Nanomedicine is an emerging field with continuous growth and differentiation. Liposomal formulations are a major platform in nanomedicine, with more than fifteen FDA-approved liposomal products in the market. However, as is the case for other types of nanoparticle-based delivery systems, liposomal formulations and manufacturing is intrinsically complex and associated with a set of dependent and independent variables, rendering experiential optimization a tedious process in general. Quality by design (QbD) is a powerful approach that can be applied in such complex systems to facilitate product development and ensure reproducible manufacturing processes, which are an essential pre-requisite for efficient and safe therapeutics. Input variables (related to materials, processes and experiment design) and the quality attributes for the final liposomal product should follow a systematic and planned experimental design to identify critical variables and optimal formulations/processes, where these elements are subjected to risk assessment. This review discusses the current practices that employ QbD in developing liposomal-based nano-pharmaceuticals.

Liver biopsy remains the gold standard for diagnosing liver pathology, yet its application during pregnancy is limited due to concerns for maternal and fetal safety. While percutaneous, image-guided techniques are generally safe, the risk of complications, though low, has led most providers to defer biopsy until postpartum. Nevertheless, timely evaluation of liver disease in pregnancy is crucial, given its potential impact on both maternal and fetal outcomes. This review examines the indications, outcomes, and safety of liver biopsy during pregnancy. Pregnancy-related liver disease presents unique diagnostic challenges. Conditions such as acute fatty liver of pregnancy (AFLP), intrahepatic cholestasis of pregnancy (ICP), HELLP (hemolysis, elevated liver enzymes, low platelet count) syndrome, hemophagocytic lymphohistiocytosis (HLH), and hepatic masses may warrant biopsy in select cases. Although diagnostic tools such as the Swansea criteria reduce the need for biopsy in AFLP, histological confirmation may be essential when non-invasive methods are inconclusive. In rare cases of hepatocellular carcinoma or suspected graft rejection post-liver transplant, biopsy may provide indispensable diagnostic clarity. However, evidence regarding its safety remains sparse. Overall, liver biopsy during pregnancy is rarely indicated but can be pivotal when non-invasive tests fail to establish a diagnosis. Current guidelines recommend a stepwise approach, prioritizing non-invasive modalities before proceeding to biopsy. Further prospective studies are needed to better define the safety profile and diagnostic yield of liver biopsy in this population.