IIVS | Pharmaceutical
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Pharmaceutical

Pharmaceutical companies can use in vitro testing for assessing worker safety. Pharmaceutical intermediates should be evaluated to determine the primary hazards associated with them so that those involved in the manufacturing process can take necessary precautions to avoid hazardous exposures.

Pharmaceutical compounds can vary widely in their physical forms, such as powders, liquids, and creams. Many in vitro assays such as those using 3-dimensional tissue constructs, and the Bovine Corneal Opacity and Permeability (BCOP) Assay, are suitable for testing different test article forms, and can provide predictions on the hazards associated with them. Testing can be structured by taking a tiered-testing approach depending on the expected irritation levels of the products, and using the protocol best suited for the test material. This could help to eliminate unnecessary testing. Protocols that align with OECD test guidelines for classification according to GHS hazards can be used, or companies may develop their own prediction models for internal safety assessment based on existing data for similar compounds (e.g. QSAR, in-vivo, or adverse outcome data).

Since there are multiple areas of concern for pharmaceutical products, several in vitro assays can be used to investigate potential hazards in areas such as ocular irritation, dermal irritation or corrosion, dermal sensitivity, cytotoxicity, phototoxicity and genotoxicity. Since test guidelines are available for many of these endpoints, hazard determination can be measured for submission to regulatory agencies.

In general, phototoxicty assays may be considered if the chemical absorbs light in the 290-900 nm range (covers UVB, UVA, visible light) and is directly applied to or accumulates on the skin or eyes. The 3T3 Neutral Red Uptake (NRU) Phototoxicity (OECD TG 432) assay is generally recommended as an initial screening for photosafety evaluations. The assay is described in U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) “Guidance for Industry: Photosafety Testing”, the European Medicines Agency (EMEA)’s “Note for Guidance on Photosafety Testing”, and the International Conference of Harmonization (ICH) Photosafety Evaluation of Pharmaceuticals S10 Document. The ICH S10 document also mentions that the reconstructed human epithelial models are potentially useful for photosafety testing for topically applied chemicals.

Assays of Interest