Bioequivalence Testing
Bioequivalence testing is critical to gain regulatory approval for non-NDA submissions. Choosing the right nonclinical test system can help sponsors get their product through the approval process more efficiently by reducing the amount of clinical testing required.
Generic drugs represent over 80% of prescriptions in the US, and can alleviate drug shortages, reduce costs, and enhance patient access to treatment. Regulatory approval of new generics requires proof of bioequivalence (BE). Our suite of BE assays from simple in vitro permeability to in vivo pharmacokinetics provide exceptional, robust data to support these applications.
FREQUENTLY ASKED QUESTIONS
What dose routes do Absorption Systems support for bioequivalence studies?
We support a full range of dose routes and have systems of increasing complexity with which to study these. A snapshot of these assays is shown in the table below:
| Dose Route | In vitro | Ex vivo | In vivo |
| Oral |
Caco-2 Combined dissolution absorption (iDAS) |
Intestinal perfusion Tissue permeability |
Standard PK Ported animals |
| Intra-oral (Buccal/Subligual) | 3D tissue equivalent | Tissue permeability |
Sublingual dosing |
|
Dermal |
IVRT | Skin permeability |
Dermal dosing (topical, patches) Disease models |
| Ocular | MDCK | Corneal/Conjunctival tissue permeability |
Ocular dosing (topical, intravitreal) Disease models |
| Intravaginal | 3D tissue equivalent | Tissue permeability | Vaginal dosing (topical, suppository) |
What are complex generic drug products?
Complex generics are drugs with either non-standard active ingredient, formulation or route of delivery. For example, a topical skin product may have multiple formulations based on reactions with the dermis. These differences have important consequences for bioequivalence studies.
REGULATORY CONSIDERATIONS
In general, we offer expert guidance and experimental studies to support all regulatory approval routes for drug products. Bioequivalence studies are particularly important for ANDA and 505(b)(2), for which there may already be approved products to be used for reference.
Does the FDA support complex generic drug products (CGDPs)?
The FDA has clearly prioritized the accelerating of CGDPs to market. They recognise that the products ‘ by nature of their formulation, delivery systems or the complexity of their active ingredients, for example, are harder to “genericize” under traditional approaches.’ (FDA, 2019).
Addressing this requires the development of reliable and reproducible scientific tools to help understand chemical and biological complexity and establish bio-relevant assays.
