Pharmaceutical Science

Regulations & Standards

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Good Manufacturing Practices for Pharmaceuticals, Seventh Edition

7th Edition

Featured

Graham P. Bunn
February 18, 2019

This book provides insight into the world of pharmaceutical quality systems and the key elements that must be in place to change the business and organizational dynamics from task-oriented procedure-based cultures to truly integrated quality business systems that are self-detecting and correcting. C...

Innovative Statistics in Regulatory Science

1st Edition

Shein-Chung Chow
November 07, 2019

Statistical methods that are commonly used in the review and approval process of regulatory submissions are usually referred to as statistics in regulatory science or regulatory statistics. In a broader sense, statistics in regulatory science can be defined as valid statistics that are employed in...

Design Controls for the Medical Device Industry, Third Edition

3rd Edition

Marie B. Teixeira
August 15, 2019

This third edition provides a substantial comprehensive review of the latest design control requirements, as well as proven tools and techniques to ensure a company's design control program evolves in accordance with current industry practice. It assists in the development of an effective design...

The Pharmaceutical Regulatory Process

2nd Edition

Ira R. Berry, Robert P. Martin
June 07, 2019

This Second Edition examines the mechanisms and means to establish regulatory compliance for pharmaceutical products and company practices. It focuses on major legislative revisions that impact requirements for drug safety reviews, product regulatory approvals, and marketing practices. Written by...

Good Manufacturing Practices for Pharmaceuticals, Seventh Edition

7th Edition

Graham P. Bunn
February 18, 2019

This book provides insight into the world of pharmaceutical quality systems and the key elements that must be in place to change the business and organizational dynamics from task-oriented procedure-based cultures to truly integrated quality business systems that are self-detecting and correcting....

Pharmaceutical and Medical Devices Manufacturing Computer Systems Validation

1st Edition

Orlando Lopez
October 02, 2018

Validation of computer systems is the process that assures the formal assessment and report of quality and performance measures for all the life-cycle stages of software and system development, its implementation, qualification and acceptance, operation, modification, requalification, maintenance...

Regulatory Toxicology, Third Edition

3rd Edition

Shayne C. Gad
August 01, 2018

This practical book provides toxicologists with essential information on the regulations that govern their jobs and products. Regulatory Toxicology, Third Edition is an up-to-date guide to required safety assessment for the entire range of man-made marketed products. Individual chapters written by...

Biosimilarity: The FDA Perspective

1st Edition

Sarfaraz K. Niazi
July 25, 2018

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...

Handbook of Medical Device Regulatory Affairs in Asia: Second Edition

2nd Edition

Jack Wong, Raymond Tong
April 20, 2018

Medical device regulation in Asia has gained more importance than ever. Governments and regulatory bodies across the region have put in place new regulatory systems or refined the existing ones. A registered product requires a lot of technical documentation to prove its efficacy, safety, and...

Chromatographic Techniques in the Forensic Analysis of Designer Drugs

1st Edition

Teresa Kowalska, Mieczyslaw Sajewicz, Joseph Sherma
February 06, 2018

There is a dramatic rise of novel drug use due to the increased popularity of so-called designer drugs. These synthetic drugs can be illegal in some countries, but legal in others and novel compounds unknown to drug chemistry emerge monthly. This thoughtfully constructed edited reference presents...

Measuring Elemental Impurities in Pharmaceuticals: A Practical Guide

1st Edition

Robert Thomas
February 02, 2018

Recent regulations on heavy metal testing have required the pharmaceutical industry to monitor a suite of elemental impurities in pharmaceutical raw materials, drug products and dietary supplements. These new directives s are described in the new United States Pharmacopeia (USP) Chapters <232>...

Embedding New Technologies into Society: A Regulatory, Ethical and Societal Perspective

1st Edition

Diana M. Bowman, Elen Stokes, Arie Rip
September 11, 2017

The embedding of any new technologies in society is challenging. The evolving state of the scientific art, often-unquantifiable risks and ill-defined developmental trajectories have the potential to hinder innovation and/or the commercial success of a technology. The are, however, a number of tools...

The Delivery of Regenerative Medicines and Their Impact on Healthcare

1st Edition

Catherine Prescott, Dame Julia Polak
June 14, 2017

Now that prohibitions against stem cell research are relaxing, it is time for the field to move forward with the advances that promise to eliminate so much human suffering. However, it would be naïve to ignore the fact that regenerative medicines pose a whole new set of challenges to an industry...

Conferences

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