Preclinical CRO is a support center offering expertise in research and development necessary for navigating a drug candidate through animal testing and advancing it into the clinical phase. Preclinical research services involve several studies critical to asses drug efficacy and safety in animal models and complete Investigational New Drug (IND) filing studies. Successful completion of the drug IND package is the first milestone towards clinical development.
Many drugs are rejected during the preclinical stage due to subpar treatment effects or adverse outcomes including toxicity. If these studies are not appropriately designed, your medication can be dismissed by the regulatory authorities in error. Hence, it is imperative to look for a preclinical CRO with competent personnel who have relevant scientific expertise as well as regulatory awareness.
Before a drug could be released in the market, a set of studies are conducted to predict its safety and efficacy in humans. These clinical studies are often conducted following intensive animal studies under the supervision of pharmaceutical scientists and experts. This animal testing must follow the ethics and regulations set for animal use in preclinical research. First in man study is designed based on the preclinical studies including first safe dose in phase I study.
Preclinical research in drug development is a risk-assessment process to know the impact of a drug on animals and extrapolate the possible outcome in humans. The preclinical studies, such as the toxicological and pharmacologic responses of the drug in relevance to the dose, assist in advancing the research with human volunteers.
For regulatory compliance with continuing the drug study, the sample collection and testing environment must be up to the specified standards of facility upkeep, treatment ethics, and safe dosage. The right preclinical CRO meets or exceeds these expectations to support an accelerated clearing of this initial stage of drug development. Furthermore, the insights gained from the preclinical testing help with a streamlined drug development moving onwards.
Pharmacology testing helps assess the pharmacodynamic and pharmacokinetic properties exhibited by a drug. Both these properties are essential as they help measure and identify the desirable and undesirable outcomes of the drug in the animal models. Pharmacokinetic properties help in defining ADME (adsorption, distribution, metabolism, and excretion) properties of a drug compound which provides a scientific understanding of the drug for making appropriate decisions and designing further experiments, studies, and trials as next steps.
The toxicological activity of the drug product is measured through in vitro and in vivo studies. While in vitro gives direct impact on cell proliferation and phenotype, in vivo studies evaluate the toxicity profile of a drug by identifying its effects on different animal species.
Throughout the preclinical testing phase, one crucial factor is the selection of relevant animal species and models. Knowing the impact of pharmacological and toxicological studies in the correct animal species and models creates the basis for clinical trials.
Preclinical research services offered by NorthEast BioLab include the bioanalysis of drug candidates during in-vitro and in-vivo studies. These bioanalytical studies require analysis of drug and metabolites in various biological fluids and tissues from different organs. Several of these analytical tests earlier in drug discovery and development can be completed using non-validated bioanalytical methods. Once the in-vitro studies are completed, in-vivo studies are initiated, e.g., bioavailability studies followed by dose range finding studies. As the drug candidate progress into GLP Toxicity studies in various animal species, a fully validated method is required for the analysis of drug and metabolites.
The method development, validation, and transfer are processes used to set-up and confirm whether the bioanalytical procedure for drug analysis is suitable for its intended use. Adequate methods during the preclinical stage are essential for a straightforward transition of sample analysis from animal species to the clinical phase.
The bioanalysis study in drug development measures drug and metabolites in biological fluids such as plasma, blood, serum, urine, etc. LC MS MS is mostly used for the analysis as it has been established to provide significantly more reliable and reproducible results.
NorthEast BioLab offers various client-centric preclinical and clinical ELISA assay development services. We help you select the right ELISA assay and further optimize assay development and validation to ensure accurate and robust results.
It is essential to evaluate the stability of the drug candidate in blood, plasma, and any other biological fluids where the drug is being measured. Incorrect results would be generated if the drug is unstable in the examined matrix, and that can affect drug development at a later stage and lead to failure. There are many available techniques to stabilize the drug and measure it accurately. At Northeast BioLab, we have worked on several such drugs and successfully stabilized and quantitated them during preclinical and clinical studies.
Adopting a pragmatic approach in preclinical research, NorthEast Biolab mitigates the risks of your drug development program. With a team of experienced, skilled professionals, we help the sponsors fulfill research needs and reduce the time to reach the clinical phase. Our preclinical research services include preclinical testing such as biomarker testing, bioanalysis, as well as method development, validation, and transfer, etc.
Access to expert resources and 15+ years of experience enables us to provide an excellent in vitro, in vivo, and bioanalytical testing services to our clients. Regardless of the phase in which your drug product is currently, NorthEast Biolab can help you navigate various testing requirements and regulatory hurdles. Introducing life-changing drug products to the market has the power of enhancing the lives of innumerable patients, and we are here to help make your drugs reach the markets as quickly as possible.