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Category 1 Studies Expertise

DRUGSCAN offers you a unique combination of scientific skill and experience.

Category 1 Studies Expertise

DRUGSCAN offers you a unique combination of scientific skill and experience.

DRUGSCAN’s CAT.one laboratory has conducted studies on a wide variety of abuse-deterrent (AD) formulations and non-AD comparator formulations to satisfy Category 1 testing in the FDA’s guidance for innovator and generic formulations. We offer you a proven track record in successful in vitro (laboratory) manipulation and extraction studies, with principal scientists who are familiar with observing, understanding and summarizing a product’s abuse-deterrent drug performance in order to interpret and present each study’s scientific data. 

Category 1 drug testing is inherently variable and requires proper training and regular competency verifications. In addition, downstream statistical comparisons rely on structured and consistent data. Lab protocols and standard operating procedures (SOPs) evolve over time, so we consistently draw from our experience with other Category 1 programs for each step of each study. These studies fall into three categories:

Prototype selection studies

A limited set of experiments to evaluate a prototype’s performance relative to the reference listed drug (RLD).

Exploratory studies

Devised to identify the strengths and weaknesses of a formulation to inform the downstream study design.

Pivotal category 1 studies

Designed and conducted to provide sufficient data for regulatory review of the product.

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CAT.one analytical assays

Technologies for robust and rapid analysis

  • High-volume capabilities
  • LC-MS/MS, UV/VIS and CAD detection
  • Multi-component analysis of APIs and excipients (i.e. SLS and PEO)

Validation and quality control ensured

  • Testing and confirmation for stability of extracts
  • Extensive interference studies conducted
  • Use of excipients, Category 1 solvents and reagents
  • Specialized maintenance procedures to maintain instrument performance

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Choose DRUGSCAN for CAT.one studies

For more information about our capabilities, contact us today.

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