Bioavailability and bioequivalence services

Bioanalytical Services

Cepha Phase I services

Pharmacokinetic Data Evaluation

cepha Phase II-IV Clinical Trials

CEPHA: Bioavailability and bioequivalence services, Bioanalytical Services, Cepha Phase I services, Pharmacokinetic Data Evaluation, cepha Phase II-IV Clinical Trials.

CEPHA has established its reputation for conducting high-quality, time and cost effective bioequivalence and bioavailability studies. Currently, CEPHA is the leading CRO in the Czech Republic providing a broad range of clinical research services. To those who work with them, personal attention of local CRO staff is paid to every detail of the project hand-in-hand with the procedures, technologies and reporting of globally oriented company. They deal in Bioavailability and bioequivalence services, Bioanalytical Services, Cepha Phase I services, Pharmacokinetic Data Evaluation, Phase I and cepha Phase II-IV Clinical Trials.

Bioavailability and bioequivalence services

Bioavailability and bioequivalence services single/multiple doses, Bioavailability and bioequivalence services fasted/fed conditions, Bioavailability and bioequivalence services immediate/modified-release preparations, Bioavailability and bioequivalence services various dosage forms/routes of administration and Bioavailability and bioequivalence services healthy volunteers/special population are available.

Bioanalytical Services

Bioanalytical Services and bioanalytical laboratory of CEPHA are fully in compliance with OECD GLP Principles. Bioanalytical Services comprise highly selective and sensitive assays of drugs, metabolites and endogenous compounds in biofluids of human and animal origin. With the help of a growing list of developed analytical methods, time and cost effective analysis and Bioanalytical Services of samples is offered. With the latest HPLC and GC instrumentation and full implementation of QC & QA procedures CEPHA lab produces top quality data and Bioanalytical Services.

Cepha Phase I services

Cepha Phase I services are offered by CEPHA. Cepha Phase I services are provided either as integrated or on a stand-alone basis. These include, Cepha Phase I services first-in-man, Cepha Phase I services safety/rising dose tolerance, Cepha Phase I services drug-drug interaction studies and Cepha Phase I services healthy volunteers/renally & hepatically impaired patients.

Pharmacokinetic Data Evaluation

Pharmacokinetic Data Evaluation is provided based on the individual data of drug concentration. This service includes, Pharmacokinetic Data Evaluation – determination of all pharmacokinetic parameters, Pharmacokinetic Data Evaluation – individual data listing, Pharmacokinetic Data Evaluation – descriptive statistics of all parameters including SDs and CVs, Pharmacokinetic Data Evaluation – analysis of variance (ANOVA), Pharmacokinetic Data Evaluation – parametric (non-parametric) 90% confidence interval, Pharmacokinetic Data Evaluation – normality and homogeneity testing, Pharmacokinetic Data Evaluation – power analysis.

cepha Phase II-IV Clinical Trials

cepha Phase II-IV Clinical Trials are performed with full-service clinical trials planning, management and interpretation under GCP conditions. Their relations with hospitals and clinical units in a variety of clinical research areas enable a timely and cost-effective cepha Phase II-IV Clinical Trials management. cepha Phase II-IV Clinical Trials include clinical trial planning including statistics, study protocol writing, designing of CRFs, management of Independent Ethics Committee reviews, recruitment of investigators, study monitoring by experienced CRA personnel, data handling and evaluation, record keeping and reporting of study results.