Long-acting injectable (LAI) drug products enable the controlled release of a drug over an extended duration of time to improve the therapeutic effect, safety profile, or administration of an injectable product. The development of generic [505(j)] and differentiated [505(b)(2)] LAI products helps to provide patients and healthcare providers with more treatment options and to reduce overall healthcare costs, including those associated with drug product administration and patient compliance. In this review, we analyze the landscape of LAI products and identify the most common technical challenges that potential generic product entrants face.
View Article and Find Full Text PDFTerminally differentiated cells are defined by their inability to proliferate. When forced to re-enter the cell cycle, they generally cannot undergo long-term replication. Our previous work with myotubes has shown that these cells fail to proliferate because of their intrinsic inability to complete DNA replication.
View Article and Find Full Text PDFIntroduction: The colostomy is often necessary in complicated divertcular disease. The laparoscopic colostomy is not widely used for the treatment of complicated diverticular disease. Its use in patients with high operative risk is still on debate.
View Article and Find Full Text PDFBackground: Liver represents the main organ subject to metastases from colorectal tumors. Resections of liver metastases from colorectal cancer have a well-considered therapeutic role underlined by survival of 5 years by approximately 50-60% of surgical cases as is deduced from an analysis of the most recent literature. The objective of surgery is to eradicate the metastases present and obtain a margin free from neoplastic impact of amplitude of approximately 1 cm with residual liver quantity at the end of the intervention that allows the patient to survive.
View Article and Find Full Text PDFWe report the successful removal of an intraduodenal foreign body (f.b.) by endo-laparoscopic rendezvous, in a 67-year-old patient with mental disorders and duodenal occlusion by a large peach seed impacted in the duodenum.
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