential pharmacological solutions are posed along with the known challenges and examples from existing studies, which are detailed at length. This major reference work is a comprehensive and important medical resource for all space industry players.
Publisher: Springer
ISBN: 9783030055257
Category : Medical
Languages : en
Pages : 0
Book Description
This handbook, directed at medical professionals and students who are involved in developing the space industry or are academicians doing research in this area, covers current pharmaceutical knowledge about the difference in medication efficacy in space versus on Earth and includes trial results and best practices for the space research and travel industry. The well-known contributors come from an interdisciplinary background and address all aspects of the subject, from the physiological impact of spaceflight to the effects of radiation. As the commercial space industry expands its operations in industry and tourism, the field of space pharmaceuticals is growing commensurately. Existing pharmacological research from space is thoroughly covered in this book, and Earth applications are also described. Potential pharmacological solutions are posed along with the known challenges and examples from existing studies, which are detailed at length. This major reference work is a comprehensive and important medical resource for all space industry players.
Space Pharmacology
Author: Virginia E. Wotring
Publisher: Springer Science & Business Media
ISBN: 1461433959
Category : Science
Languages : en
Pages : 119
Book Description
“Space Pharmacology” is a review of the current knowledge regarding the use of pharmaceuticals during spaceflights. It is a comprehensive review of the literature, addressing each area of pharmacokinetics and each major physiological system in turn. Every section begins with a topic overview, and is followed by a discussion of published data from spaceflight, and from ground experiments meant to model the spaceflight situation. Includes a discussion looking forward to the new medical challenges we are likely to face on longer duration exploration missions. This book is a snapshot of our current knowledge that also highlights areas of unknown.
Publisher: Springer Science & Business Media
ISBN: 1461433959
Category : Science
Languages : en
Pages : 119
Book Description
“Space Pharmacology” is a review of the current knowledge regarding the use of pharmaceuticals during spaceflights. It is a comprehensive review of the literature, addressing each area of pharmacokinetics and each major physiological system in turn. Every section begins with a topic overview, and is followed by a discussion of published data from spaceflight, and from ground experiments meant to model the spaceflight situation. Includes a discussion looking forward to the new medical challenges we are likely to face on longer duration exploration missions. This book is a snapshot of our current knowledge that also highlights areas of unknown.
Handbook of Modern Pharmaceutical Analysis
Author: Satinder Ahuja
Publisher: Academic Press
ISBN: 0123759811
Category : Medical
Languages : en
Pages : 604
Book Description
Handbook of Modern Pharmaceutical Analysis, Second Edition, synthesizes the complex research and recent changes in the field, while covering the techniques and technology required for today's laboratories. The work integrates strategy, case studies, methodologies, and implications of new regulatory structures, providing complete coverage of quality assurance from the point of discovery to the point of use. - Treats pharmaceutical analysis (PA) as an integral partner to the drug development process rather than as a service to it - Covers method development, validation, selection, testing, modeling, and simulation studies combined with advanced exploration of assays, impurity testing, biomolecules, and chiral separations - Features detailed coverage of QA, ethics, and regulatory guidance (quality by design, good manufacturing practice), as well as high-tech methodologies and technologies from "lab-on-a-chip" to LC-MS, LC-NMR, and LC-NMR-MS
Publisher: Academic Press
ISBN: 0123759811
Category : Medical
Languages : en
Pages : 604
Book Description
Handbook of Modern Pharmaceutical Analysis, Second Edition, synthesizes the complex research and recent changes in the field, while covering the techniques and technology required for today's laboratories. The work integrates strategy, case studies, methodologies, and implications of new regulatory structures, providing complete coverage of quality assurance from the point of discovery to the point of use. - Treats pharmaceutical analysis (PA) as an integral partner to the drug development process rather than as a service to it - Covers method development, validation, selection, testing, modeling, and simulation studies combined with advanced exploration of assays, impurity testing, biomolecules, and chiral separations - Features detailed coverage of QA, ethics, and regulatory guidance (quality by design, good manufacturing practice), as well as high-tech methodologies and technologies from "lab-on-a-chip" to LC-MS, LC-NMR, and LC-NMR-MS
Handbook of Isolation and Characterization of Impurities in Pharmaceuticals
Author: Satinder Ahuja
Publisher: Elsevier
ISBN: 008050776X
Category : Medical
Languages : en
Pages : 432
Book Description
The United States Food and Drug Administration (FDA) and other regulatory bodies around the world require that impurities in drug substance and drug product levels recommended by the International Conference on Harmonisation (ICH) be isolated and characterized. Identifying process-related impurities and degradation products also helps us to understand the production of impurities and assists in defining degradation mechanisms. When this process is performed at an early stage, there is ample time to address various aspects of drug development to prevent or control the production of impurities and degradation products well before the regulatory filing and thus assure production of a high-quality drug product.This book, therefore, has been designed to meet the need for a reference text on the complex process of isolation and characterization of process-related (synthesis and formulation) impurities and degradation products to meet critical requlatory requirements.It's objective is to provide guidance on isolating and characterizing impurities of pharmaceuticals such as drug candidates, drug substances, and drug products. The book outlines impurity identification processes and will be a key resource document for impurity analysis, isolation/synthesis, and characterization.- Provides valuable information on isolation and characterization of impurities. - Gives a regulatory perspective on the subject. - Describes various considerations involved in meeting regulatory requirements. - Discusses various sources of impurities and degredation products.
Publisher: Elsevier
ISBN: 008050776X
Category : Medical
Languages : en
Pages : 432
Book Description
The United States Food and Drug Administration (FDA) and other regulatory bodies around the world require that impurities in drug substance and drug product levels recommended by the International Conference on Harmonisation (ICH) be isolated and characterized. Identifying process-related impurities and degradation products also helps us to understand the production of impurities and assists in defining degradation mechanisms. When this process is performed at an early stage, there is ample time to address various aspects of drug development to prevent or control the production of impurities and degradation products well before the regulatory filing and thus assure production of a high-quality drug product.This book, therefore, has been designed to meet the need for a reference text on the complex process of isolation and characterization of process-related (synthesis and formulation) impurities and degradation products to meet critical requlatory requirements.It's objective is to provide guidance on isolating and characterizing impurities of pharmaceuticals such as drug candidates, drug substances, and drug products. The book outlines impurity identification processes and will be a key resource document for impurity analysis, isolation/synthesis, and characterization.- Provides valuable information on isolation and characterization of impurities. - Gives a regulatory perspective on the subject. - Describes various considerations involved in meeting regulatory requirements. - Discusses various sources of impurities and degredation products.
Handbook of Pharmaceutical Wet Granulation
Author: Ajit S. Narang
Publisher: Academic Press
ISBN: 0323481035
Category : Medical
Languages : en
Pages : 894
Book Description
Handbook of Pharmaceutical Wet Granulation: Theory and Practice in a Quality by Design Paradigm offers a single and comprehensive reference dedicated to all aspects of pharmaceutical wet granulation, taking a holistic approach by combining introductory principles with practical solutions. Chapters are written by international experts across industry, academic and regulatory settings, and cover a wide spectrum of relevant and contemporary wet granulation topics, techniques and processes. The books' focus on process analytical technology, quality by design principles, granulation equipment, modeling, scale-up, control and real time release makes it a timely and valuable resource for all those involved in pharmaceutical wet granulation. - Discusses fundamentals of theory and current industrial practice in the field of wet granulation, including product and process design and role of material properties in wet granulation - Examines the modern evolution of wet granulation through current topics such as established and novel process analytical technologies (PATs), and product development and scale-up paradigms - Written for scientists working within the pharmaceutical industry, as well as academics, regulatory officials and equipment vendors who provide PAT tools and granulation equipment
Publisher: Academic Press
ISBN: 0323481035
Category : Medical
Languages : en
Pages : 894
Book Description
Handbook of Pharmaceutical Wet Granulation: Theory and Practice in a Quality by Design Paradigm offers a single and comprehensive reference dedicated to all aspects of pharmaceutical wet granulation, taking a holistic approach by combining introductory principles with practical solutions. Chapters are written by international experts across industry, academic and regulatory settings, and cover a wide spectrum of relevant and contemporary wet granulation topics, techniques and processes. The books' focus on process analytical technology, quality by design principles, granulation equipment, modeling, scale-up, control and real time release makes it a timely and valuable resource for all those involved in pharmaceutical wet granulation. - Discusses fundamentals of theory and current industrial practice in the field of wet granulation, including product and process design and role of material properties in wet granulation - Examines the modern evolution of wet granulation through current topics such as established and novel process analytical technologies (PATs), and product development and scale-up paradigms - Written for scientists working within the pharmaceutical industry, as well as academics, regulatory officials and equipment vendors who provide PAT tools and granulation equipment
In-Space Manufacturing and Resources
Author: Volker Hessel
Publisher: John Wiley & Sons
ISBN: 352783091X
Category : Technology & Engineering
Languages : en
Pages : 436
Book Description
Comprehensive resource covering all in-space manufacturing and planetary resource exploration endeavors. The space economy is developing quickly, and pivotal events have brought us to a strong inflection point. This unique book includes fundamental and ground-breaking innovations in the field and is meant to quickly get readers up to speed on many different facets of space and planetary resource exploration, such as: Space health & medicine Space biology & space farming Space chemistry & space mining Space construction & advanced materials production Space policy, law & economics Presenting a snapshot of the expanding space economy and manufacturing applications in low-Earth orbit, along with resource utilization capabilities in development for Moon and Mars missions, this an indispensable source for all researchers and commercial companies working on space and planetary resource exploration.
Publisher: John Wiley & Sons
ISBN: 352783091X
Category : Technology & Engineering
Languages : en
Pages : 436
Book Description
Comprehensive resource covering all in-space manufacturing and planetary resource exploration endeavors. The space economy is developing quickly, and pivotal events have brought us to a strong inflection point. This unique book includes fundamental and ground-breaking innovations in the field and is meant to quickly get readers up to speed on many different facets of space and planetary resource exploration, such as: Space health & medicine Space biology & space farming Space chemistry & space mining Space construction & advanced materials production Space policy, law & economics Presenting a snapshot of the expanding space economy and manufacturing applications in low-Earth orbit, along with resource utilization capabilities in development for Moon and Mars missions, this an indispensable source for all researchers and commercial companies working on space and planetary resource exploration.
Pharmaceutical Industry Antitrust Handbook
Author:
Publisher: American Bar Association
ISBN: 9781604425628
Category : Antitrust law
Languages : en
Pages : 484
Book Description
Publisher: American Bar Association
ISBN: 9781604425628
Category : Antitrust law
Languages : en
Pages : 484
Book Description
Handbook of Pharmaceutical Analysis by HPLC
Author: Satinder Ahuja
Publisher: Elsevier
ISBN: 0080455182
Category : Medical
Languages : en
Pages : 679
Book Description
High pressure liquid chromatography–frequently called high performance liquid chromatography (HPLC or, LC) is the premier analytical technique in pharmaceutical analysis and is predominantly used in the pharmaceutical industry. Written by selected experts in their respective fields, the Handbook of Pharmaceutical Analysis by HPLC Volume 6, provides a complete yet concise reference guide for utilizing the versatility of HPLC in drug development and quality control. Highlighting novel approaches in HPLC and the latest developments in hyphenated techniques, the book captures the essence of major pharmaceutical applications (assays, stability testing, impurity testing, dissolution testing, cleaning validation, high-throughput screening). A complete reference guide to HPLC Describes best practices in HPLC and offers 'tricks of the trade' in HPLC operation and method development Reviews key HPLC pharmaceutical applications and highlights currents trends in HPLC ancillary techniques, sample preparations, and data handling
Publisher: Elsevier
ISBN: 0080455182
Category : Medical
Languages : en
Pages : 679
Book Description
High pressure liquid chromatography–frequently called high performance liquid chromatography (HPLC or, LC) is the premier analytical technique in pharmaceutical analysis and is predominantly used in the pharmaceutical industry. Written by selected experts in their respective fields, the Handbook of Pharmaceutical Analysis by HPLC Volume 6, provides a complete yet concise reference guide for utilizing the versatility of HPLC in drug development and quality control. Highlighting novel approaches in HPLC and the latest developments in hyphenated techniques, the book captures the essence of major pharmaceutical applications (assays, stability testing, impurity testing, dissolution testing, cleaning validation, high-throughput screening). A complete reference guide to HPLC Describes best practices in HPLC and offers 'tricks of the trade' in HPLC operation and method development Reviews key HPLC pharmaceutical applications and highlights currents trends in HPLC ancillary techniques, sample preparations, and data handling
Handbook of Analytical Quality by Design
Author: Sarwar Beg
Publisher: Academic Press
ISBN: 0128203331
Category : Science
Languages : en
Pages : 225
Book Description
Handbook of Analytical Quality by Design addresses the steps involved in analytical method development and validation in an effort to avoid quality crises in later stages. The AQbD approach significantly enhances method performance and robustness which are crucial during inter-laboratory studies and also affect the analytical lifecycle of the developed method. Sections cover sample preparation problems and the usefulness of the QbD concept involving Quality Risk Management (QRM), Design of Experiments (DoE) and Multivariate (MVT) Statistical Approaches to solve by optimizing the developed method, along with validation for different techniques like HPLC, UPLC, UFLC, LC-MS and electrophoresis. This will be an ideal resource for graduate students and professionals working in the pharmaceutical industry, analytical chemistry, regulatory agencies, and those in related academic fields. - Concise language for easy understanding of the novel and holistic concept - Covers key aspects of analytical development and validation - Provides a robust, flexible, operable range for an analytical method with greater excellence and regulatory compliance
Publisher: Academic Press
ISBN: 0128203331
Category : Science
Languages : en
Pages : 225
Book Description
Handbook of Analytical Quality by Design addresses the steps involved in analytical method development and validation in an effort to avoid quality crises in later stages. The AQbD approach significantly enhances method performance and robustness which are crucial during inter-laboratory studies and also affect the analytical lifecycle of the developed method. Sections cover sample preparation problems and the usefulness of the QbD concept involving Quality Risk Management (QRM), Design of Experiments (DoE) and Multivariate (MVT) Statistical Approaches to solve by optimizing the developed method, along with validation for different techniques like HPLC, UPLC, UFLC, LC-MS and electrophoresis. This will be an ideal resource for graduate students and professionals working in the pharmaceutical industry, analytical chemistry, regulatory agencies, and those in related academic fields. - Concise language for easy understanding of the novel and holistic concept - Covers key aspects of analytical development and validation - Provides a robust, flexible, operable range for an analytical method with greater excellence and regulatory compliance
Pharmaceutical Manufacturing Handbook
Author: Shayne Cox Gad
Publisher: John Wiley & Sons
ISBN: 0470259825
Category : Science
Languages : en
Pages : 857
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.
Publisher: John Wiley & Sons
ISBN: 0470259825
Category : Science
Languages : en
Pages : 857
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.