BioAvailability / BioEquivalence Studies

DCGI Approved CRO in Bangalore

BA/BE Studies are conducted at ICBio are in strict Compliance with International Regulatory Requirements, monitored by an independent quality assurance department.

ICBio management & operations team brings in considerable experience in conducting BA / BE studies on healthy as well as patient population with various dosage forms.

Our Bio Studies includes various BA/BE Studies, Phase I Studies and PK / PD Studies. We have active volunteer database of 10000 volunteers, including healthy volunteers, special populations and female volunteers.

PK / PD & Patient Studies

We offer services to conduct Pharmacokinetic and Pharmacodynamic studies / clinical endpoint studies on healthy volunteers and Patient Population to assist our clients with their drug development programs.

Phase I Studies on Healthy Volunteers:

We have Capabilities to Conduct Phase I Studies on Healthy Volunteers and offers Phase I studies like First-in-Man for new chemical entities (NCEs) and new biological entities (NBEs). We also offer services on clinical pharmacology studies including Food Effect, Proof of Mechanism & Proof of Concept, Drug Interaction studies, Pharmacokinetic / Pharmacodynamic studies, exploratory studies for various biomarkers and various Special Population studies.

Bioanalytical Services

We offer comprehensive bio-analytical services that include method development & validation from several human matrices such as blood, serum, plasma & urine, analyze complex molecules for Phase I plasma samples.

We have a dedicated team to develop validated more than 120 methods. This team is competent to develop and validate a minimum of 4 methods every month. This translates into faster turn-around time for development and validation for new molecules.

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.

Infrastructure

our analytical facility is spread over 2,000 sq ft is equipped an instrument lab and a sample processing area with cutting edge capabilities that comprise LCMS/MS. Our lab is equipped with HPLC units in addition to Auto Samplers Biological Sample Extraction units Ultra Water Purification system spacious wet labs with positive & negative pressure sample extraction unit, air handling units, Nitrogen evaporator, Analytical balance, Microbalance, fume hoods and more. We do have separate Bioanalytical lab space for processing light sensitive molecules.

The validated and regulatory compliant software@ ICBio ensures movement of data from the analytical lab to documentation within a CFR Part 11 compliant environment.

All study samples are stored in secure freezers with temperatures ranging from 2째- 8째 C, - 20째 C and -80째 C. These freezers are monitored round the clock with power backup and can store huge samples.

Formulations

  • Solid Oral Formulations & Orally Dispersible Formulation: Tablets (Immediate Release & Modified Release e.g. ER, DR, SR), Capsules, Soft Gels, Sprinkles etc.
  • Liquid Formulations
  • Suspensions, Syrups & Dry power
  • Parenteral Formulations
  • Sprays
  • Oral Inhalation
  • Derma Patches
  • Transdermal preparations
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Departments
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.

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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.

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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.

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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.

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Biostatistics
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.

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