Techniques
Bioavailability / Bioequivalence
Bioavailability and Bioequivalence studies play a key role during Drug Development, for new drug products as well as their generic equivalents. Post approval too, such studies will require to be conducted when changes are carried out in the manufacturing process.
Bioavailability studies are conducted for a new drug to establish essential pharmacokinetic parameters following a single or multiple dose administration. Two formulations of a drug are considered bioequivalent if there is no significant difference in the rate and extent of absorption when the active ingredient reaches the systemic circulation. In determining bioequivalence between two formulations, pharmacokinetic studies are conducted in a cross-over study in healthy volunteers.
With tremendous experience and capabilities, AnaCipher can offer following types of studies in healthy as well as patient population
- Fasting / FedThe Fasting Study is a single arm intervention study in healthy men and women. The investigators will examine the effects of a fed state, which is 2 hours after the last food intake, versus a prolonged fasted state, which is 26 hours after the last food intake
- Parallel / Cross-overA parallel study is a type of clinical studty where two groups of treatments, A and B, are given so that one group receives only A while another group receives only B. A type of clinical trial in which all participants receive the same two or more treatments, but the order in which they receive them depends on the group to which they are randomly assigned.
- Full replicate / Partial replicate reference scaled average bioequivalence studies
- Truncated
BA/BE studies in healthy volunteers
Our expertise in conducting Bioavailability and Bioequivalence studies across wide array of dosage forms including
Solid Oral Formulations
(Tablets, Capsules, Soft Gels, and Sprinkles)
Topical Products
(Liquid orals, eg. Solutions & Suspensions)
Parenteral Formulations
(Injectables)
Inhalation Products
(Nasal and Oral Sprays)
Rectal and Vaginal Products
(Tablets, Semisolids)
