SivaSanta Dialysis and Medical Clinic project gets nod
- See more at: http://www.themalaysianinsider.com/citynews/greater-kl/article/sivasanta-dialysis-and-medical-clinic-project-gets-nod#sthash.w68tvuB4.dpuf
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Tuesday, November 24, 2015
Monday, November 16, 2015
Diversifying the Global Heparin Supply Chain: Reintroduction of Bovine Heparin in the United States?
The global supply chain for bovine and porcine heparin and regulatory considerations are examined.
Nov 02, 2015
Pharmaceutical Technology
Volume 39, Issue 11
Courtesy of the US Pharmacopeial Convention.Heparin regulates hemostasis at various points of the coagulation cascade mainly through its interaction with antithrombin and heparin cofactor II. Because of these properties, heparin is a life-saving anticoagulant drug used in renal dialysis, cardiac surgery, and treatment for deep vein thrombosis. The drug also binds to platelets, inhibiting platelet function and contributing to the hemorrhagic effects of heparin. Bovine heparin, first approved in 1939, was widely used in the United States for more than 50 years (see Figure 1). Like all drugs, heparin can cause adverse effects, but overall, bovine heparin products were found to be safe and effective during that period.
Figure 1: Historical development timeline of therapeutic heparin in United States.[Courtesy of Authors]Read the full text hereMonday, July 20, 2015
Aseptic Processing: Keeping it Safe
Humans represent the greatest risk for microbial contamination in an aseptic process.
BioPharm International 1/7/2015
submitted by Dr Syed Ibrahim Ismail
Aseptic processing has garnered some increased scrutiny from FDA in recent years, primarily because it is considered a high-risk activity by the agency, says Rainer Newman, consultant at Aseptic Process Technology, LLC. In addition, says Satish Singh, research fellow and group leader at Pfizer, “Microbiologically-related recalls have always been a significant portion of the enforcement actions by FDA.” In fact, more than 75% of FDA recalls during 2004–2011 involved sterile products, and approximately 80% of these recalls were linked to “lack of sterility assurance.” Many of the remaining 20% of recalls were attributed to microbial contamination or a failed fill/finish product test (1). Although packaging failures factored into a majority of the “lack of sterility assurance” cases, many of the remaining contamination cases were associated with GMP issues or manufacturing errors such as incomplete sterilization or nonsterile components being added to sterile products (1).
Friday, January 23, 2015
Baxter’s Phoxillum Renal Replacement Solutions obtains FDA approval
Pharmaceutical Technology
http://www.pharmaceutical-technology.com/news/newsbaxter-phoxillum-renal-replacement-4493678?WT.mc_id=DN_News
Baxter International has received approval from US Food and Drug Administration (FDA) for its Phoxillum Renal Replacement Solutions (BK4/2.5 and B22K4/0) to use as replacement solutions in continuous renal replacement therapy (CRRT).
The therapy aims to correct electrolyte and acid-base imbalances.
In addition, Phoxillum can be used in case of drug poisoning when CRRT is used to remove dialysable substances.
Baxter vice-president and renal therapeutic area lead Bruce Culleto said: "The approval of Phoxillum allows us to offer healthcare providers additional options in managing critically ill acute kidney injury patients treated with CRRT.
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