Preclinical Development Service

Preclinical Development Service

In drug development, preclinical development, also termed preclinical studies or nonclinical studies, is a stage of research that begins before clinical trials (testing in humans). Typically, both in vitro and in vivo studies are performed, and these studies must provide detailed information required for further development. Ace Metabolism can provide the services related to preclinical development for diabetes drugs.

Overview of Preclinical Research

For preclinical development, an appropriate animal model that accurately reflects human pathological conditions is essential. Cell and molecular studies provide important mechanistic data and toxicity studies evaluate candidate drugs. Drugs may undergo pharmacology and toxicology testing. Pharmacology emphasizes the therapeutic effects of chemicals, whereas toxicology is the study of chemical's adverse effects and risk assessment.

  • Stem Cell Therapies Preclinical Studies
    The clinical translation of stem cell therapies requires preclinical experimentation to assess their feasibility, safety, and efficacy. Stem cells from more recently discovered sources, require activity and safety assessment in relevant animal models. Careful attention must be paid to the survival, migration, phenotype, function, and potential toxicities of the implanted cells.
  • Gene Therapies Preclinical Studies
    Gene therapy toxicology and safety pharmacology studies must be conducted to advance new therapies to human clinical trials. And unlike other therapy classes such as small molecules or biologics, gene therapy preclinical study requirements are individually tailored to the characteristics of the therapy.
  • Small Molecules Drug Preclinical Studies
    Drugs may undergo pharmacology and toxicology testing. Pharmacology is closely related to toxicology, which including pharmacodynamics (PD) and pharmacokinetics (PK). Both pharmacology and toxicology are scientific disciplines that focus on understanding the properties and actions of chemicals.
  • Fig 2. Biofilm Lifestyle and PharmacodynamicsBiofilm Lifestyle and Pharmacodynamics (Trubenov√°, B.; et al. Trends in Microbiology, 2022)

  • Antibody Therapies Preclinical Studies
    Antibody-drug conjugates, bispecific antibodies and other novel antibodies have the advantages of high specificity, strong selectivity and non-cytotoxicity. However, the structure and function of such drugs are relatively complex, which brings special risks to safety. In the preclinical safety evaluation, it is necessary to establish a scientific evaluation scheme according to its characteristics and possible mediated toxicity mechanisms.

Our Services

Ace Metabolism supports the evaluation of therapeutics of multiple forms, including stem cell therapy, gene therapy, small molecules, antibodies. As your single source provider of comprehensive preclinical services, we develop custom-tailored plans to meet all your needs. Our services include but not limited to the followings.

Stem Cell Therapy Preclinical Studies

Stem Cell Therapy Preclinical Studies

  • Establishing effective stem cell labeling technology and animal in vivo stem cell tracking technology
  • Animal pharmacology and toxicology studies

Gene Therapy Preclinical Studies

Gene Therapy Preclinical Studies

  • Efficacy or gene expression studies
  • Biodistribution studies (quantitation in blood and/or tissues)
  • Animal pharmacology and toxicology studies

Small Molecules Drug Preclinical Studies

Small Molecules Drug Preclinical Studies

  • Assessing the pharmacology of a drug (PK, PD, ADME)
  • Toxicity evaluation in vivo, in vitro and in silico

Antibody Therapies Preclinical Studies

Antibody Therapies Preclinical Studies

  • In vivo efficacy study and ex vivo study
  • PK/PD and exploratory toxicology
  • Tissue cross reactivity and hemolysis test

Features of Our Services

Highly CustomizableHighly Customizable

One-stop ServicesOne-stop Services

High QualitysHigh Quality

Professional TeamProfessional Team

Ace Metabolism can accelerate the therapeutic development and drug discovery process about diabetes for our clients worldwide. Our assays are developed and processed with the highest standard and the results are delivered on time without compromising quality. Please feel free to contact us.

References

  1. Trubenov√°, B.; et al. Population genetics, biofilm recalcitrance, and antibiotic resistance evolution. Trends in Microbiology, 2022.
  2. Premarathna, A. D.; et al. Preliminary screening of the aqueous extracts of twenty-three different seaweed species in Sri Lanka with in-vitro and in-vivo assays. Heliyon, 2020, 6(6), e03918.
All of our services and products are intended for preclinical research use only and cannot be used to diagnose, treat or manage patients.
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