CD Formulation is a global pharmaceutical company, and we have completed thousands of animal model preparation over the years, covering the digestive system, respiratory system, cardiovascular system, nervous system, tumor animal models to prepare more than 100 kinds of mature animal disease models. A complete set of pathology, histology, behavioral and other detection methods.
In the process of drug development, drug effectiveness evaluation is one of the keys to determine whether a drug can be marketed. Drug effectiveness studies include pharmacodynamics studies in preclinical animal trials and effectiveness studies in human clinical trials. Pharmacodynamic animal tests should be combined with the actual clinical diseases and treatment, reasonable selection of test models and methods, and design according to the classification of drugs and the characteristics of pharmacological action. For liposome drug development, animal pharmacodynamic tests are the basis of human clinical trials.
Our services for liposome drug efficacy evaluation are as following.
According to the mechanism of drug action, animal disease models with corresponding pathogenesis should be selected. If the mechanism of drug action is unclear, multiple models and methods should be used as far as possible to reflect and confirm the effectiveness of each other, and the experimental model should reflect the essence of clinical efficacy as far as possible.
Fig.1 Our workflow for liposome drug efficacy evaluation. (CD Formulation)
Platforms | Specifics |
Metabolic Disease Evaluation Platform |
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Evaluation of Immune System DiseasesPlatform |
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Nervous System Evaluation Platform |
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Nervous System Evaluation Platform |
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Ophthalmic Drug Evaluation platform |
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Technology: culture-based microtitration method in liposomal formulation of amphotericin B
Journal: Indian J Med Res
IF: 4.2
Published: 2013
Results: In this study, the author evaluated the in vivo anti-leishmanial efficacy and related side effects of Kalsome™10 in BALB/c mice. The traditional method for detecting and quantifying the parasite burden in different mouse tissues and evaluating the anti-leishmanial efficacy of the drug, which involves microscopic counting of the amastigote forms in the host cell nucleus, is still used. This method is time-consuming and subjective, and may not be reliable if the parasites are not evenly distributed on the slide. Therefore, a culture-based microtitration method was developed. This method is more sensitive than the smear method, but labor-intensive and time-consuming. Other limitations include the very low number of parasites. Since the recurrence of leishmaniosis is related to the tissue burden of residual and dormant parasites after treatment, quantitative PCR (qPCR) detection is not useful for indicating positive or negative results. Therefore, in this study, the efficacy of the novel anti-leishmanial agent was evaluated by quantitative real-time PCR (qRT-PCR) using primers targeting the conserved region of the internal transcribed spacer (ITS) of the DNA of the Duonowanilishmanial nDNA as evidence of its anti-leishmanial activity.
Fig.2 Flowchart summarizing the experimental details of the study. (Mishra J, et al., 2013)
CD Formulation has accumulated many years of project experience in the study of the drug efficacy evaluation, and our team of scientists and experts are ready to answer your questions and provide advice. If you need our help, please contact us at your convenience.
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