Analytical techniques involved in Analysis of Drugs

Abstract

Biomolecules or macromolecules such as proteins or hormones, either produced by isolation from biological sources or by means of biotechnology, must also be subjected to careful analytical control. Thus, while the analytical tasks required for biomolecules are somewhat different from those of ordinary pharmaceuticals, when it comes to regulation and documentation of their quality and properties they definitely belong to the same group. The development of drugs in the pharmaceutical industry is a long-term process, often taking more than a decade from the start of the research project to appearance of a drug on the market especially the IND and NDA, the amount of data generated is enormous. Analytical chemists take part in many of the studies that constitute this documentation. Substance quality and its specifications are based on substance analysis, and that knowledge is later used for quality control during full-scale production.

Keywords

Biomolecules, Macromolecules, Ordinary pharmaceuticals, Regulation, Analytical chemists, Documentation

Introduction

Pharmaceutical analysis is traditionally defined as analytical chemistry dealing with drugs both as bulk drug substances and as pharmaceutical products (formulations). However, in academia, as well as in the pharmaceutical industry, other branches of analytical chemistry are also involved, viz. bio analytical chemistry, drug metabolism studies, and analytical biotechnology. The development of drugs in the pharmaceutical industry is a long-term process, often taking more than a decade from the start of the research project to appearance of a drug on the market. That process involves several decision points, such as the choice of the candidate drug after the discovery phase, the application to the authorities before testing the compound for the first time in humans, and finally the new drug application for marketing, which summarizes the data obtained from all the studies needed for approval of the drug as a medicine. In all these steps the amount of data generated is enormous. Analytical chemists are involved in many of the studies that constitute this documentation. Substance quality and its specifications are based on substance analysis, and that knowledge is later used for quality control (QC) of the substance during full-scale production. Product analysis involves dealing with the various formulations used for toxicological studies, clinical studies, and marketing. The results from such work lead to specifications that form the basis for the QC of the product. For both substances and formulations there is an increasing interest in the introduction of process analytical chemistry.

Biomolecules, i.e., macromolecules such as proteins or hormones, either produced by isolation from biological sources or by means of biotechnology, must also be subjected to careful analytical control. Thus, while the analytical tasks required for biomolecules are somewhat different from those of ordinary pharmaceuticals, when it comes to regulation and documentation of their quality and properties they definitely belong to the same group.

There are a number of regulations that have to be followed in the development of pharmaceuticals as well as in their production. Regulatory approval is required prior to each clinical trial and before marketing is licensed. That process involves several decision points, such as the choice of the candidate drug after the preclinical screening phase, the investigational new drug (IND) application before testing the compound for the first time in man, and finally the new drug application (NDA) which summarizes the data obtained from all the studies needed for marketing approval of the drug as a medicine. In all these steps, especially the IND and NDA, the amount of data generated is enormous. Analytical chemists take part in many of the studies that constitute this documentation. Substance quality and its specifications are based on substance analysis, and that knowledge is later used for quality control during full-scale production.

There are a number of regulations that have to be followed in the development of pharmaceuticals as well as in their production. Regulatory approval is required prior to the IND and before marketing is licensed (NDA). Today clinical trials also undergo scrutiny by the authorities. This article provides an overview of mainly substance and product analysis (traditional pharmaceutical analysis), as used in the pharmaceutical industry. The support of other branches of analytical chemistry will be mentioned.