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Glucose Clamping Studies

Home Glucose Clamping Studies

Regulatory agencies require Pharmacokinetic and pharmacodynamic data on time-action profiles for new or biosimilar insulin preparations, using the glucose clamp procedure”

Services Offered

  • ADVITY team of highly experienced clinical experts have longstanding expertise in developing protocols and related documents for glucose clamping studies.
  • Insights in study design and PK & Stat aspects of the protocols.
  • ADVITY Regulatory Affairs Team provides project management for in collation of documents, submission, and representation of the client at meetings with regulatory agencies.
  • Regulatory documents compilation
  • Regulatory application filing
  • Experienced expert Physicians who specially trained for the clamping studies.
  • In-house expertise in design and conduct of clamp.
  • Our capacity supports extended glucose clamp studies.
  • Qualified, 21CFR Part11 Compliant analyzer with redundancy.
  • ​Expertise in ensuring precise euglycemic glucose clamp technique.
  • Constant safety monitoring of subjects during the conduct of the study.
  • State-of-the-art facility can accommodate studies lasting more than one week with 24/7 medical support.
  • Validated methods for estimation of Insulin /analogs /metabolites.
  • Robust analytical procedures.
  • Estimation of Insulin and C-peptide using ELISA.
  • ​Experienced analytical scientists.
  • Analytical platforms like Ligand binding assays, chromatographic assays.
  • An understanding of key technical considerations for rigorous data analysis (Pharmacokinetic considerations.
  • Regulatory compliance report generation in a quick turn around time.
  • Statistical considerations especially for differentiating exogenous Insulin from endogenous).

State-Of-The-Art Facilities

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  • A state-of-the-art facility spanning approximately 42,000 sq. ft., well-connected to all major parts of the city.
  • Comprehensive emergency infrastructure to ensure the safety and emergency handling of participants.
  • A volunteer cross-participation verification system to ensure right participants take part in the study.
  • In-house developed eDC tool for seamless data capture without integrity issues.
  • Clinical pharmacology units with bed capacity to accommodate 10,000 doses per year.
  • Additional clinical pharmacology units under development to accommodate an additional 8,000 doses per year.
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  • State-of-the-art Intensive Care Unit with modern infrastructure to handle basic emergency requirements during clinical studies.
  • A In-house X-ray and ECG facilities.
  • Partnership with a tertiary care hospital for emergency handling.
  • Association with NABL accredited path labs to select the right participants for the study.
  • Humidity chambers for the storage of investigational products.
  • Archival facility with sufficient space for future expansion.
  • State-of-the-art bioanalytical facility with advanced analytical infrastructure.
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  • Advanced LC-MS/MS systems to accommodate bioanalytical methods up to 1 pg/ml.
  • Deep freezers to store extended volumes of biological samples.
  • State-of-the-art large molecule analytical facility – ELISA.
  • Eurotherms installed across the analytical facility to monitor temperatures.
  • Cutting-edge IT infrastructure with SonicWall firewalls, Dell servers with RAID-5 configuration, NAS storage with RAID-5, and Kaspersky Antivirus for robust security.
  • SAS version 9.4 system fully validated.

Experience & Expertise

15 Years

Our team includes glucose clamp scientists with over 15 years of experience in insulin formulation studies.

Team

Analytical scientists with experience and robust methods and infrastructure to estimate insulin and C-peptide levels.

Execution

Dedicated work force (Medical monitors, CRAs, Nurses and Phlebotomists) for execution of glucose clamping studies.

Formulations

Insulin Glargine 40 IU/mL, Insulin Regular Human 100 IU/mL, Insulin Isophane Human 100 IU/mL, Biphasic Isophane Insulin 30/70 IU/mL.

Discuss your clinical Insulin biosimilar developmental plans with our Clamping expert

Vasudev Sureddy - Executive Director & COO
+91 40 69089999
bd@advityresearch.com