Analytical Quality by Design (AQbD)–Based Development and Validation of a Stability-Indicating HPLC Method for Pirfenidone

Pirfenidone, as compared with placebo, reduced disease progression, as reflected by lung function, exercise tolerance, and progression-free survival, in patients with idiopathic pulmonary fibrosis. Treatment was associated with an acceptable side-effect profile and fewer deaths.Idiopathic pulmonary fibrosis is a chronic, progressive, and fatal lung disease that is characterized by irreversible loss of lung function.1 Although periods of transient clinical stability may be observed, continued progression of the disease is inevitable.2 The prognosis is poor, with a 5-year survival rate that is similar to the rates for several cancers

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