Bio-Analytical Method Validation-A Review

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Austin J Anal Pharm Chem. 2015; 2(5): 1053.

Bio-Analytical Method Validation-A Review

Taleuzzaman M¹*, Gilani SJ¹, Ali S¹, Hafeez A¹ and Nagarajan K²

¹Glocal School of Pharmacy, Glocal University, Saharanpur, U.P.247121, India

²KIET School of Pharmacy, 13 Km. Stone, Ghaziabad- Meerut Road, Ghaziabad-201206, India

*Corresponding author: Mohamad Taleuzzaman, Glocal School of Pharmacy, Glocal University, Saharanpur, U.P.247121, India.

Received: November 02, 2015; Accepted: December 04, 2015; Published: December 07, 2015

Abstract

Validation is a basic requirement to ensure quality and reliability of method development in analytical and bio-analytical process. Bio-analytical method development is very important during the process of drug discovery and development for marketing approval. The purpose of this review is to discuss about the step involved in validation and provide a practical approach for determining the different parameters like selectivity, specifity, limit of detection, lower limit of quantitation, linearity, range, accuracy, precision, recovery, stability, ruggedness, and robustness to help the perfect studies of pharmacokinetic, toxic kinetic, bioavailability and bioequivalence. Bio-analysis study is for the quantitative determination of drug and their metabolites in biological fluids. Accurate and robust methods for quantitative analysis of drug and their metabolites are important for the successful conduct of pre-clinical, bio-pharmaceutics and clinical pharmacology.

Keywords: Bio-analytical method development; Validation parameters; Documentation

Introduction

Bio-analytical validation is a detailed description of different steps necessary to perform the developed methods [1-5]. Method development and validation has a great importance in the field of pharmacokinetic (PK), bioavailability (BA) and bioequivalence (BE) studies for new drug approval and investigation by regulatory bodies [6-8]. Bio-analysis of drugs and its metabolites study is very important for the drug efficacy, side effect and bioavailability of drug. A robust method also need for the forensic and toxicological interpretation. The quality of toxicological studies data can be made more accurate by following an accurate and robust method development and validation. In forensic and clinical toxicological studies bio-analysis method play a very important role to find the exact and accurate cause of concerns [9-10]. Bio-analytical method validation is performed according to the ICH guidelines which come under Q2A and Q2B [11-13]. A full and final robust method is applied for the routine analysis. It is highly true I respect of quality management and accreditation, which have become matters of increasing importance in analytical toxicology in the recent years [14-16]. This is also reflected in the increasing requirements of peer-reviewed scientific journals concerning method validation. Therefore, this topic should extensively be discussed on an international level to reach a consensus on the extent of validation experiments and on acceptance criteria for validation parameters of bio-analytical methods in forensic (and clinical) toxicology [17,18].

Demand of Bioanalytical Method Validation

Bio-analytical method validation or bio-analysis of drug has its own value which will depend upon analytes nature and technology which use for the method development and validation. A reliable and reproducible methods and techniques are always very demanding for the drugs and its metabolites studies for bioavailability (BA), bioequivalence (BE) and pharmacokinetic (PK) parameter for conducting the pre clinical studies [19-21]. A perfect approach to reach the drugs and its metabolites best efficacy and side effects value can be known by the accurate and sensitive method development and validation. In respect of economy and market demand the chief and best bio-analytical methods are adopted for routine analysis [22].

Bioanalytical Method Validation

In bio-analytical method validation different types and levels are come which must be need to understand basic requirement in the process. Here all types are defined in very specific manner.

A. Full Validation

B. Partial Validation

C. Cross Validation

A. Full Validation: After developing a new method for new drug need to validate the entire step as per the ICH guidelines. It is very important for the new drug and also if metabolites are exits with drug.

B. Partial Validation: Modification of full validation bioanalytical method that do not necessarily call for full validation. Modification require in typical bio-analytical method changes are,

C. Cross Validation: Comparison two bio-analytical validation method parameters within the same study or across different studies. Cross validation can be done by reference methods with revised bioanalytical methods. The comparisons should be done in both ways. Cross validation should also be done when data generated using different analytical technique (e.g. LC-MS-MS vs. ELISA) [11,23-25].

Steps of Bioanalytical Validation

1. Development Manual: Documents about company policy and essential requirements for validation should be available.

2. Selection of analytical method and instruments: Selection of analytical method and the instruments depends on the ultimate aim of analysis.

3. Installation qualification (IQ): Documents that indicate that the instrument meets the requirements of the system and ready for installation in accorandance with the standards and specification must be met.

4. Operational qualification (OQ): Verification that the installed system is suitable for intended purpose [12,13,26].

Bioanalytical Validation Parameters

Validation in Bio-analytical method is including [27,28].

Citation: Taleuzzaman M, Gilani SJ, Ali S, Hafeez A and Nagarajan K. Bio-Analytical Method Validation-A Review. Austin J Anal Pharm Chem. 2015; 2(5): 1053. ISSN : 2381-8913