This book guides the reader through FDA regulation guidelines and outlines a comprehensive strategy for cost reduction in regulatory affairs and compliance. This book explains six strategies to cost-effectively comply with FDA regulations while maintaining product safety and improving public...

A must-have guide for any professional in the drug manufacturing industry The Good Clinical Practice (GCP) audit is a tedious but necessary exercise that assures that all parties do their job properly and in compliance with the applicable FDA code. Clinical Trials Audit Preparation demystifies...

Pharmaceutical and Biomedical Portfolio Management in a Changing Global Environment explores some of the critical forces at work today in the complex endeavour of pharmaceutical and medical product development. Written by experienced professionals, and including real-world approaches and best...

Biodiversity -- Contents -- 1 Natural Products - History, Diversity and Discovery -- Microbial Natural Products: A Past with a Future -- New Concepts and Approaches to Biodiversity -- Natural Products Drug Discovery at the National Cancer Institute. Past Achievements and New Directions for the...

In India today only 35 percent of people have access to medicines. This book examines the rise of drug prices in India, and develops a new healthcare model, which if implemented, would extend access to medicines to India's entire population. Sensitivity tests show that the proposed model is...

This book modifies the existing economic theory of health analysis by integrating the issues and principles of moral philosophy in an extended framework. It also develops some operational mathematical models to show how this framework can be applied to health economics and policy evaluation.