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Pharmaceutical Alternatives: Polymorphic Form-Related and Particle Size-Related Therapeutic Nonequivalence

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Changes in polymorphic forms can significantly influence the bioavailability of poorly soluble drugs. Although the FDA defines pharmaceutical equivalence based on having the same active ingredient, dosage form, and route of administration, it does not automatically disqualify products with different polymorphic forms. This means two products with different polymorphs can still be deemed pharmaceutically equivalent. However, polymorphic differences can affect properties like wettability,...

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Related Experiment Video

Updated: Jul 7, 2026

Dissolving Microneedle Array Patches Manufactured By Solvent Casting Technique and Essential Characterization of Microneedle-Based Biomedical Devices

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Published on: January 30, 2026

Addressing Challenges, Regulatory Shifts, and the Need for Cost-Effective Alternatives for Complex Topical

Amatha Sreedevi¹, S Smitha Prabhu², Virendra S Ligade¹

¹Department of Pharmaceutical Regulatory Affairs and Management, Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education, Manipal, 576104, Karnataka State, India.

Current Pharmaceutical Design

|July 6, 2026

Summary

Developing generic topical medicines faces challenges in proving bioequivalence (BE). This review highlights in vitro methods and microstructural analysis for regulatory approval, aiming for cost-effective treatments.

Keywords:

Bioequivalence challenges regulations sameness topical formulation

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Last Updated: Jul 7, 2026

Dissolving Microneedle Array Patches Manufactured By Solvent Casting Technique and Essential Characterization of Microneedle-Based Biomedical Devices

Dissolving Microneedle Array Patches Manufactured By Solvent Casting Technique and Essential Characterization of Microneedle-Based Biomedical Devices

Published on: January 30, 2026

Targeted Plasma Membrane Delivery of a Hydrophobic Cargo Encapsulated in a Liquid Crystal Nanoparticle Carrier

Targeted Plasma Membrane Delivery of a Hydrophobic Cargo Encapsulated in a Liquid Crystal Nanoparticle Carrier

Published on: February 8, 2017

Area of Science:

Pharmaceutical Sciences
Dermatology
Regulatory Science

Background:

Topical dosage forms are crucial for skin disorders but face high costs due to limited generic options.
Developing generic topical products presents significant scientific and regulatory hurdles, particularly in demonstrating bioequivalence (BE).

Purpose of the Study:

To review current scientific and regulatory strategies for assessing the BE of topical generics.
To emphasize the role of in vitro alternatives and microstructural characterization (Q3) in overcoming development challenges.

Main Methods:

Narrative review of contemporary scientific and regulatory approaches for BE assessment.
Focus on in vitro methods (e.g., IVRT, IVPT) and dermal physiologically-based pharmacokinetic (PBPK) modeling.
Integration of Quality by Design (QbD) principles for robust BE strategies.

Main Results:

In vitro tools and Q3 microstructural characterization are emerging as key for regulatory acceptance.
Case studies demonstrate practical challenges and the growing adoption of in vitro and Q3-based approaches.
Identified critical gaps in harmonizing global regulatory requirements for topical generics.

Conclusions:

Standardizing methodologies and fostering early regulatory engagement are essential for a predictable and scientifically sound environment.
Adoption of advanced in vitro and Q3 approaches can reduce development timelines and improve access to topical generic medicines.
This transformation is vital for advancing the future of topical generic drug development and patient access.