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Drug discovery is the process that is intended to identify a small molecule or a large biomolecule for comprehensive evaluation as a potential drug candidate. Broadly speaking, the modern drug discovery process can be divided into preclinical and clinical development stages. In preclinical development, toxicological and safety pharmacology studies of the candidate are performed to establish the maximum safe concentrations in animals and determine the adverse effect potential of the drug-in-development. Creative Biolabs has established excellent platforms for drug development. We provide professional preclinical development services to meet the diverse needs of our customers.
The preclinical development process includes a selection of the drug-like molecular targets and their validation, in vitro assay development followed by high throughput screening of compound libraries against the targets to identify hits, and hit optimization to generate lead compounds that exhibit adequate potency and selectivity towards the biological target in vitro and which demonstrates efficacy in animal models of disease. Subsequently, the lead compounds are further optimized to improve their efficacy and pharmacokinetics before they advance towards drug development.
Fig.1 Preclinical development process from target verification to candidate identification.
Preclinical development is an essential stage of early drug development performed before clinical trials. This critical phase encompasses all the tasks required to advance a new drug candidate through manufacturing, formulation, pharmacology, pharmacokinetics and toxicology testing. Creative Biolabs provides the following services for preclinical development:
Target identification and validation begins with the identification of the function of a possible therapeutic target and its role in the disease. The identification of the target is followed by the characterization of the molecular mechanisms addressed by the target. A good target should be effective, safe, meet clinical and commercial requirements and be 'druggable'.
Once identified, the target then needs to be fully validated. Validation techniques range from in vitro tools through the use of whole animal models, to modulation of the desired target in disease patients. While each approach is valid in its own right, confidence in the observed outcome is significantly increased by a multi-validation approach.
The goal of lead validation is to generate preclinical development candidates by improving the shortcomings of the lead structure by chemical modifications. Generally, the aim is to enhance the physicochemical and ADME properties and minimize the toxicity so that a potentially safe compound with favorable pharmacokinetics is identified.
Once a drug candidate is shown to be effective in animals and to have a low incidence of side effects, safety assessment testing will be performed. These tests are conducted to evaluate drug safety in different animal species, with animals receiving high doses of the new drug for 30 or 90 days. The drug safety testing in animals is carried out in accordance with the legal regulation.
Pharmacokinetics (PK) describes what the human body does to a given pharmaceutical, from the time of administration to absorption, distribution, metabolism, and excretion from the body. Pharmacodynamics (PD) studies the biochemical, physiologic, and molecular effects of drugs on the body. Together PK/PD data explain the dose-response relationship of a drug and are integral in designing the dose, route, and schedule of administration to maximize effectiveness while reducing adverse effects.
Creative Biolabs provides high-quality preclinical development services for risk-based preclinical data verification. With our stringent quality control, you can trust our scientists to help lead and support your drug development programs through each phase of the preclinical process. If you are interested in our services, please contact us for more details.