Applying all In-vivo (bioequivalence and bioavailability studies) and in-vitro (dissolution, disintegrating, friability, hardness, stability, drug potency and content uniformity, and weight variation) pharmaceutical drug testing according to the international guidelines.
BIOEQUIVALENCE TESTING
BIOANALYSIS
All bioanalytical projects are approached with a focus on excellence, efficiency and speed. Our goal is to consistently provide the best possible analysis in the shortest time while maintaining full compliance with all regulatory requirements.
BIOANALYTICAL SERVICES
Method development.
Method validation.
Method transfer
HPLC Analysis of drug and metabolites in biological fluids from clinical trials & bioequivalence.
LC/MS/MS Analysis of drug and metabolites in biological fluids from clinical trials & bioequivalence.
SERVICES FOCUS
Analytical Laboratory features the latest bioanalysis equipment and technologies and a specialized Method Development Group of scientists committed to developing methods with the lowest LLOQ and very rapid turnaround times. We offer non-exclusive methods for drugs in all major therapeutic areas, ready to be used with a short
lead time to analyze drugs and metabolites in biological fluids.
LABORATORY FACILITIES
LC/MS/MS instruments (AGILENT 6410- U.S.A.).
High performance liquid chromatography with UV detector (THERMO- U.S.A).
High performance liquid chromatography with Diode array detector (THERMO- U.S.A.).
Spectrophotometer (THERMO- U.S.A.).
Dissolution tester (Labindia).
Friabilator (Labindia).
Desintegrator (Labindia).
Hardness tester (Labindia).
Electric ovens, Centrifuges, Vortex, Vacuum pump, Micropipettes,Magnetic stirrer.
Ultra-purified water system (ELGA-U.K.)
Networked chromatographic data management system, including dedicated servers for HPLC and LC-MS/MS data.
Validated Temperature and Humidity Monitoring System.
UPS (Uninterrupted Power Supply).
CLINICAL FACILITIES
- The centre is contracted with a nearby hospital for emergency cases.
- Well training and highly professional physicians.
- A professional registered nurse(s) responsible for cannulation and blood sampling for blood sampling.
- Physician room (including first aid measures) for physical examination of the volunteers.
- Separate sampling room.
- A contract with a licensed waste destroyer and burner for picking up the blood, plasma wastes and other wastes twice a week.
- A controlled- closed area for wastes.
-Sampling room for blood sampling and drug administration.
-Destroyer syringe equipment is used for syringe disposable procedures. SOPs of all the clinical trial is well written and well done during the
study procedures as assured by the quality assurance manager.
-A well established kitchen for preparing a standardized meals for the volunteers.
-An entertainment area for the volunteers.
- Informed consents and medical case report sheet approval for volunteer fitness for the studies.
PHARMACOKINETICS AND BIOSTATISTICS
Biostatistics department can assist the sponsor in the design, analysis and interpretation of study data. Our expert biostatisticians have broad experience in various aspects of clinical trials within the drug development arena, from sample size calculation and design issues at the planning stage, to analyzing, displaying and interpreting data in the final stages of the study.
The PK/PD and Biostatistics department at our centre are involved in the study from the initial stages right through to final report. They ensure that the study design and statistical plan are created to answer the study objectives. During the studies they are actively involved in all safety discussions to provide input as needed.
QUALITY ASSURANCE SYSTEM
Our own SOPs ensures that our procedures, systems, and associated documentation and controls comply with regulatory GCP, ISO 9001: 2008 and ISO/IEC 17025:2005 standards. To ensure the integrity and accuracy of the study data all documents and records are subject to QA processes. Our QA role extends beyond auditing to provide education and training of the staff.
ACCREDITATION:
DRC has been Certified and Accredited in compliance with:
1- ISO 9001:2008
2- ISO / IEC 17025:2005