The comparability assessment of a biological product after implementing a manufacturing process change should involve a risk-based approach. Process changes may occur at any stage of the product lifecycle: early development, clinical manufacture for pivotal trials, or post-approval. The risk of the change to impact product quality varies.
View Article and Find Full Text PDFObjectives: We sought to evaluate modern diagnostic and treatment options for urachal adenocarcinoma (UAC) and to provide clarity regarding the available options and their outcomes for this poorly understood yet damaging disease.
Material And Methods: We conducted a systematic literature search in PubMed and Medline focusing on updated management of UAC.
Results: Surgical intervention continues to be the mainstay of treatment for localized UAC.