Understanding the pharmacodynamics of a given therapeutic protein/peptide can help determine the action and effect of the drug on the target biomolecule or target, including the potency, efficacy, and toxicity of the drug. CD Formulation provides clients with a full range of pharmacodynamic (PD) studies to understand the interaction of therapeutic proteins and peptides with the human body. Our team has extensive experience and expertise, providing clients with customized pharmacodynamic study programs and reliable data and results through rigorous experimental design and analysis methods.

The Importance of PD Studies for Proteins and Peptides

Pharmacodynamics (PD) is the study of the biochemical, physiological, and molecular effects of drugs on the human body, involving receptor binding (including receptor sensitivity), post-receptor effects, and chemical interactions. Together with pharmacokinetics (PK), PD helps explain the relationship between dose and response, i.e., the effects of a drug. In addition, PD studies can:

• Elucidate the mechanism of action: One of the key aspects of PD studies of proteins and peptides is to determine their mechanism of action, which includes understanding how these molecules bind to their target receptors, activate signaling pathways, and regulate cellular functions. By elucidating the specific interactions between proteins/peptides and their target receptors, researchers can design more effective and targeted treatments.
• Optimize dosing regimens: PD studies help optimize the dosing regimens of proteins and peptides. These molecules often have complex PK characteristics due to their large size and susceptibility to degradation in the body. By studying their PD properties, researchers can determine the most effective dosing regimen to achieve the desired therapeutic effect while minimizing side effects and toxicity.
• Ensure patient safety: PD studies provide insights into the safety of proteins and peptides. By studying their effects on various physiological systems and tissues, researchers can assess the risk of adverse reactions and potential long-term consequences of treatment. This information is critical to ensuring the safety of patients receiving protein and peptide therapies.
• Comply with regulatory requirements: PD data provides essential information for drug registration and regulation to ensure the quality and compliance of drugs.

Fig. 1 The Importance of pharmacodynamic (PD) studies for proteins and peptides. (CD Formulation)

Explore Our Proteins & Peptides In Vivo PD Studies

Regulatory agencies require that any protein and peptide therapeutic agent entering clinical trials or marketing applications must provide data on the drug's pharmacological properties, pharmacokinetics, pharmacodynamics, and safety. At CD Formulation, our experienced protein and peptide experts will work closely with you to gain a deep understanding of the key data for your therapeutic protein/peptide PD study and help you design and execute the appropriate experiments to ensure regulatory compliance.

CD Formulation has extensive experience in conducting pharmacodynamic studies, especially for therapeutic protein and peptide biologics. Our PD study team can help design customized early pharmacodynamic studies and answer all of your specific scientific questions. We provide the following services to evaluate the PD behavior of your therapeutic protein/peptide drug development process at all stages.

• Protein and peptide PD studies analytical method development.
• Optimization of PD study analytical methods for existing proteins and peptides.
• Validation of PD study analytical methods for accuracy, precision, linear range, specificity, robustness, and LOD/LOQ according to ICH drug requirements.
• Support for regulatory submission of PD data.
• Transfer of analytical methods for PK testing of proteins and peptides.
• Support for batch-release testing.
• Mechanism of action studies.

Our Administration Pathways and Acquisition for Protein/Peptide

The design of a PD study depends primarily on the mode of action and whether surrogate markers can be identified and quantified. In our analytical laboratories, protein/peptide biologics PD study is often performed in parallel with pharmacokinetic (PK) assessments.

Our research team considers factors such as route of administration, collection method, drug concentration, amount of injected drug, temperature, and modeling to help evaluate the distribution of your protein/peptide therapeutic in animals over time.

Available Administration Pathways

• Administration by Injection or Infusion
• Inhalational Administration
• Intranasal Administration
• Transdermal Administration
• Peroral Administration

Available Sample Collections:

• Blood collection.
• Tear/aqueous humor collection.
• Urine and cerebrospinal fluid collection.
• Organ (heart, liver, spleen, lung, kidney) collection.
• Tissue (skin, muscle, etc.) collection.
• Cell (blood cells, white blood cells, tumor cells, etc.) collection.

What Research Subjects Do We Work With?

The right animal model is a critical factor in the smooth and successful implementation of PK/PD studies. Our comprehensive portfolio of disease states and surgical models provides our global clients with the powerful tools they need to accurately evaluate the effects of protein/peptide therapeutics on physiological systems. By employing these sophisticated methods, we can replicate conditions that closely resemble the clinical setting, thereby increasing the reliability and validity of our findings.

Available species include:

• Mice/rats.
• guinea pigs.
• Rabbits.
• Canines.
• Pigs/minipigs.
• Non-human primates (NHPs).

Our Technology Platforms

Why Choose Us for Proteins & Peptides In Vivo PD Studies?

• We have a team of experts with rich experience in developing PD analysis methods for protein/peptide biologics.
• We are familiar with the industry practices and regulatory requirements for developing and validating acceptable PD analysis methods for protein/peptide biologics.
• We support model customization and PD analysis services for multiple species (including rodents, humans, and non-human primates).
• We provide high-quality PD studies and results that strictly comply with GLP and GCP regulations and international regulatory standards (FDA, EMEA, ICH).
• We perform dozens of protein and peptide biopharmaceutical PD Studies projects every year.
• We offer flexible experimental designs and customized solutions.

Publication

CD Formulation has extensive expertise in analytical method development and PD studies of therapeutic proteins and peptides. We can perform PK/PD studies to assess the efficacy and safety of your protein or peptide drug candidate to help you achieve success in bringing your therapeutic protein or peptide to market as quickly and efficiently as possible. please contact us today to learn more about how we can support your PK/PD study needs.