Excipient Usage Technical Risk Assessment for Generic Solid Dose Products

This paper proposes an assessment methodology for solid dose generic small molecule drug products. It addresses the ‘usage of the excipient’ portion of the trinomial by utilizing the systematic approach of Risk Identification, Risk Analysis and Risk Evaluation as per ICH Q9 Quality Risk Management outlined for developing risk control strategies. The assessment and maintenance of excipient risk profile is essential to minimize any potential risk associated to excipients impacting patients

Fetus in Fetu as a suprarenal mass in a neonate – a rare and perplexing entity

Fetus in fetu (FIF) is a rare entity in which a malformed vertebrate fetus is incorporated within its twin. This entity should be differentiated from a teratoma, which has more malignant potential. We describe a neonate with a heterogeneous calcified suprarenal mass. The aspiration cytology revealed a heterogeneous cell population with spindle cells and small round blue cells. Operative and histopathologic examination showed features consistent with a fetus in fetu. This case report describes a rare entity and discusses its clinical presentation, cytological features on fine-needle aspiration, and the difficulties posed in its differentiation from a teratoma

Drug-induced impairment of renal function

George Sunny Pazhayattil, Anushree C Shirali Section of Nephrology, Yale University School of Medicine, New Haven, CT, USA Abstract: Pharmaceutical agents provide diagnostic and therapeutic utility that are central to patient care. However, all agents also carry adverse drug effect profiles. While most of these are clinically insignificant, some drugs may cause unacceptable toxicity that impacts negatively on patient morbidity and mortality. Recognizing adverse effects is important for administering appropriate drug doses, instituting preventive strategies, and withdrawing the offending agent due to toxicity. In the present article, we will review those drugs that are associated with impaired renal function. By focusing on pharmaceutical agents that are currently in clinical practice, we will provide an overview of nephrotoxic drugs that a treating physician is most likely to encounter. In doing so, we will summarize risk factors for nephrotoxicity, describe clinical manifestations, and address preventive and treatment strategies. Keywords: acute kidney injury, chronic kidney disease, drug nephrotoxicity, chemotherapy, NSAID

Excipient Usage Technical Risk Assessment for Generic Solid Dose Products

This paper proposes an assessment methodology for solid dose generic small molecule drug products. It addresses the ‘usage of the excipient’ portion of the trinomial by utilizing the systematic approach of Risk Identification, Risk Analysis and Risk Evaluation as per ICH Q9 Quality Risk Management outlined for developing risk control strategies. The assessment and maintenance of excipient risk profile is essential to minimize any potential risk associated to excipients impacting patients

Mycobacterium neoaurum causing prosthetic valve endocarditis: a case report and review of the literature

Mycobacterium neoaurum is a rare cause of bacteremia, and infection usually occurs in an immunocompromised host in the setting of an indwelling catheter. Prosthetic valve endocarditis due to non-tuberculous mycobacteria typically carries a dismal prognosis; we report a case of M. neoaurum prosthetic valve endocarditis with favorable response to antimicrobial therapy without surgical intervention. Keywords: Mycobacterium neoaurum, Prosthetic valve, Endocarditi