Sarfaraz K. Niazi – författare

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73 produkter

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73 produkter

Filing Patents Online
A Professional Guide
AvSarfaraz K. Niazi
E-bok
PDF, Engelska, 2003
2 098 kr
Läs direkt efter köp
The average cost of an uncomplicated patent application filing is about $10,000. This high cost can leave thousands of inventors out in the cold. Filing Patents Online: A Professional Guide is a complete manual that walks inventors through each step of filing and prosecuting the patent online at a fraction of the cost. The online filing system reco
Future of Pharmaceuticals
A Nonlinear Analysis
AvSarfaraz K. Niazi
Häftad, Engelska, 2022
1 905 kr
Skickas inom 10-15 vardagar
Before now, biological systems could only be expressed in terms of linear relationships, however, as knowledge grows and new techniques of analysis on biological systems is made available, we are realizing the non-linearity of these systems. The concepts and techniques of nonlinear analysis allow for more realistic and accurate models in science. The Future of Pharmaceuticals: A Nonlinear Analysis provides an opportunity to understand the non-linearity of biological systems and its application in various areas of science, primarily pharmaceutical sciences. This book will benefit professionals in pharmaceutical industries, academia, and policy who are interested in an entirely new approach to how we will treat disease in the future.Key Features:Addresses a new approach of nonlinear analysis.Applies a theory of projection to chalk out the future, instead of basing on linear evolution. Provides an opportunity to better understand the non-linearity in biological systems and its applications in various areas of science, primarily pharmaceutical sciences.Helps change the thought process for those looking for answers to their questions which they do not find in the linear relationship approach.Encourages a broader perspective for the creative process of drug development.
Future of Pharmaceuticals
A Nonlinear Analysis
AvSarfaraz K. Niazi
Inbunden, Engelska, 2022
7 597 kr
Skickas inom 10-15 vardagar
Before now, biological systems could only be expressed in terms of linear relationships, however, as knowledge grows and new techniques of analysis on biological systems is made available, we are realizing the non-linearity of these systems. The concepts and techniques of nonlinear analysis allow for more realistic and accurate models in science. The Future of Pharmaceuticals: A Nonlinear Analysis provides an opportunity to understand the non-linearity of biological systems and its application in various areas of science, primarily pharmaceutical sciences. This book will benefit professionals in pharmaceutical industries, academia, and policy who are interested in an entirely new approach to how we will treat disease in the future.Key Features:Addresses a new approach of nonlinear analysis.Applies a theory of projection to chalk out the future, instead of basing on linear evolution. Provides an opportunity to better understand the non-linearity in biological systems and its applications in various areas of science, primarily pharmaceutical sciences.Helps change the thought process for those looking for answers to their questions which they do not find in the linear relationship approach.Encourages a broader perspective for the creative process of drug development.
Biopharmaceutical Manufacturing, Volume 1
Regulatory processes
AvSarfaraz K. Niazi,Sunitha Lokesh
Inbunden, Engelska, 2021
1 928 kr
Skickas inom 5-8 vardagar
Biopharmaceutical Manufacturing, Volume 1
Regulatory processes
AvSarfaraz K Niazi,Sunitha Lokesh
Häftad, Engelska, 2021
409 kr
Skickas inom 5-8 vardagar
Biopharmaceutical Manufacturing, Volume 2
Unit processes
AvSarfaraz K. Niazi,Sunitha Lokesh
Inbunden, Engelska, 2022
1 908 kr
Skickas inom 5-8 vardagar
Biopharmaceutical Manufacturing, Volume 2
Unit processes
AvSarfaraz K Niazi,Sunitha Lokesh
Häftad, Engelska, 2022
413 kr
Skickas inom 5-8 vardagar
Future of Pharmaceuticals
A Nonlinear Analysis
AvSarfaraz K. Niazi
E-bok
PDF, Engelska, 2022
1 815 kr
Läs direkt efter köp
Before now, biological systems could only be expressed in terms of linear relationships, however, as knowledge grows and new techniques of analysis on biological systems is made available, we are realizing the non-linearity of these systems. The concepts and techniques of nonlinear analysis allow for more realistic and accurate models in science. The Future of Pharmaceuticals: A Nonlinear Analysis provides an opportunity to understand the non-linearity of biological systems and its application in various areas of science, primarily pharmaceutical sciences. This book will benefit professionals in pharmaceutical industries, academia, and policy who are interested in an entirely new approach to how we will treat disease in the future.
Key Features:
Addresses a new approach of nonlinear analysis. Applies a theory of projection to chalk out the future, instead of basing on linear evolution. Provides an opportunity to better understand the non-linearity in biological systems and its applications in various areas of science, primarily pharmaceutical sciences. Helps change the thought process for those looking for answers to their questions which they do not find in the linear relationship approach. Encourages a broader perspective for the creative process of drug development.
Future of Pharmaceuticals
A Nonlinear Analysis
AvSarfaraz K. Niazi
E-bok
Engelska, 2022
1 815 kr
Läs direkt efter köp
Before now, biological systems could only be expressed in terms of linear relationships, however, as knowledge grows and new techniques of analysis on biological systems is made available, we are realizing the non-linearity of these systems. The concepts and techniques of nonlinear analysis allow for more realistic and accurate models in science. The Future of Pharmaceuticals: A Nonlinear Analysis provides an opportunity to understand the non-linearity of biological systems and its application in various areas of science, primarily pharmaceutical sciences. This book will benefit professionals in pharmaceutical industries, academia, and policy who are interested in an entirely new approach to how we will treat disease in the future.
Key Features:
Addresses a new approach of nonlinear analysis. Applies a theory of projection to chalk out the future, instead of basing on linear evolution. Provides an opportunity to better understand the non-linearity in biological systems and its applications in various areas of science, primarily pharmaceutical sciences. Helps change the thought process for those looking for answers to their questions which they do not find in the linear relationship approach. Encourages a broader perspective for the creative process of drug development.
mRNA Therapeutics
Fast-to-Market Strategies
AvSarfaraz K. Niazi
E-bok
PDF, Engelska, 2022
881 kr
Läs direkt efter köp
This book is the most comprehensive and complete treatise on nucleic acid therapeuticproducts, including mRNA vaccines, their manufacturing, formulations, andtesting for safety and efficacy. Details include cGMP-compliant manufacturing andregulatory filing steps. A new concept of “biosimilar” mRNA vaccine is presentedto secure fast approval of copies of mRNA vaccines. Projections of financial plansto establish RNA manufacturing facilities are provided, along with details of supplychain management. Finally, the future of nucleic acid products in gene therapy andother newer applications is presented, along with a perspective that all new vaccineswill be the nucleic acid type that will further provide first-time prevention of autoimmunedisorders. It is projected that both big pharma and start-ups will enter this field,and we can expect significant additions to our drug armamentarium soon.
mRNA Therapeutics
Fast-to-Market Strategies
AvSarfaraz K. Niazi
E-bok
Engelska, 2022
872 kr
Läs direkt efter köp
This book is the most comprehensive and complete treatise on nucleic acid therapeuticproducts, including mRNA vaccines, their manufacturing, formulations, andtesting for safety and efficacy. Details include cGMP-compliant manufacturing andregulatory filing steps. A new concept of “biosimilar” mRNA vaccine is presentedto secure fast approval of copies of mRNA vaccines. Projections of financial plansto establish RNA manufacturing facilities are provided, along with details of supplychain management. Finally, the future of nucleic acid products in gene therapy andother newer applications is presented, along with a perspective that all new vaccineswill be the nucleic acid type that will further provide first-time prevention of autoimmunedisorders. It is projected that both big pharma and start-ups will enter this field,and we can expect significant additions to our drug armamentarium soon.
mRNA Therapeutics
Fast-to-Market Strategies
AvSarfaraz K. Niazi
Inbunden, Engelska, 2022
2 445 kr
Skickas inom 10-15 vardagar
This book is the most comprehensive and complete treatise on nucleic acid therapeuticproducts, including mRNA vaccines, their manufacturing, formulations, andtesting for safety and efficacy. Details include cGMP-compliant manufacturing andregulatory filing steps. A new concept of “biosimilar” mRNA vaccine is presentedto secure fast approval of copies of mRNA vaccines. Projections of financial plansto establish RNA manufacturing facilities are provided, along with details of supplychain management. Finally, the future of nucleic acid products in gene therapy andother newer applications is presented, along with a perspective that all new vaccineswill be the nucleic acid type that will further provide first-time prevention of autoimmunedisorders. It is projected that both big pharma and start-ups will enter this field,and we can expect significant additions to our drug armamentarium soon.
mRNA Therapeutics
Fast-to-Market Strategies
AvSarfaraz K. Niazi
Häftad, Engelska, 2024
679 kr
This book is the most comprehensive and complete treatise on nucleic acid therapeuticproducts, including mRNA vaccines, their manufacturing, formulations, andtesting for safety and efficacy. Details include cGMP-compliant manufacturing andregulatory filing steps. A new concept of “biosimilar” mRNA vaccine is presentedto secure fast approval of copies of mRNA vaccines. Projections of financial plansto establish RNA manufacturing facilities are provided, along with details of supplychain management. Finally, the future of nucleic acid products in gene therapy andother newer applications is presented, along with a perspective that all new vaccineswill be the nucleic acid type that will further provide first-time prevention of autoimmunedisorders. It is projected that both big pharma and start-ups will enter this field,and we can expect significant additions to our drug armamentarium soon.
Handbook of Preformulation
Chemical, Biological, and Botanical Drugs, Second Edition
AvSarfaraz K. Niazi
Häftad, Engelska, 2022
795 kr
Skickas inom 10-15 vardagar
Preformulation studies are the physical, chemical, and biological studies needed to characterize a drug substance for enabling the proper design of a drug product, whereas the effectiveness of a drug product is determined during the formulation studies phase. Though the two disciplines overlap in practice, each is a significantly distinct phase of new drug development. Entirely focused on preformulation principles, this fully revised and updated Handbook of Preformulation: Chemical, Biological, and Botanical Drugs, Second Edition provides detailed descriptions of preformulation methodologies, gives a state-of-the-art description of each technique, and lists the currently available tools useful in providing a comprehensive characterization of a new drug entity.Features:Addresses the preformulation studies of three different types of new active entities - chemical, biological, and botanical, which is the latest established class of active ingredient classified by the FDAIllustrates the activities comprised in preformulation studies and establishes a method of tasking for drug development projectsIncludes extensive flow charts for characterization decision makingGives extensive theoretical treatment of principles important for testing dissolution, solubility, stability, and solid state characterizationIncludes over 50% new material
Biosimilars Development Strategies
Fast to Market Approaches
AvSarfaraz K. Niazi
Inbunden, Engelska, 2024
2 076 kr
Skickas inom 10-15 vardagar
After 18 years since the first biosimilar was approved, a lot has changed, from the regulatory guidelines to the stakeholder perceptions about the safety and efficacy of biosimilars. However, the development costs remain high, preventing faster entry into markets with more than 200 choices. Analyzing the regulatory filings of all approved biosimilars in the US and EU, a deep analysis of the scientific principles, and continuous challenges to the regulatory authorities have made it possible to plan the development on a fast track. This book teaches how to cut the current time and cost by more than 70%, based on the author's hands-on experience.Features:Describes the emergence of biosimilars since the first publication of the recombinant engineering patent, as well as a listing of all approved recombinant products, their patent expiry and their adoption across the globe. Provides a better understanding of the safety and efficacy of approved biosimilars. Global approval requires accommodating guidelines and detailed planning to avoid redundancy as well as high costs. The basic expectations of the agencies are presented here. Presents a detailed analysis of all EU and FDA-approved products with a comparative analysis. Renowned author and entrepreneur in the field of drug discovery and production.
Biosimilars Development Strategies
Fast to Market Approaches
AvSarfaraz K. Niazi
Häftad, Engelska, 2025
737 kr
Skickas inom 10-15 vardagar
After 18 years since the first biosimilar was approved, a lot has changed, from the regulatory guidelines to the stakeholder perceptions about the safety and efficacy of biosimilars. However, the development costs remain high, preventing faster entry into markets with more than 200 choices. Analyzing the regulatory filings of all approved biosimilars in the US and EU, a deep analysis of the scientific principles, and continuous challenges to the regulatory authorities have made it possible to plan the development on a fast track. This book teaches how to cut the current time and cost by more than 70%, based on the author's hands-on experience.Features:Describes the emergence of biosimilars since the first publication of the recombinant engineering patent, as well as a listing of all approved recombinant products, their patent expiry and their adoption across the globe. Provides a better understanding of the safety and efficacy of approved biosimilars. Global approval requires accommodating guidelines and detailed planning to avoid redundancy as well as high costs. The basic expectations of the agencies are presented here. Presents a detailed analysis of all EU and FDA-approved products with a comparative analysis. Renowned author and entrepreneur in the field of drug discovery and production.
Biosimilars and Interchangeable Biologics
Tactical Elements
AvSarfaraz K. Niazi
Häftad, Engelska, 2023
824 kr
Skickas inom 10-15 vardagar
What’s the Deal with Biosimilars?Biosimilars are gaining momentum as new protein therapeutic candidates that can help fill a vital need in the healthcare industry. The biological drugs are produced by recombinant DNA technology that allows for large-scale production and an overall reduction time in costs and development. Part of a two-volume set that covers varying aspects of biosimilars, Biosimilars and Interchangeable Biologics: Tactical Elements explores the development and manufacturing of biosimilars and targets challenges surrounding the creation of these products. This includes manufacturing, production costs, and intellectual property barriers, particularly in regulated markets (regulatory agencies are still in the process of developing guidelines). It addresses the complexity of biological drugs, and it discusses specific structural elements vital to the functionality, immunogenicity, and safety of biosimilar products.Of specific interest to practitioners, researchers, and scientists in the biopharmaceutical industry, this volume provides an overall understanding of the hurdles, difficulties, and practicalities of developing a strong plan. It introduces a step-by-step approach for creating a strategy that helps develop and manufacture a biosimilar product while reducing overall production costs and meeting the requirements of biosimilarity based on analytical and functional, pharmacokinetic, pharmacodynamic (where applicable), and nonclinical toxicology or toxicokinetic similarity (where appropriate) while remaining competitive in the market.
Biosimilarity
The FDA Perspective
AvSarfaraz K. Niazi
Häftad, Engelska, 2023
801 kr
Skickas inom 10-15 vardagar
Summary:The focus of this book is on how the U.S. FDA will approve biosimilar drugs, as learned from recent approvals by the FDA. Understanding the limitations of the statutory limits and non-inferiority testing are presented as tools to obviate patient trials and minimize testing of immunogenicity. An in-depth scientific, mathematical and statistical view of the tools required to establish biosimilarity of biological drugs of different complexity -- a must for every developer of biosimilars.Features: First comprehensive analysis based on new guidelines and approval packages of several biosimilarsPresents the first approach to challenge FDA in reducing or eliminating any testing in patients.Provides a comprehensive understanding of the U.S. statutory requirements vis-a-vis the regulatory guidelinesProvides model CQA and Analytical Similarity testing protocols for cytokines and monoclonal antibodiesAllow creation of a fast-to-market pathway to develop biosimilars
Biosimilars and Interchangeable Biologics
Strategic Elements
AvSarfaraz K. Niazi
Inbunden, Engelska, 2025
3 437 kr
Skickas inom 10-15 vardagar
This new edition explores the strategic planning side of biosimilar drugs and targets the issues surrounding biosimilars that are linked to legal matters. This includes an examination of new regulatory requirements in terms of principal patents and intellectual property, regulatory pathways, and concerns about affordability on a global scale.Biosimilars and Interchangeable Biologics: Strategic Elements, Second edition, examines the science, technology, finance, legality, ethics, and politics of biosimilar drugs. The book presents a global strategy on how to build, take to market, and manage the next generation of biosimilars throughout their life cycle. Updated throughout, the book covers strategic planning elements that include an overall understanding of the history and the current status of the science and art of biosimilars. As the perception of biosimilars has changed over the last several years, the author provides detailed descriptions of the new legal, regulatory, and commercial characteristics that must be considered. He also addresses the utilization of biosimilars and related biological drugs in expanding world markets, and reviews new strategies and tactics to enable users to create a universal dossier. Finally, there is also an examination of newer technologies that will help reduce the capital costs of manufacturing and bringing biosimilars to market.The book is intended for pharmaceutical scientists, engineers in biotechnology, regulatory specialists, analytical chemists, and quality assurance specialists in biopharmaceuticals.
Handbook of Pharmaceutical Manufacturing Formulations, Third Edition
Taylor & Francis Ltd
2024
9 475 kr
Skickas inom 10-15 vardagar
The Handbook of Pharmaceutical Manufacturing Formulations, Third Edition is an authoritative and practical guide to the art and science of formulating drugs for commercial manufacturing. With thoroughly revised and expanded content, this six-volume set compiles data from FDA new drug applications, patent applications, and other sources of generic and proprietary formulations to cover the broad spectrum of GMP 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.
Handbook of Bioequivalence Testing
AvSarfaraz K. Niazi
Häftad, Engelska, 2024
671 kr
Skickas inom 10-15 vardagar
As the generic pharmaceutical industry continues to grow and thrive, so does the need to conduct adequate, efficient bioequivalence studies. In recent years, there have been significant changes to the statistical models for evaluating bioequivalence. In addition, advances in the analytical technology used to detect drug and metabolite levels have made bioequivalence testing more complex. The second edition of Handbook of Bioequivalence Testing has been completely updated to include the most current information available, including new findings in drug delivery and dosage form design and revised worldwide regulatory requirements.New topics include:A historical perspective on generic pharmaceuticalsNew guidelines governing submissions related to bioequivalency studies, along with therapeutic code classificationsModels of noninferiority Biosimilarity of large molecule drugsBioequivalence of complementary and alternate medicinesBioequivalence of biosimilar therapeutic proteins and monoclonal antibodiesNew FDA guidelines for bioanalytical method validationOutsourcing and monitoring of bioequivalence studiesThe cost of generic drugs is rising much faster than in the past, partly because of the increased costs required for approval—including those for bioequivalence testing. There is a dire need to re-examine the science behind this type of testing to reduce the burden of development costs—allowing companies to develop generic drugs faster and at a lower expense. The final chapter explores the future of bioequivalence testing and proposes radical changes in the process of biowaivers. It suggests how the cost of demonstrating bioequivalence can be reduced through intensive analytical investigation and proposes that regulatory agencies reduce the need for bioequivalence studies in humans. Backed by science and updated with the latest research, this book is destined to spark continued debate on the efficacy of the current bioequivalence testing paradigm.
Handbook of Pharmaceutical Manufacturing Formulations, Third Edition
Volume One, Compressed Solid Products
AvSarfaraz K. Niazi
Häftad, Engelska, 2024
752 kr
Skickas inom 10-15 vardagar
The Handbook of Pharmaceutical Manufacturing Formulations, Third Edition: Volume One, Compressed Solid 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 first volume of a six-volume set, compiles data from FDA new drug applications, patent applications, and other sources of generic and proprietary formulations to cover the broad spectrum of GMP 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.
Handbook of Pharmaceutical Manufacturing Formulations, Third Edition
Volume Four, Semisolid Products
AvSarfaraz K. Niazi
Häftad, Engelska, 2024
752 kr
Skickas inom 10-15 vardagar
The Handbook of Pharmaceutical Manufacturing Formulations, Third Edition: Volume Four, Semisolid 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 fourth 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
Handbook of Pharmaceutical Manufacturing Formulations, Third Edition
Volume Five, Over-the-Counter Products
AvSarfaraz K. Niazi
Häftad, Engelska, 2024
752 kr
Skickas inom 10-15 vardagar
The Handbook of Pharmaceutical Manufacturing Formulations, Third Edition: Volume Five, Over-the-Counter 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 fifth 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
Handbook of Pharmaceutical Manufacturing Formulations, Third Edition
Volume Six, Sterile Products
AvSarfaraz K. Niazi
Häftad, Engelska, 2024
752 kr
Skickas inom 10-15 vardagar
The Handbook of Pharmaceutical Manufacturing Formulations, Third Edition: Volume Six, Sterile 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 sixth 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
Handbook of Pharmaceutical Manufacturing Formulations, Third Edition
Volume Two, Uncompressed Solid Products
AvSarfaraz K. Niazi
Häftad, Engelska, 2024
752 kr
Skickas inom 10-15 vardagar
The Handbook of Pharmaceutical Manufacturing Formulations, Third Edition: Volume Two, Uncompressed Solid 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 second 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
Handbook of Pharmaceutical Manufacturing Formulations, Third Edition
Volume Three, Liquid Products
AvSarfaraz K. Niazi
Häftad, Engelska, 2024
752 kr
Skickas inom 10-15 vardagar
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
Biosimilars and Interchangeable Biologics
Tactical Elements
AvSarfaraz K. Niazi
E-bok
Engelska, 2016
939 kr
Läs direkt efter köp
What's the Deal with Biosimilars?Biosimilars are gaining momentum as new protein therapeutic candidates that can help fill a vital need in the healthcare industry. The biological drugs are produced by recombinant DNA technology that allows for large-scale production and an overall reduction time in costs and development. Part of a two-volume set that covers varying aspects of biosimilars, Biosimilars and Interchangeable Biologics: Tactical Elements explores the development and manufacturing of biosimilars and targets challenges surrounding the creation of these products. This includes manufacturing, production costs, and intellectual property barriers, particularly in regulated markets (regulatory agencies are still in the process of developing guidelines). It addresses the complexity of biological drugs, and it discusses specific structural elements vital to the functionality, immunogenicity, and safety of biosimilar products.Of specific interest to practitioners, researchers, and scientists in the biopharmaceutical industry, this volume provides an overall understanding of the hurdles, difficulties, and practicalities of developing a strong plan. It introduces a step-by-step approach for creating a strategy that helps develop and manufacture a biosimilar product while reducing overall production costs and meeting the requirements of biosimilarity based on analytical and functional, pharmacokinetic, pharmacodynamic (where applicable), and nonclinical toxicology or toxicokinetic similarity (where appropriate) while remaining competitive in the market.
Biosimilars Development Strategies
Fast to Market Approaches
AvSarfaraz K. Niazi
E-bok
PDF, Engelska, 2024
864 kr
Läs direkt efter köp
After 18 years since the first biosimilar was approved, a lot has changed, from the regulatory guidelines to the stakeholder perceptions about the safety and efficacy of biosimilars. However, the development costs remain high, preventing faster entry into markets with more than 200 choices. Analyzing the regulatory filings of all approved biosimilars in the US and EU, a deep analysis of the scientific principles, and continuous challenges to the regulatory authorities have made it possible to plan the development on a fast track. This book teaches how to cut the current time and cost by more than 70%, based on the author''s hands-on experience.
Features:
Describes the emergence of biosimilars since the first publication of the recombinant engineering patent, as well as a listing of all approved recombinant products, their patent expiry and their adoption across the globe. Provides a better understanding of the safety and efficacy of approved biosimilars. Global approval requires accommodating guidelines and detailed planning to avoid redundancy as well as high costs. The basic expectations of the agencies are presented here. Presents a detailed analysis of all EU and FDA-approved products with a comparative analysis. Renowned author and entrepreneur in the field of drug discovery and production.
Biosimilars Development Strategies
Fast to Market Approaches
AvSarfaraz K. Niazi
E-bok
Engelska, 2024
864 kr
Läs direkt efter köp
After 18 years since the first biosimilar was approved, a lot has changed, from the regulatory guidelines to the stakeholder perceptions about the safety and efficacy of biosimilars. However, the development costs remain high, preventing faster entry into markets with more than 200 choices. Analyzing the regulatory filings of all approved biosimilars in the US and EU, a deep analysis of the scientific principles, and continuous challenges to the regulatory authorities have made it possible to plan the development on a fast track. This book teaches how to cut the current time and cost by more than 70%, based on the author''s hands-on experience.
Features:
Describes the emergence of biosimilars since the first publication of the recombinant engineering patent, as well as a listing of all approved recombinant products, their patent expiry and their adoption across the globe. Provides a better understanding of the safety and efficacy of approved biosimilars. Global approval requires accommodating guidelines and detailed planning to avoid redundancy as well as high costs. The basic expectations of the agencies are presented here. Presents a detailed analysis of all EU and FDA-approved products with a comparative analysis. Renowned author and entrepreneur in the field of drug discovery and production.

Sarfaraz K. Niazi – författare

Filing Patents Online

Future of Pharmaceuticals

Future of Pharmaceuticals

Biopharmaceutical Manufacturing, Volume 1

Biopharmaceutical Manufacturing, Volume 1

Biopharmaceutical Manufacturing, Volume 2

Biopharmaceutical Manufacturing, Volume 2

Future of Pharmaceuticals

Future of Pharmaceuticals

mRNA Therapeutics

mRNA Therapeutics

mRNA Therapeutics

mRNA Therapeutics

Handbook of Preformulation

Biosimilars Development Strategies

Biosimilars Development Strategies

Biosimilars and Interchangeable Biologics

Biosimilarity

Biosimilars and Interchangeable Biologics

Handbook of Pharmaceutical Manufacturing Formulations, Third Edition

Handbook of Bioequivalence Testing

Handbook of Pharmaceutical Manufacturing Formulations, Third Edition

Handbook of Pharmaceutical Manufacturing Formulations, Third Edition

Handbook of Pharmaceutical Manufacturing Formulations, Third Edition

Handbook of Pharmaceutical Manufacturing Formulations, Third Edition

Handbook of Pharmaceutical Manufacturing Formulations, Third Edition

Handbook of Pharmaceutical Manufacturing Formulations, Third Edition

Biosimilars and Interchangeable Biologics

Biosimilars Development Strategies

Biosimilars Development Strategies