In-Vitro-Bioequivalence
Overview
Integrated in vitro bioequivalence support across oral, topical, transdermal, nasal, inhalation, injectable, and nanomedicine products.
Capabilities include dissolution and release testing, IDR, IVRT, IVPT, permeability studies, spray and particle characterization, binding assays, cyclodextrin inclusion studies, and softgel rupture testing.
Services
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Solid Oral Dosage Forms
Support for dissolution, release, permeability, and formulation screening across conventional and complex oral products.
Comparative dissolution and method development
IDR studies
Flow-through cell and biorelevant release models
Permeability screening and formulation ranking
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Topical and Semisolid Products
Support for Q3 characterization, IVRT, IVPT, and topical in vitro bioequivalence programs.
Microstructure and rheology characterization
IVRT method development and validation
IVPT study design and execution
Comparative performance assessment
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Nasal Spray and Inhalation Products
In vitro performance testing, device comparability assessment, and regulatory support for OINDPs.
Delivered dose uniformity and single actuation content
DSD and APSD studies
Spray pattern and plume geometry
IVBE support packages
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Transdermal Delivery Systems
Release, permeation, and product consistency testing for patches and dermal systems.
In vitro permeation testing
Drug release studies
Adhesion and physical characterization
Reference product comparison
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Softgels and Lipophilic Systems
Rupture and release studies for soft gelatin capsules and other lipophilic dosage forms.
Quantitative rupture testing
Dissolution and release profiling
Flow-through cell studies
Bridging and comparative assessment
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Complex Injectables and Nanomedicines
Analytical and performance testing for complex injectable and nano-enabled products.
In vitro release studies
Particle or globule size characterization
Formulation comparability assessment
Product-specific development support
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Binding and Inclusion Models
Targeted in vitro models for products where binding or inclusion behavior drives performance.
Phosphate and bile salt binding studies
Protein and pepsin binding assays
Cyclodextrin inclusion studies
Release and kinetic assessment
Technical Capabilities
A focused in vitro platform for oral, topical, transdermal, nasal, inhalation, injectable, and specialty products.
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Dissolution and Release
Core Capabilities: Comparative dissolution, release profiling, flow-through cell studies, rupture testing
Value: Supports formulation screening, comparability assessment, and submission-ready data generation.
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API and IDR
Core Capabilities: IDR studies, API dissolution characterization, preformulation support
Value: Helps evaluate developability and guide early formulation decisions.
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Topical and Transdermal
Core Capabilities: IVRT, IVPT, vertical diffusion cells, permeation studies, Q3 evaluation
Value: Ideal for semisolids and patches requiring local performance and microstructure assessment.
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Permeability and IVIVC
Core Capabilities: Dissolution-permeability systems, absorption screening, formulation ranking
Value: Useful for biowaiver planning, excipient risk evaluation, and lead selection.
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Nasal and Inhalation
Core Capabilities: DDU, DSD, APSD, spray pattern, plume geometry, device-product comparability
Value: Built for OINDPs that require IVBE support and multi-attribute comparative evidence.
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Complex and Specialty Products
Core Capabilities: Release testing, particle characterization, binding assays, inclusion studies
Value: Supports complex injectables, nanomedicines, and specialty formulations with product-specific needs.
Featured Strengths
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Submission-Oriented Support
In vitro strategies aligned with current expectations for comparative, discriminating, and product-specific studies.
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Regulatory-Focused Strategy
Study designs aligned with global development and submission needs.
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Broad Dosage Form Coverage
Support across oral, topical, transdermal, nasal, inhalation, injectable, and nanomedicine products.
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Strong Application Fit
Support for formulation screening, reference comparison, biowaiver planning, bridging, and submission packages.
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Decision-Ready Data
Data that helps reduce development risk and accelerate program decisions.
How We Work
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1Project assessment
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2Study strategy and method selection
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3Comparative in vitro study execution
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4Data interpretation and reporting
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5Submission support as needed
FAQ
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Why do nasal spray and inhalation products require multiple in vitro tests?
OINDPs require multi-attribute evaluation, including dose delivery, spray characteristics, and aerodynamic performance, to support IVBE and comparative assessment.
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Why are discriminating in vitro methods important for complex products?
They help identify meaningful formulation and performance differences before pivotal studies or submission.
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How can in vitro studies support biowaiver strategies?
Comparative dissolution, permeability, and formulation characterization can support biowaiver planning, bridging strategies, and early development decisions.
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What is the role of IVRT and IVPT in topical in vitro bioequivalence?
IVRT compares release from semisolid formulations, while IVPT evaluates skin permeation and provides stronger comparative evidence for certain topical products.
Discuss My Project
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