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Preparation of Toxicology reports:

A toxicology test examines for traces of drugs in your blood, urine, hair, sweat, or saliva. The usual practice in toxicological analysis begins with the initial identification of alcohol and screening of acidic, neutral, and basic organic drugs or poisons. At Atop Pharma Solutions, our toxicology consultants have years of experience in conducting safety assessment, regulatory toxicology, mechanistic toxicology studies, etc. Our consultants will work as an extension of your team to help you expedite your analysis goals. Our consultants will help your association with safety pharmacology studies, whether you focus on the on-target, off-target, or cross-target compounds, we will provide exhaustive insights for early drug discovery and safety profiling. Our dedicated team of consultants will aid you with reviewing study protocols, interpreting scientific outcomes, and preparation of reports.

Calculation of PDE and NOAEL:

Over the years, Atop Pharma Solution’s toxicologists have developed and yielded high-quality PDE/NOAEL reports in adherence with the EMA, ISPE, ASTM, and other country-specific guidelines. We have developed PDE/NOAEL reports for oral, parenteral, inhalation, topical, and some of the unique ways, like, ophthalmic and otic. The PDE denotes a substance-specific dose that is improbable to cause an adverse effect if an individual is exposed at or below this dose daily. The no observed adverse effect level (NOAEL) is the highest dose where the effects are marked in the treated group do not indicate an adverse effect to the subject. The NOAEL also described determining the toxicity of a substance or material. We at Atop Pharma Solutions assist you to calculate PDE and NOAEL reports with our toxicologist’s help.

Cleaning Validation and MACO calculation:

The correct calculation of the cleaning validation limits from maximum allowable carryover (MACO) of a marker compound to the subsequent product is critical for the integrity and triumph of the cleaning validation. However, the process of generating those limits often affects error-prone manual calculations. At Atop Pharma Solutions, we represent a creative yet simple tool that uses software and a statistical platform to fully automate MACO calculations in pharmaceutical cleaning validation. A reliable cleaning validation program is important to GMP manufacturing and benefits allow a manufacturing unit to deliver quality products on time and in full to market. This program along with other quality programs such as process validation, corrective and preventive action (CAPA) has shown significant results.