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Pharmacodynamic (PD) Assays for Nucleic Acid Drugs

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Pharmacodynamics is becoming increasingly valuable in assessing drug activity and target modulation in clinical trials. CD Formulation integrates state-of-the-art technology with industry-leading PD expertise to provide comprehensive PD analytical testing. Our scientific team has the necessary expertise and capabilities to provide a total solution for PD analysis, with a focus on innovative research.

Why Pharmacodynamics Assays for Nucleic Acids?

Pharmacodynamics (PD) is the study of the biochemical, physiological and molecular effects of nucleic acid drugs on the human body, involving receptor binding, post-receptor effects and chemical interactions. It is a study of how a drug affects an organism. In order to better evaluate and optimize nucleic acid drugs, it is necessary to carry out in-depth PD analysis studies to comprehensively analyze the dynamic process of the drug in the body by detecting changes in its concentration in the target organ or target cell, as well as changes in the relevant pharmacological indicators. Only in this way can we provide a more accurate and reliable basis for the optimization of clinical drug regimen.

Fig.1 MIDO is a drug development method based on PK and PD. Fig.1 MIDO is a PK/PD method that can be used to identify information-rich markers. (Luterbach C L, et al., 2022)

Explore Our Nucleic Acid Pharmacodynamic Assays Services

Pharmacodynamic studies determine how drugs and substances affect biological systems in organisms, understand how drugs modulate target receptors and cellular pathways, and analyze the biological processes they undergo. CD Formulation's core team of pharmacologists is experienced in conducting in vivo PK studies, and our PD studies allow us to provide valuable insights into the behavioral or psychological effects of drugs in organisms. PD studies allow us to provide valuable insights into the behavioral or psychological effects of drugs in organisms, while seamlessly integrating multiple assays to meet your specific requirements and needs.

In vivo pharmacodynamics studies will provide insights into the mechanism of action, potency and efficacy of a drug, as well as a wide range of other support for drug development, including the following service offerings.

Items Descriptions
Dose-response Relationship Analysis Analyzing the effects of different doses of a substance based on the desired pharmacological response, evaluating the optimal dose range and thus determining whether the drug achieves the desired therapeutic outcome.
Effective Dose Range Testing PD studies will help determine the therapeutic range of the drug or substance, which will help optimize the dosing regimen and reduce the risk of adverse effects.
Substance-Substance Interaction Testing Evaluates the pharmacodynamic interactions between the target drug and other substances, develops drug combination strategies, predicts potential adverse reactions, and optimizes therapeutic regimens.
Predictive Modeling Develop predictive models that simulate the effects of a drug under different scenarios to help predict drug responses, optimize dosing strategies, and provide decision-making information throughout the development process and clinical trial design.

Our Advanced Pharmacodynamic Assays Platform for Nucleic Acids

We are experts in developing and validating assays to assess PD behavior at all stages of the drug development process using the following platforms.

  • ELISA
  • MSD-ECL
  • Gyrolab
  • Protein Simple Ella
  • Flow Cytometry
  • qPCR
  • ddPCR
  • LC-MS/MS
  • HPLC
  • LI-COR

Our Workflow for Nucleic Acid Drugs Pharmacokinetic Assays

Fig.2 Workflow of nucleic acid PD analysis.Fig.2 Flow chart of nucleic acid drugs pharmacokinetic assays. (CD Formulation)

Experimental Design

Craft a comprehensive experimental protocol tailored to the study's objectives. This includes the careful selection of suitable cell models and relevant biomarkers to ensure precise and meaningful results.

Sample Processing

Obtain cell or tissue samples at designated time points. Apply necessary pre-treatment processes to prepare the samples adequately for further analysis.

Detection & Analysis

Employ a variety of biochemical, immunological, or molecular biological methods to accurately measure and analyze the expression levels or activities of key biomarkers.

Reporting of Results

Utilize multiple biochemical, immunological, and molecular biological techniques to assess and report the expression levels or activities of the relevant biomarkers.

Why Choose Us for Nucleic Acid Drugs Pharmacodynamic Assays?

  • Our scientific team has extensive expertise in a range of assays, including the measurement of soluble biomarkers and molecular events, to ensure reliable and reproducible results.
  • We have successfully developed, optimized and validated our PD assay services for a variety of regulatory conditions.
  • Our services are fully compliant with clinical and laboratory standards for determining minimum inhibitory concentration (MIC), antimicrobial drug dosing intervals, drug combinations, and antimicrobial drug concentrations in relation to microbial growth rates.

Publication Data

Technology: Analysis of drugs utilizing Pharmacodynamic Assays

Journal: Clinical Pharmacology and Therapeutics

IF: 6.3

Published: 2020

Results:

To ensure that U.S. patients receive the public health benefits of a robust competitive market for biosimilars, the U.S. Food and Drug Administration (FDA) is working to improve the efficiency of biosimilar development and approval. Because comparative clinical studies are both costly and time-consuming, the FDA is currently conducting research to streamline or eliminate the need for comparative clinical studies by providing the agency with ideas on key aspects of using pharmacodynamic (PD) biomarkers to demonstrate biosimilarity.

Fig.3 Pharmacodynamic assays for drugsFig.3 PD (pharmacodynamic) biomarker for biosimilars. (Li J, et al., 2020)

Based on our extensive experience, CD Formulation can support your nucleic acid formulation development program from start to finish, with fast cycle times and the latest innovations. We can design appropriate pharmacokinetic studies and complete pharmacokinetic calculations. Our high quality PD analysis services will greatly contribute to the success of your project. Please feel free to contact us for more information and a detailed quote.

References

  1. Luterbach C L, Rao G G. Use of pharmacokinetic/pharmacodynamic approaches for dose optimization: A case study of plazomicin. Curr. Opin. Microbiol. 2022, 70: 102204.
  2. Li J, Florian J, Campbell E, et al. Advancing biosimilar development using pharmacodynamic biomarkers in clinical pharmacology studies. CLIN PHARMACOL THER. 2020, 107(1): 40.
How It Works
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STEP 3
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At CD Formulation, we understand the unique challenges and opportunities associated with nucleic acid formulation development. Our team of experts is dedicated to providing tailored solutions...

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