The world of pharmacology and drug development involves two broad ways of biomolecule classifications – large biomolecules and small biomolecules. Apart from its size, these biomolecules are differentiated based on their made, behavior, mode of transportation, and their drug suitability with other drugs. Interestingly, more than 90 percent of the drug molecules available today in the market are small molecules. In contrast, the remaining ones are large molecules.
Since ages, the small molecules have been serving as the basis for the process of drug development. As they have a relatively smaller size, it becomes easier to ingest them through the gastrointestinal tract, where the active substances are quickly absorbed into your bloodstream. These absorbed molecules later possess the ability to get distributed throughout your body. Their small size makes it easier for them to penetrate through any cell membranes.
Large molecules are labeled as the proteins blessed with a therapeutic effect. They have high complexity and are composed of around 1300 amino acids. Most of them are regarded as identical versions of the human proteins. These molecules perform the work of transferring the absorbed drugs to several different locations of the body. Such drugs are developed through complex processes consisting of more than 1000 different steps. They may either be administered in the form of injection or infusion or oral administration. Mostly, large biomolecules are employed in the production of blood, vaccines, blood components, tissues, and gene therapy, etc.
Large Molecule Bioanalysis –
This is a form of an analytical procedure wherein you analyze a large molecule bioanalysis for its therapeutic efficacy. Commonly, the biological matrix employed here is either serum or plasma. Usually, both preclinical and clinical studies are typically used for the pharmacokinetic bioanalysis of both the plasma and serum samples. The preclinical studies involve the dosing of either animals or patients with the investigational drug product. The blood samples are later drawn at frequent time intervals; serum or the plasma is isolated and forwarded to the analytical laboratories. The concentration of the large molecule drugs is analyzed either through the use of ligand binding techniques such as MSD or ELISA.
Preclinical toxicokinetic studies resemble pharmacokinetic studies but with a certain degree of differentiation between them. In the first place, the toxicokinetic studies are accomplished at relatively higher dose ranges, thereby allowing the toxic effect to be more apparent. Toxicokinetic studies help in determining the pharmacokinetics of an investigational compound at the elevated levels of the toxicological studies. The pharmacokinetic study is basically aimed to enhance the efficacy of the drug under study, thereby understanding its clearance and drug bioavailability.
Small Molecule Bioanalysis –
The small molecule bioanalysis is referred to as a chemical analysis of the compounds under a biological matrix. As the small molecular drug moves through different stages of the drug development process, the drug requires various clinical and preclinical studies for its evaluation within the biological matrix, either a serum or a plasma. Just as observed for the large biomolecules, the small molecule bioanalysis also involves the pharmacokinetic, toxicokinetic, and biomarker assays.