BIOAVAILABILITY & BIOEQUIVALENCE

DCGI approved BA BE centre in Bangalore

Capability

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.

ICBio has the capability to recruit special volunteer groups for study specific needs like hypertensive volunteers, renal failure volunteers, post-menopausal and old age population etc. through partnerships with hospitals and clinics.

ICBio has a strong SOP driven culture and ensures compliance with all statutory and mandatory requirements and supports the regulatory queries arising post submissions.

We provide our clients a dedicated Project management team to serve as a single point of contact.

Infrastructure

The BA/BE facility mainly comprises of the following critical areas of operations

  • Registration and Screening unit
  • Pharmacy
  • Clinical Ward
  • ICU
  • Bioanalytical laboratory
  • Quality Assurance unit

Pharmacy

Pharmacy is access controlled and is equipped with a Stability chamber programmed at 23±2℃ and 60±5 ℅ RH and is used for storage and retention of the investigational products.


Other equipments include the following;

  • Laminar Air flow for dispensing
  • Analytical balance for weighing of liquid investigational products
  • GPS enabled digital clocks for uniform time recording

Registration and Screening unit

The registration facility is designed to facilitate the registration and screening of the volunteers willing to enroll in the study. Registration of the volunteers is controlled by a biometric based & audit trail enabled in-house volunteer management system. ICBio has large number of volunteer database of both male & female (healthy & patient population)

Registration and Screening unit is supported with an in-house path lab for analysis of screening samples.

Following areas have been demarked to ease the movement of the volunteers during the activity

  • Volunteer waiting lounge with recreation facilities
  • Prescreening
  • Registration
  • ECG
  • Blood and Urine sample collection
  • Clinical examination

Following areas have been demarked to ease the movement of the volunteers during the activity

  • Volunteer waiting lounge with recreation facilities
  • Prescreening
  • Registration
  • ECG
  • Blood and Urine sample collection
  • Clinical examination

Supporting critical equipments include the following;

  • Weighing balance
  • Height measurement scale
  • Biometric and audit trail enabled volunteer management system
  • GPS enabled digital clocks for uniform time recording

Clinical ward

The Clinical ward area is state of the art housing facility with 24 beds and CCTV monitoring. Supporting demarked areas include the following;

  • Consent area with individual consent rooms equipped with audio-video recording through CCTV
  • Urine drugs of abuse & Alcohol breath
  • Change room with locker facility
  • Bathroom
  • Dosing & Vitals
  • Doctor & Monitors
  • Phlebotomy
  • Sample separation & storage
  • Dining
  • Entertainment

ICU

ICU is designed for quick evacuation during an emergency. It has the following equipments


  • Fowler Beds
  • Crash cart
  • Multipara monitor
  • Ambubag
  • Defibrillator
  • Suction apparatus
  • Emergency medicines
  • Oxygen cylinder

ICBio has tie up with a multi-specialty hospital to handle emergency and is backed with an in-house ambulance.

Bioanalytical Laboratory

State of the art bioanalytical laboratory is equipped an instrument lab and a sample processing area. Supporting equipments include the following;

  • LC-MS/MS
  • Deep freezer (-80℃)
  • Refrigerated Centrifuge
  • Microbalance
  • Analytical balance
  • Nitrogen evaporator
  • Solid Phase Extraction unit
  • Micropipettes

Quality Assurance Unit

The QA team ensures SOP compliance in line with the current regulatory requirements and has dedicated team for audit of clinical and bioanalytical phases of the study. QA ensures conduct of audit during various phases of the study - In-process & Retrospective. QA also carries out System and Facility audit, Vendor qualification audits. QA ensure training of every personnel before their participation into designated activity.

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