Special studies
In-Vivo
Tape Stripping
Raptim can provide relative expertise in quantifying the amount of drug available at stratum corneum at a particular time point.
Quantification of the drug in stratum corneum layer of skin
Applicable for topical drugs not quantifiable through systemic absorption.
Pivotal BE studies between test and reference formulations
Pilot studies to calculate ED50 with reference formulation or generating absorption and elimination profile with the reference formulation
In Vivo
Tape Stripping
Raptim can provide relative expertise in quantifying the amount of drug available at stratum corneum at a particular time point.
Quantification of the drug in stratum corneum layer of skin
Applicable for topical drugs not quantifiable through systemic absorption.
Pivotal BE studies between test and reference formulations
Pilot studies to calculate ED50 with reference formulation or generating absorption and elimination profile with the reference formulation
Glucose Clamp Studies
Raptim Research can support Glucose Clamp Studies for our sponsor and we have experienced team to manage these studies at our setup. As per the regulatory requirements, the pharmacodynamic data on time-actions profiles using the Glucose Clamp procedure should be available for bio-similar insulin preparations, including pre-mixed insulins. In addition there is a general agreement among experts that the Glucose Clamp procedure is one of the best available solutions for the assessment of insulin action.
In the Glucose Clamp experiment, by means of a variable infusion of glucose, the blood-glucose lowering effect of a drug (like insulin or oral antidiabetic agent) is antagonised. This enables the blood glucose concentrations to be maintained or “clamped” at a predefined target level. Raptim has a well-controlled environment and setup for Glucose Clamp studies.
Clinical Investigator and the staff is well trained in Glucose Clamp Studies, we can do 10-12 clamps/week
Glucose Clamp Studies
Raptim Research can support Glucose Clamp Studies for our sponsor and we have experienced team to manage these studies at our setup. As per the regulatory requirements, the pharmacodynamic data on time-actions profiles using the Glucose Clamp procedure should be available for bio-similar insulin preparations, including pre-mixed insulins. In addition there is a general agreement among experts that the Glucose Clamp procedure is one of the best available solutions for the assessment of insulin action.
In the Glucose Clamp experiment, by means of a variable infusion of glucose, the blood-glucose lowering effect of a drug (like insulin or oral antidiabetic agent) is antagonised. This enables the blood glucose concentrations to be maintained or “clamped” at a predefined target level. Raptim has a well-controlled environment and setup for Glucose Clamp studies.
Clinical Investigator and the staff is well trained in Glucose Clamp Studies, we can do 10-12 clamps/week
Vivo Dermal Microdialysis
Raptim can provide relative expertise in quantifying the amount of drug available at the Dermis layer at different time points. The procedure involves inserting a catheter in dermis/epidermis layers of the skin.
Quantification of the drug in the dermal layer of skin
Applicable for topical drugs with low to moderate protein binding.
Skin Blanching
Studies
Raptim can provide the measurement of vasoconstriction assay (VAS) of cortocostroid products using Chromameter. Skin Blanching Assay or Vasoconstriction can be used to demonstrate the bioequivalence of topical corticosteroids.
Skin Irritation and
Sensitization Test
Veterinary BA/BE Studies
All our animal studies are in compliance with Good Clinical Practices and Good Laboratory Practices (GLP).
(VICH-GCP) in target animal species – cats, dogs, cattle, and horses.
Dedicated and experienced staff with scientific knowledge for veterinary medicines.
Quality: Full-featured and audited quality management system, providing high-quality services with maximum flexibility.
Wide access to veterinary/animal breeding facilities.
Off-site and On-site collaboration with Board Certified and highly qualified veterinary specialists.
Quality: Full-featured and audited quality management system, providing high-quality services with maximum flexibility.
Development and validation of analytical methods for veterinary drugs in biological matrix.
Biostatistics and statistical programming.
We have experience conducting Bioequivalence study of cyclosporine capsule 100 mg, USP modified in beagle dogs