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Potential exceptions exist when the prescriber can show a patient has a medical need for a formulation significantly different from the commercial product, for example, an allergy to an inactive ingredient in the approved drug

Frontiers in Endocrinology, 15, Article 1448394

Depending on the phenotype of the T helper cell that responds to the sequence, the immune response to a peptide impurity may be promoted (in the case of Tfh recognition) or suppressed (in the case of Tfr recognition)