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Solid Oral Dose Process Validation

in solid dose pharmaceutical manufacturing. All approaches meet the regulatory requirements enlisted in the guidance's, which is the precursor to;

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Pharmaceutical Analysis for Small Molecules

A comprehensive introduction for scientists engaged in new drug development, analysis, and approvals Each year the pharmaceutical;

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The Pharmaceutical Regulatory Process

This Second Edition examines the mechanisms and means to establish regulatory compliance for pharmaceutical products and company practices;

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The Politics of Pharmaceutical Policy Reform

regulatory reform. This is particularly intriguing because a regulatory shift in the pharmaceutical sector requires the participation of a number;

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Solid Oral Dose Process Validation, Volume Two

The textbook addresses the lifecycle concepts (Stage 1, 2, 3) of Process Validation. Regulatory bodies such as US FDA, EMEA, WHO, PIC/S;

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Toxicology and Regulatory Process

presents the latest information on the impact of toxicology on the regulatory process and illustrates the interrelationship between toxicology and;

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Innovative Statistics in Regulatory Science

that are employed in the review and approval process of regulatory submissions of pharmaceutical products. In addition, statistics;

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Innovative Statistics in Regulatory Science

that are employed in the review and approval process of regulatory submissions of pharmaceutical products. In addition, statistics;

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Toxicology and Regulatory Process

presents the latest information on the impact of toxicology on the regulatory process and illustrates the interrelationship between toxicology and;

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How to Validate a Pharmaceutical Process

process validation program. The latest volume in the Expertise in Pharmaceutical Process Technology Series, this book illustrates the methods and;

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The Clinical Research Process in the Pharmaceutical Industry

personnel. It is the conceptual framework involving the philosophical, economic, political, historical, regulatory, planning, and marketing aspects;

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Statistics in the Pharmaceutical Industry

Pharmaceutical Industry, Third Edition demystifies the approval process by combining regulatory and industrial points of view, making it a must-read for;

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New Drug Approval Process

in filing US and global INDs, NDAs, BLAs, ANDAs, and SNDAs the latest regulatory requirements for expediting new drug approvals strategies for;

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The Clinical Research Process in the Pharmaceutical Industry

personnel. It is the conceptual framework involving the philosophical, economic, political, historical, regulatory, planning, and marketing aspects;

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Multivariate Analysis in the Pharmaceutical Industry

Multivariate Analysis in the Pharmaceutical Industry provides industry practitioners with guidance on multivariate data methods and;

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Pharmaceutical Regulatory Affairs

more. Lost in a sea of acronyms? Weve got you covered. Not really sure how regulatory fits into pharmaceutical development? We explain the;

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Pharmaceutical Process Scale-Up

The third edition of Pharmaceutical Process Scale-Up deals with the theory and practice of scale-up in the pharmaceutical industry. This;

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Pharmaceutical Manufacturing Handbook

analytical technology, this handbook offers complete coverage of the regulations and quality control issues that govern pharmaceutical manufacturing;

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Automation Applications in Bio-pharmaceuticals

This book is a guide for engineers and designers new to the field of bio-pharmaceutical process control. For the experienced automation;

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Chitosan in Drug Delivery

, emphasizing recent advances in the field as written by academic, industry and regulatory scientists. It will be a useful resource for pharmaceutical;

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Pharmaceutical Biotechnology: Fundamentals and Applications, Third Edition

oligonucleotides, siRNA and various monoclonal antibodies, immunogenicity, gene therapy, and the regulatory issues factoring into the biopharmaceutical;

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Advances and Challenges in Pharmaceutical Technology

advancements in pharmaceutical technology. The book discusses common formulation strategies, including the use of tools for statistical formulation;

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Handbook of Pharmaceutical Granulation Technology

This fully revised edition of Handbook of Pharmaceutical Granulation Technology covers the rapid advances in the science of agglomeration;

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Pharmaceutical Quality by Design

Pharmaceutical Quality by Design: Principles and Applications discusses the Quality by Design (QbD) concept implemented by regulatory;

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Validation of Pharmaceutical Processes

Completely revised and updated to reflect the significant advances in pharmaceutical production and regulatory expectations, this third;

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Computer-Aided Applications in Pharmaceutical Technology

Research and development in the pharmaceutical industry is a time-consuming and expensive process, making it difficult for newly developed;

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Formulation And Process Development Strategies For Manufacturing Biopharmaceuticals

fractions. And it offers the perspective and experience of production and manufacturing of the drugs, making this a vital for pharmaceutical;

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