Safety Evaluation Services for Antiparasitic Drugs
Toxicology is the study of the possible harmful effects of drugs on the body under certain conditions and their mechanisms, and is an important element of drug development, necessary for the first clinical study of new drugs, and is important for clinical risk identification and control. In recent years, the scope of anti-parasitic drug toxicology studies is also undergoing great changes, highlighting the importance of translational toxicology studies to facilitate early decision-making in drug development, shorten the development time of new drugs and reduce costs.
Based on the internationally accredited AAALAC quality standards and a quality management system for drug safety evaluation in accordance with international GLP regulations, Ace Therapeutics provides high-quality safety evaluation services for GLP of antiparasitic drugs, covering multiple toxicity systems, and has internationally recognized pathology studies to support our safety evaluation studies.
Safety Evaluation Service Options for Antiparasitic Drugs
| Pharmacological and toxicological studies |
- Single-dose toxicity tests
- Repeated administration toxicity test
- Genotoxicity test
- Immunogenicity test
- Toxicokinetics
- Local toxicity tests
- Toxicological tests for new drug delivery technologies
- ADC safety evaluation
- Safety pharmacological tests
- Reproductive toxicity test
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| Safety pharmacology |
- Core combination test — spontaneous activity, functional observation combination (FOB), whole body volume tracing, telemetry
- hERG experiments
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| Histopathology studies |
- HE staining
- Special staining.
- Immunohistochemistry (HC)
- Tissue cross-reactivity (TCR)
- Paraffin sectioning, frozen sectioning, special staining, etc.
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| Toxicokinetics |
In vitro ADME studies
- Metabolic stability (hepatic microsomes, S9, Cytosol, hepatocytes, blood)
- Metabolite identification
- Plasma protein binding assay
- CYPase inhibition studies (DDI and TDI)
- CYPase induction studies
- Transporter substrate and inhibition evaluation
- Enzyme phenotype analysis
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In vivo PK study
- Solute and formulation screening
- Bridging experiments between preclinical and clinical formulations
- Bioavailability
- Tissue distribution
- Biliary, urinary and fecal excretion
- BE studies
- PK/PD studies
- Metabolite identification of in vivo samples
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In vivo TK study
- TK/PD/TOX analysis
- Sex difference/dose correlation/accumulation analysis
- Active ingredient/prodrug/metabolite monitoring
- Metabolite identification of TK samples
- Immunogenicity analysis
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Quotation and Ordering
In order to provide an efficient and accurate quote, please complete the online inquiry form and send it to us, we will reply to you the first time. Feel free to consult us for more details about our services.
Our Advantages
- Ace Therapeutics keeps up with the development of the industry and market demand, and constantly improves and innovates. After years of experience, multiple validations, and long-term practical tests, we have established a complete library of animal models of parasitic organisms and can provide various effective animal models for testing the effectiveness of drugs according to customers' needs. The experimental animals include non-human primates, dogs, rats and mice, rabbits, guinea pigs, and small pigs.
- We are a one-stop shop for anti-parasitic new drug projects. Our full process of experimental design, protocol implementation, result interpretation, report compilation, and data writing helps our clients to obtain IND approval in one go.
All of our services and products are intended for preclinical research use only and cannot be used to diagnose, treat or manage patients.
