**1. Introduction**

This chapter represents a collective attempt to present a wide range of analytical techniques applied for the clinical development process. Analytical chemistry is concerned with the chemical characterization of matter and refining the qualitative and quantitative problem about that matter. It plays a vital role in almost all the aspects of scientific research and development, for example, clinical, forensic, environmental, and pharmaceutical sciences. In medicine, analytical chemistry is the key for clinical laboratory tests which imparts basis of disease diagnosis and chart progress for recovery to the physicians [1]. **Figure 1** describes the scheme through which physicians ruled out or analyze the disease prognosis and therapeutic drug monitoring in patients. In accord with this, an analytical chemist also explores the idea of developing advanced technique for betterment of human healthcare and in sorting out the problems related to the disease diagnosis. Implementation of an analytical technique mainly depends on the varying degree of selectivity, sensitivity, accuracy, precision, cost, and rapidity of that particular technique. The techniques

#### **Figure 1.**

*Schematic representation of four common decision making steps in which the result of an investigation is involved.*

employed may be based either on physical property or chemical property of an analyte. An analyte is defined as a constituent which has to be determined in a given sample type. The classical analytical techniques include gravimetric, volumetric, and titrimetric methods; on the other hand, instrumental techniques involve ultraviolet-visible (UV-Vis), infrared (IR), and near-infrared (NIR) spectrophotometry fluorimetry, atomic spectroscopy (absorption/emission), electroanalytical chromatography, and radioimmunoassay. Instrumental techniques are usually more sensitive and selective than classical techniques but are less precise. Precision of techniques means the repeatability of a result and is expressed as standard deviation. Selectivity of an analytical method defines the measurement of a particular analyte from sample solution to a certain degree, in the presence of other analytes, without any interference. However, sensitivity of a method describes the ability to recognize two different concentrations.

However, medical and clinical analyses are undergoing the greatest extension of instrumental methods [2]. Interest in identifying biologically active compounds is growing rapidly and providing new challenges for the analytical chemists. These challenges have been resolved by the introduction of bioanalytical technique as a modern approach to disease diagnosis and therapy. A bioanalytical method is a combination of different procedures which are (i) collection, (ii) processing, (iii) storage, and (iv) analysis of a biological sample (blood-cerebrospinal fluid (CSF), serum, plasma, or urine, tissue, and skin). This method is also useful for quantitative determination of drugs and metabolites in biological samples. For that reason, technologies used to perform bioanalytical methods vary according to the analyte's nature. Hence, to find out the appropriate technologies involved in a bioanalytical method for the purpose of quantification of an analyte, the method validation is important. This procedure is termed as bioanalytical method validation (BMV). Few techniques commonly applied in bioanalytical studies include hyphenated (combination of two techniques) techniques like liquid chromatography (LC), gas chromatography (GC), capillary electrophoresis (CE) coupled with mass spectrometry (MS), and advanced automated chromatographic techniques, for example, high-performance liquid chromatography (HPLC) [3].

During the past decades, the analytes that have been targeted in bioanalytical studies include amino acid, peptides, proteins, serum enzyme, tumor and cancer genes, carbohydrates, vitamins, catecholamines, cardiac risk factors, etc. [4].

**31**

*Advancement in Analytical and Bioanalytical Techniques as a Boon to Medical Sciences*

With the recurrent analysis of biomolecules, numerous analytical techniques and instrumentation have been evolved and applied in the field of medical sciences

Biological samples have the potential to deliver important biomarkers in the clinic due to accessibility of these biological materials. In clinical development, the most important benefit offered by biomarkers is to limit investigational drugs to critical care patients who would gain the therapies to observe the effectiveness of those drugs [5]. The role of a biomarker is to give information about the biological mechanism involved within a disease or treatment of disease having the capability to correlate with the clinical findings. One of the most tangible problems that research scientists are facing in recent years is finding disease biomarkers that are translated well from animal or computer simulation to humans. For example, increase in enzyme activity in computer or animal model may have a significant impact in theoretical computer or animal model, whereas same enzyme activity

There is no denying that "analytical and bioanalytical technique" is a broad topic, incorporating technologies from classical chromatography to point-of-care instrumentation. But unifying and doing them as quickly, accurately, and inexpensively as possible are drives to make chemical or biochemical measurements. Over the preceding sections, we would study the technological improvements along those lines across the broad field of analytical methods. Every subsection of analytical techniques applied in medical field has experienced improvement and advancement as well. Researchers are interested in mapping the neural connectivity of the brain through scanning electron microscopy (SEM). This could be now employed with more powerful microscopes, such as focused ion beam and multi-beam SEM, to collect serial images of ultrathin brain slices [6]. They can now build surface plasmon resonance substrates out of silver rather than the more typical gold and an SPR microscope to image and quantify 1296 binding events in parallel [7]. Those scientists who are interested in surface properties can now scan those surfaces faster

We have to keep in mind that biological samples, collected from the patients,

must be transported to the initial assessment center as soon as possible.

*DOI: http://dx.doi.org/10.5772/intechopen.80279*

which are as follows:

• Electrophoresis

• Chromatography

• Mass spectrometry

• Hyphenated techniques

• Point-of-care instrumentation

• Optical techniques (microscopy)

• Radio- and immunochemical techniques

enhancement may have a very limited or no clinical impact.

than ever, thanks to high-speed atomic force microscopy [8].

**2. Sample collection and storage**

• Sensors

*Advancement in Analytical and Bioanalytical Techniques as a Boon to Medical Sciences DOI: http://dx.doi.org/10.5772/intechopen.80279*

With the recurrent analysis of biomolecules, numerous analytical techniques and instrumentation have been evolved and applied in the field of medical sciences which are as follows:

• Sensors

*Biochemical Testing - Clinical correlation and Diagnosis*

recognize two different concentrations.

employed may be based either on physical property or chemical property of an analyte. An analyte is defined as a constituent which has to be determined in a given sample type. The classical analytical techniques include gravimetric, volumetric, and titrimetric methods; on the other hand, instrumental techniques involve ultraviolet-visible (UV-Vis), infrared (IR), and near-infrared (NIR) spectrophotometry fluorimetry, atomic spectroscopy (absorption/emission), electroanalytical chromatography, and radioimmunoassay. Instrumental techniques are usually more sensitive and selective than classical techniques but are less precise. Precision of techniques means the repeatability of a result and is expressed as standard deviation. Selectivity of an analytical method defines the measurement of a particular analyte from sample solution to a certain degree, in the presence of other analytes, without any interference. However, sensitivity of a method describes the ability to

*Schematic representation of four common decision making steps in which the result of an investigation is* 

However, medical and clinical analyses are undergoing the greatest extension of instrumental methods [2]. Interest in identifying biologically active compounds is growing rapidly and providing new challenges for the analytical chemists. These challenges have been resolved by the introduction of bioanalytical technique as a modern approach to disease diagnosis and therapy. A bioanalytical method is a combination of different procedures which are (i) collection, (ii) processing, (iii) storage, and (iv) analysis of a biological sample (blood-cerebrospinal fluid (CSF), serum, plasma, or urine, tissue, and skin). This method is also useful for quantitative determination of drugs and metabolites in biological samples. For that reason, technologies used to perform bioanalytical methods vary according to the analyte's nature. Hence, to find out the appropriate technologies involved in a bioanalytical method for the purpose of quantification of an analyte, the method validation is important. This procedure is termed as bioanalytical method validation (BMV). Few techniques commonly applied in bioanalytical studies include hyphenated (combination of two techniques) techniques like liquid chromatography (LC), gas chromatography (GC), capillary electrophoresis (CE) coupled with mass spectrometry (MS), and advanced automated chromatographic techniques,

for example, high-performance liquid chromatography (HPLC) [3].

During the past decades, the analytes that have been targeted in bioanalytical studies include amino acid, peptides, proteins, serum enzyme, tumor and cancer genes, carbohydrates, vitamins, catecholamines, cardiac risk factors, etc. [4].

**30**

**Figure 1.**

*involved.*


Biological samples have the potential to deliver important biomarkers in the clinic due to accessibility of these biological materials. In clinical development, the most important benefit offered by biomarkers is to limit investigational drugs to critical care patients who would gain the therapies to observe the effectiveness of those drugs [5]. The role of a biomarker is to give information about the biological mechanism involved within a disease or treatment of disease having the capability to correlate with the clinical findings. One of the most tangible problems that research scientists are facing in recent years is finding disease biomarkers that are translated well from animal or computer simulation to humans. For example, increase in enzyme activity in computer or animal model may have a significant impact in theoretical computer or animal model, whereas same enzyme activity enhancement may have a very limited or no clinical impact.

There is no denying that "analytical and bioanalytical technique" is a broad topic, incorporating technologies from classical chromatography to point-of-care instrumentation. But unifying and doing them as quickly, accurately, and inexpensively as possible are drives to make chemical or biochemical measurements. Over the preceding sections, we would study the technological improvements along those lines across the broad field of analytical methods. Every subsection of analytical techniques applied in medical field has experienced improvement and advancement as well.

Researchers are interested in mapping the neural connectivity of the brain through scanning electron microscopy (SEM). This could be now employed with more powerful microscopes, such as focused ion beam and multi-beam SEM, to collect serial images of ultrathin brain slices [6]. They can now build surface plasmon resonance substrates out of silver rather than the more typical gold and an SPR microscope to image and quantify 1296 binding events in parallel [7]. Those scientists who are interested in surface properties can now scan those surfaces faster than ever, thanks to high-speed atomic force microscopy [8].

#### **2. Sample collection and storage**

We have to keep in mind that biological samples, collected from the patients, must be transported to the initial assessment center as soon as possible.

The type of preservatives should be known to protect the samples from degradation prior to cryopreservation at a reasonable cost. Cryopreservation is a process to store biological samples at very low temperature for prevention of damage. The purpose is to find readily accessible and data-rich biological samples. The stability of a wide range of bioanalytes and cells as a component of whole blood should be estimated, taking into account different anticoagulant (inhibition of coagulation of blood) media, at different temperatures and under varying transport conditions. Bioanalytes can be known biochemicals, such as DNA, defined proteins, and specific metabolites, or unknown analytes, such as the constituent plasma/serum proteome and metabonome [9].

Design and testing of the sample handling protocol considered as key factors that affect the stability of biological samples, including anticoagulants, stabilizing agents, and temperature, elapsed time from collection to initial processing and endogenous degrading properties (enzymes, cell death). We also aim for cost-efficiency by avoiding collecting multiple sources of material for the same analyte. The samples undergo minimal processing locally in the assessment centers before being shipped to the main laboratory for processing with the aim of cryopreservation within 24 h of collection. Samples are protected against degradation during shipping by being chilled at 4°C (only peripheral blood lymphocytes, at 18°C). Once the samples get processed in the laboratory, they are placed in cabinets maintained at −80°C for the working archive or in nitrogen vapor at −180°C or below for the backup archive.
