The US Food and Drug Administration (FDA) is currently developing a guidance for industry to replace a previous guidance, "Pharmacokinetics in Patients With Impaired Renal Function--Study Design, Data Analysis, and Impact on Dosing and Labeling" (renal guidance) issued in May 1998. The impact of the 1998 renal guidance was assessed following a survey of 94 new drug applications (NDAs) for small-molecule new molecular entities (NMEs) approved over the past 5 years (2003-2007). The survey results indicate that 57% of these NDAs included renal impairment study data, that 44% of those with renal data included evaluation in patients on hemodialysis, and that 41% of those with renal data resulted in recommendation of dose adjustment in renal impairment. In addition, the survey results provided evidence that renal impairment can affect the pharmacokinetics of drugs that are predominantly eliminated by nonrenal processes such as metabolism and/or active transport. The latter finding supports our updated recommendation to evaluate pharmacokinetic/pharmacodynamic alterations in renal impairment for those drugs that are mainly eliminated by nonrenal processes, in addition to those that are mainly excreted unchanged by the kidney.

Background and Objectives The ISBT Working Party on Blood Supply Management undertook an international survey of blood component wastage rates. Materials and Methods Using a survey website, questions were developed and validated to collect information on component wastage rates and the mechanisms for this wastage at hospital transfusion services around the world. Wastage was calculated as a percentage of the units issued (WAPI), which accounts only for the issued products not the size of the blood bank's inventory. Results There were 85 useable responses over an approximately 6‐month period. The majority of respondents were from Europe (53/85, 62%) and North America (19/85, 22%). The rest were from Oceania, Asia and the Middle East. Most respondents were from major academic teaching hospitals (45/85, 53%) with >1000 beds (32/85, 38%). There was no significant difference in the median regional WAPI wastage rates for RBCs and platelets between Europe (1·6%, 3·3%), North America (1·3%, 2·9%) and the rest of the world (2·4%, 7·2%) (P > 0·05 for all comparisons). Plasma wastage rates were also not different between these 3 regions. Neither RBC shelf life (≤35 days vs. 42 days) nor platelet shelf life (5 days vs 7 days) significantly affected the rate of product expiration in the hospital blood bank. Conclusion The median wastage rates are low around the world; a more detailed understanding of the specific mechanisms that lead to wastage around the world will help further reduce the rate.

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