BA/BE STUDIES

Bioequivalence is a term in pharmacokinetics used to assess the expected in vivo biological equivalence of generic version to its proprietary version of a drug or formulations of innovator drug in different clinical trial phases.

Raptim has an experienced clinical team comprising trained and experienced Doctors, Pharmacologists, Pharmacists, Science post-graduates, and graduates with extensive experience in clinical research; our services include clinical conduct, monitoring, bio-analysis, project management including medical writing and statistical support as per regulatory requirements.

Healthy Subject BA/BE (Bioequivalence & Bioavailability) Studies

Raptim has conducted more than 1100+ BE studies and has about 30,000 healthy volunteer data base. The types of studies we can conduct are:

  • Single dose BA/BE studies: Fast/Fed/Sprinkled applesauce
  • Multiple doses BA/BE studies: Fast/Fed
  • Steady-state studies
  • Partial/full replicate/switch-ability design studies
  • Parallel BA/BE studies (e.g. for drugs with long half-lives)
  • Truncated BA/BE studies (e.g. for drugs with long half-lives)
  • BA/BE studies for controlled psychotropic substances
  • Long housing studies (e.g. depot injections/endogenous substances/diet restricted/teratogenic drugs
  • Comparative BA studies for different dosage forms/505(b)(2) submission types
  • Non-oral dosage form BA/BE studies:
    • Injectable
    • Topical products (semisolids, patch)
    • Inhalation (oral/nasal) products: With & without charcoal
    • Suppositories/Enema
    • Vaginal route specific dosage forms
    • Lozenges
  • Food-effect studies
  • Drug-drug PK interaction studies
  • Special population BA/BE studies
    • Post-menopausal female subjects
    • Hypogonadal male subjects
    • Geriatric subjects

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
    • Pilot studies to calculate ED50 with reference formulation or generating absorption and elimination profile with the reference formulation
    • Pivotal BE studies between test and reference formulations
  • 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 – Raptim provides test for topical formulation by Modified Draize test using occlusive/non occlusive method, comparison is done with positive and negative controls.
  • Veterinary BA/BE Studies – Raptim can conduct veterinary BA/BE studies in compliance with GLP and VICH-GCP guidelines. Raptim has extended its services portfolio in the veterinary Contract Research Organization (CRO) specializing in in-vivo studies involving companion animals to support Research and Development (R&D) for the biopharmaceutical industry.
    • 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
    • On-site experimental facility adapted to multiple animal species (rodent, non-rodent, and cattle)
    • 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.

Upcoming Projects

  • Bioequivalence study of test product versus Denamarin® (S-Adenosylmethionine and Silybin phosphatidylcholine complex (SPC)), enteric coated tablets in cats and dogs.
  • Bioequivalence study of Carbimazole tablets test product versus Vidalta–reference product in cats.