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Pharmaceutical Industry Practices on Genotoxic Impurities

pharmaceutical industry today. Pharmaceutical Industry Practices on Genotoxic Impurities strives to facilitate scientific and systematic consensus on GTI;

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Genotoxic Impurities

This book examines genotoxic impurities and their impact on the pharmaceutical industry. Specific sections examine this from both a;

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Characterization of Impurities and Degradants Using Mass Spectrometry

The book highlights the current practices and future trends in structural characterization of impurities and degradants. It begins with an;

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Mutagenic Impurities - Strategies for Identification and Control

impact on the pharmaceutical industry. The book incorporates the adoption of the ICH M7 guideline and focuses on mutagenic impurities from both a;

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Pharmaceutical Analysis for Small Molecules

Due to global nature of pharmaceutical industry, other topics on both regulatory (ICH) and Compendial harmonization are also highlighted;

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Measuring Elemental Impurities in Pharmaceuticals

Recent regulations on heavy metal testing have required the pharmaceutical industry to monitor a suite of elemental impurities;

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Measuring Elemental Impurities in Pharmaceuticals

Recent regulations on heavy metal testing have required the pharmaceutical industry to monitor a suite of elemental impurities;

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Specification of Drug Substances and Products: Development and Validation of Analytical Methods

and critical analysis of the requirements and approaches to setting specifications for new pharmaceutical products, with an emphasis on phase;

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Sources of Contamination in Medicinal Products and Medical Devices

in medicinal products often focus on analytical methods for detecting nonspecific impurities. Key to the work of the pharmaceutical chemist, this;

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GMP in Pharmaceutical Industry

practices in pharmaceutical industry. The purpose of this handbook is to provide easily accessible knowledge about the pharmaceutical industry and;

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Analysis of Drug Impurities

A key component of the overall quality of a pharmaceutical is control of impurities, as their presence, even in small amounts, may affect;

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Supercritical Fluid Chromatography

Analytical chemists in the pharmaceutical industry are always looking for more-efficient techniques to meet the analytical challenges;

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Modern Pharmaceutical Industry

thorough analysis of its practices and procedures. Modern Pharmaceutical Industry is a valuable resource for all pharmacy students, new;

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Good Manufacturing Practices for Pharmaceuticals

and changing practices in CGMP regulation and pharmaceutical manufacturing and control practices worldwide. An essential companion for every;

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Bayesian Applications in Pharmaceutical Development

physicians working in the pharmaceutical industry and regulatory agencies Covers broad Bayesian topics on designs, analyses, and reporting;

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The Pharmaceutical Regulatory Process

practices. Written by top industry professionals, practicing attorneys, and FDA regulators, it includes policies and procedures that pharmaceutical;

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Overdose

An analysis of how we regulate the pharmaceutical industry: are we protecting patients or blocking the development of useful new drugs;

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Accelerated Predictive Stability (APS)

Accelerated Predictive Stability (APS): Fundamentals and Pharmaceutical Industry Practices provides coverage of both the fundamental;

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Principles Of Process Research And Chemical Development In The Pharmaceutical Industry

principles of chemical development; techniques for the minimization of by-product impurities; criteria for cost-effective synthesis of enantiopure;

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Thresholds of Genotoxic Carcinogens

, the US, and Europe on the subject of genotoxic thresholds. In regulation, it is an adage that genotoxic carcinogens have no thresholds for;

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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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Devalued and Distrusted

An expert's view on solving the challenges confronting today's pharmaceutical industry Author John LaMattina, a thirty-year veteran of the;

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Good Manufacturing Practices for Pharmaceuticals, Seventh Edition

: Presents insight into the world of pharmaceutical quality systems Analyzes regulatory trends and expectations Includes approaches and practices;

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Pharmaceutical Ethics

Pharmaceutical Ethics is an important text, which aims to provide the ethical guidelines much needed by the pharmaceutical industry. By;

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Pharmaceutical Economics and Policy

The pharmaceutical industry is praised as a world leader in high technology innovation and the creator of products that increase both;

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Pharmapolitics in Russia

Over the last one hundred years, the Russian pharmaceutical industry has undergone multiple dramatic transformations, which have taken;

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Pharmaceutical Regulatory Environment

This book compares national and centralised procedure practices and key performance metrics, including current approval times, review;

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