ECRON ACUNOVA
 
 
 
Bioavailability and Bioequivalence Services (PK/PD)
 

Bioavailability and Bioequivalence Services (PK/PD) at Ecron Acunova

 

Based on GCP and GLP compliance BA / BE studies are conducted at EA. Marketing Authorization has been awarded by the US FDA, Health Canada, EMA, MHRA, TGA, MCC, Thai FDA, DCGI and WHO.

       

Service Offering



We offer end-to-end services including: regulatory consulting, IP import, protocol design, ethics committee submissions, screening, clinical study execution, bio analytical testing, pharmacokinetic, statistical analysis and report writing. We have proven expertise in clinical study management, method development and validation, data management with Oracle Clinical, PK analysis using Phoenix WinNonlin, statistical analysis using SAS and CDISC compliant reports in eCTD formats.

Wide Range of Studies



BA / BE studies for generic molecules and intensive PK/PD studies for NCEs are conducted in normal healthy volunteers and patients. We have access to Caucasian and Mongoloid subjects. Studies can be at single center or multi center. We have also conducted studies for regulatory pathways like 505 b (2) and Clinical Endpoint BE. Variety of dosage forms including: tablets, capsules, suspension, ODT, sub-lingual, topical emulsion, spray, inhaled vapor, transdermal patches, injectables etc. Study designs include: first-in-man, dose finding, PoC, drug interaction, food effect, bridging, reference scaled average BE design, two stage adaptive EMA design etc.

We can analyse in multiple matrices including: blood, plasma, urine, skin and bone. We have experience in highly variable molecules, hormonal products and analysing trace elements at parts per trillion. We serve global companies in the Pharma, Biotech and Nutrition industry from US, Canada, Europe and Asia.

Clinical Pharmacology Centers



Our clinics are located at multi-specialty teaching hospital campus ensuring the highest standards of safety. The clinics are audited by DCGI and international regulators and are self-identified with US FDA as per GDUFA. Clinic design allows mixed gender studies as well as light sensitive molecules.

Equipped with an advanced ICU to handle emergencies, AE clinics are centrally air-conditioned, access-controlled with dedicated areas for screening, counselling, housing, phlebotomy, pharmacy and recreation & dining rooms. The ICU beds are equipped with defibrillators, ventilators, cardiac monitors, oxygen supply, crash cart and required emergency medicine.
Our clinics are designed to meet highest standards of volunteer safety and comply with DCGI specifications. We have access to additional clinics in France, Jordan, China, Thailand and India to meet client needs for marketing authorizations in these areas.

Institutional Ethics Committee



Prior to conduct, all studies are approved by Manipal University Ethics Committee which is registered with the office of Human Research Protection, US Dept. of Health & Human Services and DCGI. It has the distinction of being ‘first in country’ to be accredited by Association for Accreditation of Human Research Protection Program (AAHRPP Inc.).
 

Analytical Service



We have an in-house GLP compliant analytical lab with a bank of LCMS/MS and additional instruments such as Flow Cytometry, ICP-MS, and Automated blood coagulation analyzers. Our Analytical experts reputed for quick turnaround have developed hundreds of methods (including many challenging methods) in different matrices. Additionally, our PK expert’s opinion is often sought by formulators to make improvements to their difficult molecules.

Study Team and Volunteer Access



Our study teams have many years’ experience conducting studies and consists of both MDs in the clinic and Pharmacy PhDs in the lab.

We have a database of over 15,000+ volunteers including post-menopausal women and geriatric volunteers. Located in super-specialty hospitals, we have access to oncology, psychiatry, dermatology, diabetics and renal impaired patients. ISO-certified Clinical Testing Laboratories accredited by the College of American Pathologists and NABL ensure volunteer inclusion with protocol compliance. Our lab is located in the same facility as the clinic ensuring quick turnaround.

Regulatory Compliance and Quality Assurance



We have an independent QA department ensuring study compliance to current guidelines with SOP’s, training and audits. Periodic certification to ISO 9001, ISO 27001, ISO 15189, 21 CFR part 11 provides further assurance.

Based on our study data regulatory authorities in US, European Union, UK, South Africa, Latin America, India and SEA have granted marketing approvals for multiple molecules.

Key Differentiators

Our reputation excellent quality, on time delivery, at competitive cost, with personalized service has earned us exceptional customer loyalty.

Be Ahead of Guidelines with EA®

Links to WHOPIR, FDAEIR & Brochures

WHO PIRs


FDA EIRs


FDA GDUFA identifiers


Bioanalytical Method library


BABE brochure

 
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BA/BE | PK/PD
Service Offering
Wide Range of Studies
Clinical Pharmacology Centers
Institutional Ethics Committee
Analytical Service
Study Team and Volunteer Base
Regulatory Compliance and Quality Assurance
Key Differentiators
 
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For capability presentation and further information, please contact:
UNITED STATES
pkpd@ecronacunova.com
ASIA
babe@ecronacunova.com
EUROPE
phaseone@ecronacunova.com
 
 
  • BABE /
  • PK PD and Patient Studies /
  • Phase I, II, III /
  • LC-MS /
  • XEVO TQS /
  • NABL /
  • DCAT /
  • GPHA /
  • CPHI /
  • USFDA /
  • EMA /
  • ANSM /
  • TGA
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