Oral Thin Film Pharmacokinetic and Pharmacodynamic Evaluation
Inquiry
Oral thin film pharmacokinetic (PK) evaluations aim to understand the absorption, distribution, metabolism, and excretion of drugs in the body, providing a crucial basis for the safety and dosage of oral thin films. Oral thin film pharmacodynamic (PD) evaluations explore the interaction between drugs and their targets, as well as the therapeutic effects on specific diseases. CD Formulation's PK and PD service departments are led by senior professionals with solid theoretical knowledge and extensive experimental experience. They oversee experimental design, implementation, biological analysis, and data analysis.
Fig.1 The plasma concentration–time curve wit in 48 h(A) and 6 h(B). (Zhiyuan Zhang, et al., 2018)
The Importance of Oral Thin Film PK and PD Evaluation
- Characterize oral thin film drug exposure
- Determine an appropriate dose for a clinical study
- Assess changes in dose requirements
- Estimate the rate of elimination and absorption
- Assess the relative bioavailability/bioequivalence of oral thin films
- Understand concentration-effect relationships
- Establish safety margins and efficacy characteristics of oral thin film
Our Oral Thin Film PK and PD Evaluation Services
CD Formulation can design and carry out in vivo and in vitro PK tests and PD studies of oral thin films according to customer needs and provide a complete set of PK and PD evaluation and optimization services. Our high-efficiency experimental cycle can satisfy customers from early oral thin film drug discovery to filing requirements. Our oral thin film PK and PD evaluation services include, but are not limited to:
- Evaluation design: Including sample size estimation and PK sampling optimization
- Non-compartmental PK modeling
- Fast turnaround interim PK analyses in support of first time-in-man studies
- Compartmental PK modeling
- Statistical analysis: Including bioequivalence, bioavailability, food effects, drug-drug interactions, dose ratios, and special populations
- PK handover document production
- PD analyses: Using various graphical and statistical approaches
- PK/PD linear and non-linear mixed modeling techniques
- Simulation to help predict systemic exposure (and PD effects) for alternative dosing regimens
Our Platforms for Oral Thin Film PK and PD Evaluation
| Technologies & Platforms |
Description |
| Evaluation Design Platform |
Our evaluation design includes oral thin film sample size estimation, PK sampling optimization, non-compartmental PK modeling, and compartmental PK model building, among other services. |
| PK Study Platform |
Our PK experimental studies follow the guiding principles of ICH and FDA, and we can design and carry out in vivo and in vitro PK studies according to customer needs, providing a complete set of PK evaluation and optimization services. |
| PD Study Platform |
The main experimental contents of our PD study include in vitro tests (biochemical tests, cell tests, etc.) and in vivo tests (whole animal tests). In in vivo PD studies, we focus on the selection of appropriate animal models. |
Advantages of Our Oral Thin Film PK and PD Evaluation
- Full Service: We provide a comprehensive suite of services for the pharmacodynamics and pharmacokinetics of oral thin films.
- Rich Experience: Our PK and PD services department is led by senior professionals with solid theoretical knowledge and extensive experimental experience, overseeing experimental design, implementation, biological analysis, and data analysis.
- High Standards: Our PK laboratories are GLP certified, and our experimental studies follow ICH and FDA guidelines.
Published Data
Technology: Pharmacokinetic and pharmacodynamic studies following oral administration
Journal: International Journal of Pharmaceutics
IF: 6.5
Published: 2006
Results: Oral administration of mucoadhesive tablets containing erythropoietin (EPO) and an absorption enhancer, Labrasol, was studied in rats and dogs. Pharmacodynamic studies were conducted following the oral administration of mucoadhesive tablets for six consecutive days at an EPO dose of 500 IU/kg. The increase in the percentage of circulating reticulocytes was found to be 1.7% on day 8 following oral administration. Mucoadhesive tablets showed promising results as an oral drug delivery system for protein therapeutics.
With advanced technical equipment and years of experience in oral thin films, CD Formulation provides customer-oriented services to evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) of oral thin film drugs. If you have a requirement for oral thin film PK and PD evaluation services, please contact us by phone or email, and our colleagues will reply to you within three working days.
References
- Ruiz G. A., et al. Pharmacokinetics in drug discovery. Journal of Pharmaceutical Sciences. 2008, 97 (2): 654.
- AGAH working group PHARMACOKINETICS (2004-02-16). Collection of terms, symbols, equations, and explanations of common pharmacokinetic and pharmacodynamic parameters and some statistical functions. AGAH. 2011.
- N. Venkatesan, J. Yoshimitsu, et al. Pharmacokinetic and pharmacodynamic studies following oral administration of erythropoietin mucoadhesive tablets to beagle dogs. International Journal of Pharmaceutics. 2006, Vol (310):46-52.
- Zhi-Yuan Zhang, Hua Zhang, et al. Pharmacokinetics, Tissue Distribution and Excretion of a Novel Diuretic (PU-48) in Rats. Pharmaceutics. 2018.
How It Works
STEP 2
We'll email you to provide your quote and confirm order details if applicable.
STEP 3
Execute the project with real-time communication, and deliver the final report promptly.
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