BioAvailability / BioEquivalence Studies
Healthy Volunteer Studies
ICBio BA BE centre has an expertise in conducting the following types of studies:
- Fasting and Fed condition studies.
- Single and multiple dose.
- Drug-drug interaction (DDI).
- Topical Transdermal Patch Studies
- Pharmacokinetic interaction studies
- Food effects studies
- Steady state studies
- Pharmacodynamic studies
- Drugs with narrow therapeutic range
- Special populations
- Various routes of delivery
Patient Based Studies
Clinical Operations headed by Dr. Jay Rane, by qualification, he is a M.D. Pharmacology and with 25 years of illustrious work experience in the industry.
Our Clinical Operations team has a dedicated team of 15 experienced professionals in different functionalities of Project Management, Medical Writing & start-up and Medical Monitoring. This includes 2 project managers, 2 medical monitors lead by MD Pharmacology, 3 medical writers, 2 clinical team leaders, 4 CRAs and 2 regional CRAs and 1 clinical trial assistants (CTAs). As a team we have completed 48 clinical trials (Phase II, III and patient BA BE studies) in various therapeutic area such as Psychiatry, Ophthalmology, Rheumatology, Cardiology, Dermatology, and bone diseases. Our Clinical Operations team has successfully faced serval inspections at Investigator sites.
- Solid Oral Formulations & Orally Dispersible Formulation: Tablets (Immediate Release & Modified Release e.g. ER, DR, SR), Capsules, Soft Gels, etc.
- Liquid Formulations: Suspensions, Syrups & Dry power.
- Derma Patches
We have fully GLP-compliant bioanalytical facility with state-of-the-art laboratories managed by highly skilled and experienced scientific professionals and support personnel. All analytical methods are developed and validated in line with current international regulatory requirements with assurance of precision recovery and stability checks. While all systems use validated software that is CFR 21 Part 11 compliant with all bioanalytical services ensure the highest of quality standards and in compliance with guidelines. All data is electronically transferred and documented and all studies are scrutinized by the QA Department and subjected to periodic in-house audits to ensure compliance.
Our bioanalytical staff provides technical services to national and international Pharma companies. Bioanalytical has capacity to analyze >8000 samples per Month. Our bioanalytical team has a proven regulatory track record and regulatory compliant environment to fulfill regulatory and sponsor's satisfaction.
ICBio clinical research provides bioanalytical services to support clinical studies. Our experienced scientists offer a full range of LC/MS/MS bioanalytical services, from method development, method validation, and sample analysis as per regulatory requirement. Our LCMSMS machines and can analyze samples using multiple machines thereby reducing the overall days of analysis in some time bound studies
- Method development and validation for a wide range of drug substances
- Quantitative analysis at picogram /mL concentrations
- Complex bioanalysis of bound and Total drug
- Hormones and vitamin analysis.
Facility and Instrumentation:
State-of-the-art laboratory facilities for bioanalysis spread over 3,000 sq ft is equipped an instrument lab and a sample processing area with cutting edge capabilities, multiple equipment’s and technology to ensure project completion with quick-turnaround time. The Bio-Analytical data is electronically transferred and stored on Bioanalytical server. The server is backed Up by mirroring on another server.
- Access controlled Freezer room for sample storage has power back up and 24*7 temperature Monitoring and alarm system, with -20°C Freezer and -80°C ULTF.
- Access controlled entry and exit facility.
- Separate sample processing laboratory.
- LC-MS/MS laboratory.
- ICP – MS (Perkins Elmer) laboratory.
- High end processing lab.
- Sensitive machines like LC-MS/MS Shimadzu 8040, Shimadzu 8050 to achieve the pg levels.
- Analytical and Microbalance
- Solid Phase Extraction Systems (48 well plated)
- Nitrogen Evaporators
- Refrigerated Centrifuges
- Smart Scan Temperature recording system
- Lab Solution software for LCMS/MS Systems
- All our systems use validated software that is CFR 21 Part 11 compliant.
- Quality Assurance
- Quality management provides quality systems which in turn guarantee good quality data in each clinical trial. Quality systems implemented at ICBIO and managed by Quality Management ensure the quality, integrity, and accuracy of data for each clinical study undertaken at ICBIO.
- Clinical Development
- Clinical Development team conducts Phases II-IV clinical trials for pharmaceutical and biotech companies, maintaining the highest standards of ethics, quality and confidentiality. A team of well-trained professionals, experience in project management in various therapeutic areas.
- Bio Analytical
- ICBio management & operations team brings in considerable experience in conducting BA/BE studies on healthy as well as patient population with various dosage forms including injectables like IM/IV/SC, oral dosage forms like solid formulations (Modified Release preparations), liquid formulations, topical preparations and inhalations. The BA/BE studies conducted at ICBio are fully GCP compliant.
- Project Management
- ICBIO's project management group stands out from other CROs in an industry where hard deliverables and quality of enrollment are everything. ICBIO project managers throughout the globe are obsessive about on-time project delivery from day one.
- Our focus is to ensure the integrity of your data and organize your findings and conclusions into a clear and results-oriented presentation. Our bio statistics for clinical research and statistical programming services include pre-analysis, analysis and post-analysis.