Bioanalysis is the quantitative evaluation of a chemical (drug) or its metabolite in biological fluids, most commonly blood, plasma, serum, urine, or tissue extracts.
Bioanalytical CRO- Pharmaceutical and biotechnology businesses, academic institutions, and government agencies use bioanalytical Contract Research Organizations (CROs) to conduct research.
Drug discovery vs. drug development
There are numerous stages and actions involved in the drug discovery process. We can usually break it down into four stages:
1) Drug Discovery at an Early Stage
2) The Preclinical Stage
3)Phases of Clinical Trials and Regulatory Approval
Drug development aims to find a therapeutically beneficial chemical for curing and treating disease. Identification of candidates, synthesis, characterization, validation, optimization, screening and tests for therapeutic efficacy are all part of this process. Once a chemical has been proven helpful in these studies, it will begin the drug development process before clinical trials. The new drug development process must go through numerous
drug discovery and development steps:
1)Identification of Target
2) Target validation
3) Lead identification
4) Lead optimization
5) Characterisation of product
6) Conceptualization and creation
7) Preclinical research
8) New Drug Investigation
10) Drug Approval Request
1) Identification of the intended audience. The identification of the biological origins of a disease, as well as prospective intervention targets, is the first stage in drug discovery. Isolating the function of a potential therapeutic target (gene/nucleic acid/protein) and its significance in the disease is the first step in target discovery. Following the identification of the target, the molecular mechanisms addressed by the target are characterized.
2) Validation of the Goal -The process of certifying the intended molecular target – such as a gene, protein, or nucleic acid of a tiny chemical – is known as target validation.
3) A synthetically stable, viable, and drug-like molecule active in primary and secondary assays with adequate specificity, affinity, and selectivity for the target receptor is classified as a chemical lead.
4) Optimization of Leads – After identifying an initial lead molecule, the process of lead optimization is used to build a drug candidate. The method entails an iterative series of synthesis and characterization of a potential medicine to construct a representation of how chemical structure and activity are related in terms of interactions with targets and metabolism.
5) Characterization of Product – When a new medicinal molecule exhibits promising therapeutic efficacy, its size, shape, strength, weakness, usage, toxicity, and biological activity are evaluated. Pharmacological research in the early phases can assist in characterizing the compound’s mechanism of action.
6) Pharmaceutical formulation is the stage of medication development when the physicochemical properties of active pharmaceutical ingredients (APIs) are studied to create a bioavailable, stable, and appropriate dosage form for a given delivery route. It should be performed in the best bioanalytical lab.
7) Preclinical testing is a step in drug development that involves evaluating a medicine’s safety and efficacy in animal models before moving on to a potential human result. The appropriate regulatory authorities must also approve the preclinical experiments. The regulatory authorities must ensure that studies are conducted safely and ethically, and only those drugs that have been proven safe and effective will be approved.
8) Clinical Trials – Clinical trials are studies undertaken on individuals (volunteers) to answer specific questions about the safety and efficacy of medications, vaccines, other therapies, or novel ways of using existing treatments.