Metabolism of the drug and its subsequent pharmacokinetics (Absorption, Distribution, Metabolism, and Excretion) are considered as crucial disciplines of the drug discovery and development process. Bioanalytical testing involves determination of the drug metabolism and its pharmacokinetic functioning to deal with the quantification of the drug across the biological matrices including urine, plasma, and tissue samples.
This quantitative measurement involves determining both the pharmacokinetics and pharmacodynamics. Pharmacokinetics services bioanalysis assays are employed in the determination of the interested drug concentration at the moment of collecting the samples for analysis.
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Understanding the concept of Pk bioanalysis –
Bioanalysis is universally defined term for describing the quantification of the drug candidate under analysis. There are two prime components of any bioanalytical method – sample preparation and compound detection.
Sample Preparation –
This is a technique meant for cleaning a sample prior to be subjected for analysis. Usually, this is accomplished for improvising on the interested compound detection. The presence and determination of the drug concentrations in the biological fluids helps in assessing its plasma Pk values.
Compound Detection –
The compound is then detected using a specific detector called the mass spectrometer. At present, the routinely employed technique for quantitative bioanalysis is HPLC-MS/MS either through the use of ESI (Electrospray Ionization) or the APCI (Atmospheric Pressure Chemical Ionization). Prior to implementing any of the bioanalytical method for routine use, its wide scale applicability should be determined for demonstrating its efficacy for all the intended purposes.
This can be easily sufficed if the method is regulated in accordance with the good laboratory practise principles. FDA further recommends that at least 8 of thee following parameters should be evaluated for quantifying the bioanalytical procedure –sensitivity, selectivity, accuracy, precision, robustness, rigidity, limit of quantitation, and limit of detection.
Validation is important for establishing a linear relationship of pharmacokinetics vs pharmacodynamics. Validating a bioanalytical method involves documenting the efforts through the application of specific laboratory investigations that are both suitable and reliable for their intended analytical application.
Pre-clinical bioanalysis –
No sooner the lead drug candidate has been identified, it is subjected to an extensive pre-clinical bioanalysis so as to subject the drug candidate to be tested in humans. The preliminary objective of this analysis is to determine a product’s safety and efficacy profiling. Every class of drug candidates are subjected to different bioanalytical testing such as pharmacodynamics, pharmacokinetic testing, toxicity testing, ADME profiling etc.
In pharmaceutical industry, the term toxicokinetics usually denotes the pharmacokinetic profiling of a lead drug candidate for assessing the dose levels used in different toxicokinetic screening of a potent drug candidate. The preliminary aim of such toxicokinetic drug evaluation are –
Defining a dose-response relationship between the administered dose and its systemic exposure to the targeted organ
It provides sufficient information regarding the time dependencies and their potential dose along the kinetics. Fildena 100 mg, Cenforce 100 mg and Fildena 150 mg is the Best cure for Erectile Dysfunction.
For determining the effect of the PK age across the animal models.
Clinical stages –
Clinical trials are employed in the judgement of both the safety and efficacy profiling of the potent drug candidate. The process of drug discovery and development comprises of four key stages – Stage 1, 2, 3 and 4 where every stage constitutes an important junction of the drug development cycle.