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

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

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.