BA/BE (Bioavailability &
Bioequivalence) 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
(Bioavailability & Bioequivalence) Studies
Raptim has conducted 3000+ 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
BA/BE studies for controlled psychotropic substances
Non-oral dosage form BA/BE studies
Steady-state studies
Partial/full replicate/switch-ability design studies
Injectable
Topical products (semisolids, patch)
Parallel BA/BE studies (e.g. for drugs with long half-lives)
Long housing studies (e.g. depot injections/endogenous substances/diet restricted/teratogenic drugs
Truncated BA/BE studies (e.g. for drugs with long half-lives)
Comparative BA studies for different dosage forms/505(b)(2) submission types
Inhalation (oral/nasal) products: With & without charcoal
Suppositories/Enema
Vaginal route specific dosage forms
Vaginal route specific dosage forms
Vaginal route specific dosage forms
Vaginal route specific dosage forms
Post-menopausal female subjects
Hypo gonadal male subjects
Food-effect studies
Geriatric subjects
Biologics and Biosimilars: Method Development and Validation: Anti-drug antibody (ADA) and neutralizing antibody (NAb) testing
Biologics and Biosimilars: Immunogenicity assays / Assay Characterization
Manufacturing & Marketing
Single dose BA/BE studies: Fast/Fed/Sprinkled applesauce
Single dose BA/BE studies: Fast/Fed/Sprinkled applesauce
- a. Pharmacokinetics
- b. Immunogenicity
- c. Pharmacodynamics