A specialized center for the evaluation of the safety and efficacy of drugs with emphasis on the bioequivalence studies.
The Bioavailability / Bioequivalence Center
The Bioavailability / Bioequivalence center is one of the centers entitled with special functions in NODCAR.
To evaluate the clinical efficacy and biological activity of a product, In-Vivo human health volunteers studies are done. At the same time, In-Vitro dissolution and disintegration tests are run in parallel with the clinical studies to ensure the conformity of the products from the clinical and pharmaceutical points of view.
Studies performed at the center are in accordance with the internationally accepted criteria and ethics and follow the guidelines of the reputable agencies as the FDA and WHO.
Bioequivalence evaluation of products, generics and raw martial is sometimes requested to assure the compliance of the tested material with a renowned standard equivalent. The outcome of these studies will allow substitution of expensive brands with less costly and similarly effective ones and thus leads to rationalization of use of drugs and elimination of sub-standard brands. The center extends its services to pharmaceutical Manufacturers in Egypt and some Arab countries.
In-vitro Dissolution Studies:
- Biowaivers and comparative in-vitro dissolution.
- Method development and validation,
- Drug and metabolite determination in biological fluids.
Bioequivalence and Bioavailability Studies:
- Pharmacokinetics and Statistical Data Evaluation
DBC in NODCAR is equipped with all the facilities that are necessary for achieving its different goals.
- Fully qualified medical and analytical team.
- Volunteers Room (A fully equipped 24 bed air conditioned room).
Some of the available equipment includes:
The most sensitive adopted technique for quantitative bioanalysis
- TQD (Tandem Quadrupole Detector) features the highest levels of tandem quadruple MS sensitivity and selectivity of UPLC/MS/MS.
- This generates accurate and reliable data that can be used for a variety of different purposes, including Bioequivalence studies.
- It is used in pharmacokinetics studies of different pharmaceutical products due to high sensitivity, specificity and shorter time of analysis.
- It is used to quantify very small amounts of compounds measured in nanograms and even in picograms.
- The applied sample may be plasma, serum, urine or non-aqueous solution HPLC
HPLC Connected to UV Detector
- Capable to separate, identify, and quantify compounds based on their relative polarities and interactions with the column’s stationary phase.
- It provides high performance, high speed, and high productivity in preparative chromatography
- The sample may be plasma, serum, urine or non-aqueous solutions.
HPLC Connected to Flourimetric Detector
- Reliable and robust.
- Unique timesaving features including automatic start.
- Meets all current USP, JP and EP requirements
- Measures and records temperature in each vessel
- Used to determine compliance with the dissolution requirements for solid dosage forms into dissolution media simulating the in vivo condition such as simulated gastric fluid (pH 1.2) or simulated intestinal fluid (pH 6.8).