In Vivo PD

Empowered by procedures and execution of high-quality in vivo animal study from data acquisition to analyses, Creative Biolabs ensures you in compliance with international regulatory guidance, such as FDA, EMA, CFDA and ICH. We offer an array of pre-clinical pharmacodynamics (PD) services of pharmacological effects including a wide range of biomarkers for accurate decision making.

In Vivo Pharmacodynamics Service

Following the PK studies, the discovery program typically ensures the investigation of pharmacodynamic (PD) biomarkers in multiple species. Creative Biolabs routinely performs in vivo PD studies that generate various PD endpoints.

Our in vivo PD services can seamlessly perform in vivo sample generation as well as endpoints readout to determine what does the candidate do to the animal models. Creative Biolabs can conduct PD studies in most rodent species. Thoroughly understanding the PD profile of a potential clinical candidate has a huge determinant impact on the success of a drug discovery program.

Carrying out PD studies will provide the following information:

• Relationship between the concentration of a candidate in the animal models and its biological effects (dose responses);
• Addressing potentialities and effectiveness of the candidate with regard to its desired pharmacological effects;
• Determine the therapeutic index of a drug (describing the ratio of the dose causing toxicity to the dose that elicits a therapeutic effect);
• Therapeutic window (large therapeutic index indicates a wide therapeutic window).

We offer study design, implementation for seamless access to analysis including:

• PD modeling & simulation;
• Our clinical team is experienced in pharmacodynamic assessments in different cancer immunotherapeutic areas. Our modeling and simulation team collaborates with clients to develop innovative pharmacodynamic models.
• Study design input;
• PD analysis and reporting of PD outcomes;
• Written interpretation of PD results for ICH study reports.

Various PD endpoints for measurement including:

• Short lead time for study initiation;
• Timed dosing by various routes (PO, IV, IP, IM, SC, ICV, IN, IT, etc.);
• Single agents, cassette dosing, repeat doses;
• Radiolabeled compound capabilities;
• Multiple sample time points over extended periods;
• Rodents – blood, urine, bile, CSF, tissue;
• Histology and pathology expertise;
• Nonrodents;
• Formulation services;
• In-house pharmacy with extensive experience and a wide range of standard vehicle components;
• Bioanalytical support.

Our pre-clinical PD services aim to offer safety and efficacy profiles of drug and therapeutic candidates prior to testing them in humans. Creative Biolabs provides customized PD studies to identify the evidence for the biological effects of candidates in compliance with GLP guidelines to ensure reliable results and facilitate IND approval. It’s a viable business option to outsource your PD studies to us. Please don’t hesitate to contact us for more detailed information.

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