Pharmaceutical Science

Regulations & Standards

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

Diana M. Bowman, Elen Stokes, Arie Rip
October 30, 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

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

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

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

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

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...

Safety Concerns for Herbal Drugs

Divya Vohora, S. B. Vohora
November 24, 2015

Are herbal drugs totally devoid of adverse effects when used alone, as herbal formulations, or in concurrent use with modern medicines? Safety Concerns for Herbal Drugs examines that question and others like it to give you the information you need to judge for yourself the balance between the risks...

Writing and Managing SOPs for GCP

Susanne Prokscha
July 29, 2015

Writing and Managing SOPs for GCP is the first book to discuss managing Standard Operating Procedures (SOPs) for Good Clinical Practice (GCP) from conception to retirement. It recommends approaches that have a direct impact on improving SOP and regulatory compliance. Throughout the text, the book...

EU Annex 11 Guide to Computer Validation Compliance for the Worldwide Health Agency GMP

Orlando Lopez
April 06, 2015

Good Manufacturing Practice (GMP) ensures medicinal products are produced consistently and controlled to the quality standards appropriate for their intended use and as required by product specifications or marketing authorization. Annex 11 details the European Medicines Agency (EMA) GMP...

Handbook of Bioequivalence Testing, Second Edition

Sarfaraz K. Niazi
October 29, 2014

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...

FDA Regulatory Affairs: Third Edition

David Mantus, Douglas J. Pisano
February 28, 2014

FDA Regulatory Affairs is a roadmap to prescription drug, biologics, and medical device development in the United States. Written in plain English, the concise and jargon-free text demystifies the inner workings of the US Food and Drug Administration (FDA) and facilitates an understanding of how...

Generic Drug Product Development: Solid Oral Dosage Forms, Second Edition

Leon Shargel, Isadore Kanfer
October 24, 2013

In this era of increased pharmaceutical industry competition, success for generic drug companies is dependent on their ability to manufacture therapeutic-equivalent drug products in an economical and timely manner, while also being cognizant of patent infringement and other legal and regulatory...

Conferences

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