SARFARAZ K. NIAZI's Books

Handbook of Pharmaceutical Manufacturing Formulations Third Edition

By: Sarfaraz K. Niazi

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Handbook of Pharmaceutical Manufacturing Formulations Third Edition

By: Sarfaraz K. Niazi

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.

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554

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ISBN 10

1138102806

ISBN 13

9781138102804

Biosimilarity

The FDA Perspective

By: Sarfaraz K. Niazi

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Biosimilarity

The FDA Perspective

By: Sarfaraz K. Niazi

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 biosimilars Presents 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 guidelines Provides model CQA and Analytical Similarity testing protocols for cytokines and monoclonal antibodies Allow creation of a fast-to-market pathway to develop biosimilars

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436

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CRC Press

Published Date

ISBN 10

1498750400

ISBN 13

9781498750400

Disposable Bioprocessing Systems

By: Sarfaraz K. Niazi

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Disposable Bioprocessing Systems

By: Sarfaraz K. Niazi

Written by a researcher with experience designing, establishing, and validating biological manufacturing facilities worldwide, this is the first comprehensive introduction to disposable systems for biological drug manufacturing. It reviews the current state of the industry; tackles questions about safety, costs, regulations, and waste disposal; and guides readers to choose disposable components that meet their needs. This practical manual covers disposable containers, mixing systems, bioreactors, connectors and transfers, controls and sensors, downstream processing systems, filling and finishing systems, and filters. The author also shares his predictions for the future, calling disposable bioprocessing technology a "game changer.

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325

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CRC Press

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ISBN 10

1000218740

ISBN 13

9781000218749

Handbook of Pharmaceutical Manufacturing Formulations, Third Edition

Volume One, Compressed Solid Products

By: Sarfaraz K. Niazi

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Handbook of Pharmaceutical Manufacturing Formulations, Third Edition

Volume One, Compressed Solid Products

By: Sarfaraz K. Niazi

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593

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CRC Press

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ISBN 10

1351594915

ISBN 13

9781351594912

Handbook of Pharmaceutical Manufacturing Formulations

Volume One, Compressed Solid Products

By: Sarfaraz K. Niazi

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Handbook of Pharmaceutical Manufacturing Formulations

Volume One, Compressed Solid Products

By: Sarfaraz K. Niazi

The largest category of pharmaceutical formulations, comprising almost two-thirds of all dosage forms, compressed solids present some of the greatest challenges to formulation scientists. The first volume, Compressed Solid Products, tackles these challenges head on.Highlights from Compressed Solid Products, Volume One include:formulations for

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646

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CRC Press

Published Date

ISBN 10

1420081179

ISBN 13

9781420081176

Handbook of Preformulation

Chemical, Biological, and Botanical Drugs, Second Edition

By: Sarfaraz K. Niazi

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Handbook of Preformulation

Chemical, Biological, and Botanical Drugs, Second Edition

By: Sarfaraz K. Niazi

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 FDA Illustrates the activities comprised in preformulation studies and establishes a method of tasking for drug development projects Includes extensive flow charts for characterization decision making Gives extensive theoretical treatment of principles important for testing dissolution, solubility, stability, and solid state characterization Includes over 50% new material

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544

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CRC Press

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ISBN 10

1351582348

ISBN 13

9781351582346

Biosimilars and Interchangeable Biologics

Strategic Elements

By: Sarfaraz K. Niazi

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Biosimilars and Interchangeable Biologics

Strategic Elements

By: Sarfaraz K. Niazi

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: Strategic Elements explores the strategic planning side of biosimilar drugs and targets issues surrounding biosimilars that are linked to legal matters. This includes principal patents and intellectual property, regulatory pathways, and concerns about affordability on a global scale. It addresses the complexity of biosimilar products, and it discusses the utilization of biosimilars and related biological drugs in expanding world markets. Of specific interest to practitioners, researchers, and scientists in the biopharmaceutical industry, this volume examines the science, technology, finance, legality, ethics, and politics of biosimilar drugs. It considers strategic planning elements that include an overall understanding of the history and the current status of the art and science of biosimilars, and it provides detailed descriptions of the legal, regulatory, and commercial characteristics. The book also presents a global strategy on how to build, take to market, and manage the next generation of biosimilars throughout their life cycle.

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638

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CRC Press

Published Date

ISBN 10

1351231308

ISBN 13

9781351231305

The Future of Pharmaceuticals

A Nonlinear Analysis

By: Sarfaraz K. Niazi

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The Future of Pharmaceuticals

A Nonlinear Analysis

By: Sarfaraz K. Niazi

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.

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620

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CRC Press

Published Date

ISBN 10

1000458164

ISBN 13

9781000458169

Handbook of Bioequivalence Testing, Second Edition

By: Sarfaraz K. Niazi

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Handbook of Bioequivalence Testing, Second Edition

By: Sarfaraz K. Niazi

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 pharmaceuticals New guidelines governing submissions related to bioequivalency studies, along with therapeutic code classifications Models of noninferiority Biosimilarity of large molecule drugs Bioequivalence of complementary and alternate medicines Bioequivalence of biosimilar therapeutic proteins and monoclonal antibodies New FDA guidelines for bioanalytical method validation Outsourcing and monitoring of bioequivalence studies The 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.

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1012

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CRC Press

Published Date

ISBN 10

1482226375

ISBN 13

9781482226379

Fundamentals of Modern Bioprocessing

By: Sarfaraz K. Niazi,Justin L. Brown

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Fundamentals of Modern Bioprocessing

By: Sarfaraz K. Niazi,Justin L. Brown

Biological drug and vaccine manufacturing has quickly become one of the highest-value fields of bioprocess engineering, and many bioprocess engineers are now finding job opportunities that have traditionally gone to chemical engineers. Fundamentals of Modern Bioprocessing addresses this growing demand. Written by experts well-established in the field, this book connects the principles and applications of bioprocessing engineering to healthcare product manufacturing and expands on areas of opportunity for qualified bioprocess engineers and students. The book is divided into two sections: the first half centers on the engineering fundamentals of bioprocessing; while the second half serves as a handbook offering advice and practical applications. Focused on the fundamental principles at the core of this discipline, this work outlines every facet of design, component selection, and regulatory concerns. It discusses the purpose of bioprocessing (to produce products suitable for human use), describes the manufacturing technologies related to bioprocessing, and explores the rapid expansion of bioprocess engineering applications relevant to health care product manufacturing. It also considers the future of bioprocessing—the use of disposable components (which is the fastest growing area in the field of bioprocessing) to replace traditional stainless steel. In addition, this text: Discusses the many types of genetically modified organisms Outlines laboratory techniques Includes the most recent developments Serves as a reference and contains an extensive bibliography Emphasizes biological manufacturing using recombinant processing, which begins with creating a genetically modified organism using recombinant techniques Fundamentals of Modern Bioprocessing outlines both the principles and applications of bioprocessing engineering related to healthcare product manufacturing. It lays out the basic concepts, definitions, methods and applications of bioprocessing. A single volume comprehensive reference developed to meet the needs of students with a bioprocessing background; it can also be used as a source for professionals in the field.

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746

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CRC Press

Published Date

ISBN 10

1466585749

ISBN 13

9781466585744

mRNA Therapeutics

Fast-to-Market Strategies

By: Sarfaraz K. Niazi

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mRNA Therapeutics

Fast-to-Market Strategies

By: Sarfaraz K. Niazi

This book is the most comprehensive and complete treatise on nucleic acid therapeutic products, including mRNA vaccines, their manufacturing, formulations, and testing for safety and efficacy. Details include cGMP-compliant manufacturing and regulatory filing steps. A new concept of “biosimilar” mRNA vaccine is presented to secure fast approval of copies of mRNA vaccines. Projections of financial plans to establish RNA manufacturing facilities are provided, along with details of supply chain management. Finally, the future of nucleic acid products in gene therapy and other newer applications is presented, along with a perspective that all new vaccines will be the nucleic acid type that will further provide first-time prevention of autoimmune disorders. 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.

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327

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CRC Press

Published Date

ISBN 10

1000788067

ISBN 13

9781000788068

Handbook of Bioequivalence Testing

By: Sarfaraz K. Niazi

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Handbook of Bioequivalence Testing

By: Sarfaraz K. Niazi

As the generic pharmaceutical industry continues to grow and thrive, so does the need to conduct efficient and successful bioequivalence studies. In recent years, there have been significant changes to the statistical models for evaluating bioequivalence, and advances in the analytical technology used to detect drug and metabolite levels have made

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602

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CRC Press

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ISBN 10

0849383595

ISBN 13

9780849383595

Biosimilars Development Strategies

Fast to Market Approaches

By: Sarfaraz K. Niazi

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Biosimilars Development Strategies

Fast to Market Approaches

By: Sarfaraz K. Niazi

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.

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204

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CRC Press

Published Date

ISBN 10

1040090486

ISBN 13

9781040090480

Handbook of Biogeneric Therapeutic Proteins

Regulatory, Manufacturing, Testing, and Patent Issues

By: Sarfaraz K. Niazi

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Handbook of Biogeneric Therapeutic Proteins

Regulatory, Manufacturing, Testing, and Patent Issues

By: Sarfaraz K. Niazi

More than 20 billion dollars worth of biopharmaceuticals are scheduled to go off-patent by 2006. Given the strong political impetus and the development of technological tools that can answer the questions regulatory authorities may raise, it is inevitable that the FDA and EMEA will allow biogeneric or biosimilar products. Even with all the regulato

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592

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CRC Press

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ISBN 10

1000611329

ISBN 13

9781000611328

Handbook of Biological Therapeutic Proteins

Regulatory, Manufacturing, Testing, and Patent Issues

By: Sarfaraz Niazi

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Handbook of Biological Therapeutic Proteins

Regulatory, Manufacturing, Testing, and Patent Issues

By: Sarfaraz Niazi

Since 1972, which marks the invention of recombinant engineering, more than 500 therapeutic proteins have been approved for clinical use. Today, biological drugs constitute almost 70% of all new drugs and have a biological origin. The first edition of this book dealt with biosimilars, and this edition (i.e., the second edition) focuses on new drugs, yet limits to therapeutic proteins. Newer technologies for drug development represent the updated topics in the book and include repur-posing, AI- driven identification of newer designs, novel expression systems, manufacturing using these systems, rapidly changing regulatory pathways, and legal hurdles. This edition discusses how to identify, develop, manufacture, and take multibillion dollar products to market within the shortest possible time. Features: Complete and thorough coverage of the regulatory and technological challenges of developing generic therapeutic proteins Comprehensive, discovery to market, newer technologies, regulatory planning and IP hurdles are included that are not found elsewhere Expanded volume that must be in the hands of every company interested in biological drugs, including the mRNA-based biopharmaceutical companies fast appearing on the market Discusses how to identify, develop, manufacture, and take multibillion dollar products to market in the shortest possible time Renowned author and entrepreneur in the field of drug discovery and production

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413

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CRC Press

Published Date

ISBN 10

1003860206

ISBN 13

9781003860204

Biosimilars and Interchangeable Biologics

Tactical Elements

By: Sarfaraz K. Niazi

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Biosimilars and Interchangeable Biologics

Tactical Elements

By: Sarfaraz K. Niazi

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 th

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612

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CRC Press

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ISBN 10

1498743501

ISBN 13

9781498743501

Biosimilarity

The FDA Perspective

By: Sarfaraz K. Niazi

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Biosimilarity

The FDA Perspective

By: Sarfaraz K. Niazi

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455

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CRC Press

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ISBN 10

1315351374

ISBN 13

9781315351377

Filing Patents Online

A Professional Guide

By: Sarfaraz K. Niazi

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Filing Patents Online

A Professional Guide

By: Sarfaraz K. Niazi

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

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464

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CRC Press

Published Date

ISBN 10

0203485122

ISBN 13

9780203485125

Handbook of Pharmaceutical Manufacturing Formulations, Third Edition

Volume One, Compressed Solid Products

By: Sarfaraz K. Niazi

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Handbook of Pharmaceutical Manufacturing Formulations, Third Edition

Volume One, Compressed Solid Products

By: Sarfaraz K. Niazi

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816

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CRC Press

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ISBN 10

1351594907

ISBN 13

9781351594905

Handbook of Bioequivalence Testing

By: Sarfaraz K. Niazi

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Handbook of Bioequivalence Testing

By: Sarfaraz K. Niazi

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992

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CRC Press

Published Date

ISBN 10

1482226383

ISBN 13

9781482226386

Filing Patents Online

A Professional Guide

By: Sarfaraz K. Niazi

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Filing Patents Online

A Professional Guide

By: Sarfaraz K. Niazi

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464

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ISBN 10

0203485122

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9780203485125

Disposable Bioprocessing Systems

By: Sarfaraz K. Niazi

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Disposable Bioprocessing Systems

By: Sarfaraz K. Niazi

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323

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CRC Press

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ISBN 10

1439866953

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9781439866955

Biosimilars and Interchangeable Biologics

Strategic Elements

By: Sarfaraz K. Niazi

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Biosimilars and Interchangeable Biologics

Strategic Elements

By: Sarfaraz K. Niazi

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638

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1351231308

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9781351231305

mRNA Therapeutics

Fast-to-Market Strategies

By: Sarfaraz K. Niazi

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mRNA Therapeutics

Fast-to-Market Strategies

By: Sarfaraz K. Niazi

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327

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ISBN 10

1000788067

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9781000788068

Handbook of Pharmaceutical Manufacturing Formulations, Third Edition

Volume Six, Sterile Products

By: Sarfaraz K. Niazi

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Handbook of Pharmaceutical Manufacturing Formulations, Third Edition

Volume Six, Sterile Products

By: Sarfaraz K. Niazi

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

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540

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CRC Press

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ISBN 10

135159222X

ISBN 13

9781351592222

Handbook of Biogeneric Therapeutic Proteins

Regulatory, Manufacturing, Testing, and Patent Issues

By: Sarfaraz K. Niazi

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Handbook of Biogeneric Therapeutic Proteins

Regulatory, Manufacturing, Testing, and Patent Issues

By: Sarfaraz K. Niazi

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592

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ISBN 10

1000611329

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9781000611328

Handbook of Pharmaceutical Manufacturing Formulations, Third Edition

Volume Three, Liquid Products

By: Sarfaraz K. Niazi

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Handbook of Pharmaceutical Manufacturing Formulations, Third Edition

Volume Three, Liquid Products

By: Sarfaraz K. Niazi

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

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580

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CRC Press

Published Date

ISBN 10

1351593501

ISBN 13

9781351593502

Handbook of Pharmaceutical Manufacturing Formulations, Third Edition

Volume Five, Over-the-Counter Products

By: Sarfaraz K. Niazi

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Handbook of Pharmaceutical Manufacturing Formulations, Third Edition

Volume Five, Over-the-Counter Products

By: Sarfaraz K. Niazi

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

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453

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CRC Press

Published Date

ISBN 10

1351592351

ISBN 13

9781351592352

Handbook of Pharmaceutical Manufacturing Formulations, Third Edition

Volume Four, Semisolid Products

By: Sarfaraz K. Niazi

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Handbook of Pharmaceutical Manufacturing Formulations, Third Edition

Volume Four, Semisolid Products

By: Sarfaraz K. Niazi

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

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614

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CRC Press

Published Date

ISBN 10

1351593323

ISBN 13

9781351593328

Handbook of Pharmaceutical Manufacturing Formulations, Third Edition

Volume Two, Uncompressed Solid Products

By: Sarfaraz K. Niazi

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Handbook of Pharmaceutical Manufacturing Formulations, Third Edition

Volume Two, Uncompressed Solid Products

By: Sarfaraz K. Niazi

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

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Page Count

602

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CRC Press

Published Date

ISBN 10

1351593595

ISBN 13

9781351593595

Handbook of Biological Therapeutic Proteins

Regulatory, Manufacturing, Testing, and Patent Issues

By: Sarfaraz Niazi

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Handbook of Biological Therapeutic Proteins

Regulatory, Manufacturing, Testing, and Patent Issues

By: Sarfaraz Niazi

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413

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CRC Press

Published Date

ISBN 10

1003860206

ISBN 13

9781003860204

Handbook of Pharmaceutical Manufacturing Formulations - 6 Volume Set

By: Sarfaraz K. Niazi

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Handbook of Pharmaceutical Manufacturing Formulations - 6 Volume Set

By: Sarfaraz K. Niazi

Pharmaceutical formulations remain as much an art today as they have evolved into complex science. With exponential growth of generic formulations, the need for ready formulations has increased. Essentially an authoritative and practical guide to the art and science of formulating drugs, the six-volume handbook contains the Bill of Materials and Manufacturing Directions for over 2000 drug formulations, including a number of biotechnology and patented drugs. The author has painstakingly assembled these volumes from FDA New Drug Applications, patent applications and other sources of generic and proprietary formulations, all supplemented by his 30-plus years of experience in pharmaceutical formulations Each volume of the series is divided into two parts: the section on regulatory and manufacturing guidelines and the section on formulations. The series covers issues related to generic manufacturing of drugs including cGMP compliance, pre-approval inspections, stability testing, bioequivalence testing, packaging commodity development, changes to aNDAs, SUPAC for equipment, and a large number of other relevant and current topics of interest to the pharmaceutical industry. Each category of drug formulations, classified in separate volumes, is analyzed for the common difficulties in formulating drugs. This book is the first of its kind published in the pharmaceutical literature and is a must collection for all pharmaceutical manufacturers, educational institutions, and regulatory authorities. Companies with large formulation teams will find this book an excellent platform for benchmarking their own products and generic companies will find this book an excellent source of information prior to embarking on formulating drugs coming off patent; this book will make the difference in the filing of the aNDAs in the shortest possible time. This book is also an excellent teaching tool, not only for those working in the manufacturing environment but also in academia.

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2836

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CRC Press

Published Date

ISBN 10

0849317525

ISBN 13

9780849317521

Handbook of Pharmaceutical Manufacturing Formulations

Over-the-Counter Products (Volume 5 of 6)

By: Sarfaraz K. Niazi

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Handbook of Pharmaceutical Manufacturing Formulations

Over-the-Counter Products (Volume 5 of 6)

By: Sarfaraz K. Niazi

The fifth volume in the series, this book covers over-the-counter products, which include formulations of products classified by the US FDA under the OTC category. Each entry begins with a fully validated scaleable manufacturing formula and a summary of manufacturing process. The book provides a detailed discussion on the difficulties encountered in formulating and manufacturing OTC products. The section on regulatory and manufacturing guidance deals with the topics of cGMP practices for the OTC drug products, formulations of solid oral dosage forms, oral solutions and suspensions, validation of cleaning process, in addition to providing quick tips on resolving the common problems in formulating OTC drugs.

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337

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CRC Press

Published Date

ISBN 10

0849317509

ISBN 13

9780849317507

Book's by SARFARAZ K. NIAZI

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