Preclinical testing plays a vital role in the drug development process by evaluating potential new drug candidates for safety and efficacy before human clinical trials. This testing involves in vivo studies using animal models to study a drug's pharmacokinetics, toxicity, and ability to achieve the desired therapeutic effect. In vivo contract research organizations (CROs) perform the majority of these preclinical studies on behalf of pharmaceutical and biotech sponsors. They offer labs, specialized technical expertise, and regulatory knowledge to help move potential new therapies efficiently through the necessary preclinical stages.
In vivo CROs handle all aspects of preclinical drug testing, from study design and protocol development to conducting the studies, analyzing results, and generating final reports. Their goal is to help clients evaluate compounds and advance the most promising candidates into human clinical trials safely and expeditiously. Proper preclinical evaluation is essential, as it helps rule out compounds with unacceptable toxicity profiles early in development and identifies the appropriate dosing levels and routes of administration to use in initial human trials.
Rodent and Non-Rodent Species Testing
Rats and mice are the most frequently used animal models in preclinical studies due to their similarities to human physiology and widespread commercial availability of various strains. In Vivo CRO house large colonies of these rodents to provide the numbers needed for statistically powered preclinical trials. Common study types involving rats and mice include safety pharmacology, pharmacokinetics, toxicology, efficacy and disease model evaluations.
However, preclinical testing frequently incorporates other species as well to address specific scientific questions or drug targets. For example, non-human primates or dogs are commonly used where the drug target is uniquely found in larger species. Ferrets, rabbits, guinea pigs, and hamsters are also utilized depending on the study context. In vivo CROs have extensive experience carrying out GLP-compliant preclinical research across a wide array of animal models. Their centralized animal care facilities and technical staff allow for testing across multiple animal species under one roof.
Adherence to Regulatory Standards
Compliance with Good Laboratory Practice (GLP) standards is critically important for preclinical studies intended to support future regulatory filings. GLP regulations ensure preclinical data quality through standardized operating procedures, dedicated facilities, extensive record-keeping, and quality control measures. In vivo CROs are rigorously GLP-certified by regulatory bodies like the FDA. Their labs undergo frequent quality audits, and all studies are conducted according to GLP regulations for design, conduct, monitoring, recording, reporting and archiving. This provides clients with preclinical packages well-positioned for regulatory agency acceptance as the data quality stands up to scrutiny.
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