Element’s pharmaceutical deformulation services are tailored to the needs of generic pharmaceutical companies, quickly delivering thorough and exacting Q1/Q2 sameness and Q3 similarity data for abbreviated new drug application (ANDA) submissions, reducing development timelines and accelerating speed to market.

Pharmaceutical reverse engineering has a wide variety of applications, ranging from generic drug development, product quality investigations, intellectual property dispute resolution, commercial product modifications for new markets, and to understand competitive formulations.

The FDA requires Q1 and Q2 sameness for certain types of drug products, and Q1/Q2 sameness may also be recommended in product-specific guidance (PSG) for generic development when in vitro methods for demonstrating bioequivalence (BE) are proposed. The ANDA regulatory pathway requirements for generic formulations detail specific inactive ingredient requirements for parenteral, ophthalmic, otic, and topical drug products, as well as permitted changes for such products. Qualitative and quantitative formulas, solid-state characteristics, and the manufacturing process must be equivalent to the reference listed drug (RLD) in order attain formulation sameness.

Demonstrating bioequivalence with IVRT & IVPT

Developing bioequivalent topical, otic and ophthalmic generic drug products is a complex process, and bioequivalence (BE) assessments can be completed with in-vitro release testing (IVRT) and in-vitro permeation testing (IVPT), per FDA and EMA regulatory guidance. IVRT studies demonstrate an equivalent rate of API release when the generic product is compared to the RLD. IVPT studies use Franz diffusion cells to measure the release rate and extent of API permeation through skin or a non-interactive synthetic membrane in both the test and reference product. With proven success in designing and executing bioequivalence studies for complex topical, otic, and ophthalmic products utilizing both IVRT and IVPT, Element’s teams of scientists deliver thorough IVRT and IVPT testing programs that address bioequivalence requirements of the ANDA regulatory pathway.

Q3 similarity assessments and solid-state characterization

For complex generic drug products, Q1/Q2 sameness may not provide sufficient data, and in those instances, Q3 physicochemical similarity must also be undertaken to diminish the risk associated with physicochemical differences between the generic and RLD, which may include rheology, particle size distribution, polymorphic form, and crystallinity. Q3 evaluation is of particular importance for ophthalmic suspension and topical products, as physicochemical properties influence product performance. Element’s consultative team of solid-state experts have a thorough understanding of solid-state characterization techniques and experience to help ANDA applicants meet Q3 similarity assessment requirements for complex drug products.

The Element advantage

Complex generic drug products face unique challenges throughout the drug development lifecycle, from Q1/Q2 (Q3) deformulation to characterization, formulation, and manufacturing. Element has a proven track record of success navigating complex dosage forms, routes of administration, APIs, and analytical challenges. Our laboratories are equipped with a comprehensive array of analytical instrumentation, tools, and techniques. Confidently navigate the ANDA filing and submission process with Element as your strategic CDMO partner.

To learn more about our pharmaceutical Q1/Q2 (Q3) deformulation and reverse engineering services, or to speak with one of our experts, contact us today.

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