Pharmaceutical Science

Regulations & Standards

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Pharmaceutical and Medical Devices Manufacturing Computer Systems Validation

1st Edition

Orlando Lopez
September 19, 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

The focus of this book is on how the US FDA will approve biosimilar drugs. The European scene is well developed with specific guidelines that are already in place. However, these guidelines do not apply to the thinking of the FDA in approving these products. The FDA is quite different from other...

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...

Introduction to Market Access for Pharmaceuticals

1st Edition

Mondher Toumi
January 04, 2017

Market access is the fourth hurdle in the drug development process and the primary driver for global income of any new drug. Without a strategy in place for pricing, showing value for effectiveness and an understanding of the target purchasers’ needs, the drug will fail to reach its intended market...

Data Integrity in Pharmaceutical and Medical Devices Regulation Operations: Best Practices Guide to Electronic Records Compliance

1st Edition

Orlando Lopez
October 21, 2016

Data integrity is fundamental in a pharmaceutical and medical devices quality system. This book provides practical information to enable compliance with data integrity, while highlighting and efficiently integrating worldwide regulation into the subject. The ideas presented in this book are based...

Regulatory and Pharmacological Basis of Ayurvedic Formulations

1st Edition

Amritpal Singh
June 14, 2016

Regulatory affairs and pharmacological drug safety issues of Ayurvedic medicine has been overlooked by practitioners for many years. Research in Ayurveda is now a world-wide phenomenon, and several large pharmaceutical corporations are investing money for novel drug discovery from Ayurvedic sources...

Pharmaceutical Product Development: Insights Into Pharmaceutical Processes, Management and Regulatory Affairs

1st Edition

Vandana B. Patravale, John I. Disouza, Maharukh Rustomjee
March 03, 2016

Pharmaceutical product development is a multidisciplinary activity involving extensive efforts in systematic product development and optimization in compliance with regulatory authorities to ensure the quality, efficacy and safety of resulting products. Pharmaceutical Product Development equips the...

Conferences

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