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Category 1 Study Descriptions

A wide range of drug studies for precise data and reporting

Category 1 Study Descriptions

A wide range of drug studies for precise data and reporting

We conduct all our Category 1 (or studies under rigorous scientific, regulated and good laboratory practices (GLP), policies and procedures to ensure our data and results are reliable and reportable. Precise, comprehensive reporting is essential for a successful study, so we provide you with a complete dataset and quality-assured (QA’d) report. It includes a detailed description of the analytical methods we used along with observations and conclusions from each study we’ve conducted. This data may be used for your FDA regulatory filings. in vitro manipulation and extraction studies

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    API (active pharmaceutical ingredient) assay qualification / validation

    Using state-of-the-art instruments, DRUGSCAN first conducts robust assay validations designed to provide confidence in the analysis of active pharmaceutical ingredient (API) recoveries in all downstream experiments.

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    Physical manipulation

    The first step many drug abusers take is to manipulate the product’s dosage form using various tools—grinders, hammers, knives and others. They do this to reduce the tablet or capsule into a form that can be used via sniffing, injection, dose dumping with alcohol, smoking or purification of the API. We employ the techniques of both novice and experienced abusers.

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    Large-volume extraction

    Abusers also use readily available solvents to extract the API from the matrix materials of a drug. DRUGSCAN employs a variety of organic and inorganic solvents, in addition to various conditions and pretreatment methods, to assess the drug formulation’s resistance to extraction techniques.

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    Extracting the API in small amounts of solvents suitable for injection is a common and dangerous method of abuse. studies assess the ability to draw into and expel the drug out of syringes using various needle gauges. Our scientists also determine the API content in the volumes drawn and measure the viscosity down to <1ml.>

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    Heating a drug product to release and inhale the API is another common method of abuse. Using a proprietary apparatus that simulates smoking, which was developed by DRUGSCAN and Pinney Associates, our scientists are able to assess the amount of API released after heating and vaporization.

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    Abusers may try chewing a product to get a bigger high over a shorter period of time. Using our ERWEKA DRTTM chewing machine—one of only three in the world—we’re able to simulate chewing in vitro of tablet and other formulations, such as fentanyl transdermal patches, to determine the rates of API release at specific time intervals.

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    In vitro nasal insufflation

    We use this testing method to assess a formulation’s performance if it’s insufflated, or snorted, into the nose. This study could be conducted to understand the formulation’s probability of success before it’s entered into Category 2/3 intranasal in vivo studies.

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    API isolation and purification

    Sophisticated abusers use advanced methods to isolate and purify the API after it’s extracted. Our scientists use these same techniques to assess the difficulty and success of these methods.