RESUMEN
The vendor qualification assessment (VQA) process is regarded as expensive and time consuming but there is no quantitative data characterizing and benchmarking this process. The Tufts Center for the Study of Drug Development (Tufts CSDD)-in collaboration with the Avoca Group and 13 pharmaceutical, biotechnology and contract research organizations-conducted a survey of 120 unique companies to gather baseline data. The study results confirm that companies are investing substantial time and resources to support a high and growing volume of vendor qualifications and re-qualifications each year. The average total time to perform a vendor qualification is almost 5 months for single service providers and nearly 7 months for multi-service providers with wide variation within and between companies observed. Re-qualification cycle times are only marginally faster although, in theory, experience and familiarity with a given vendor should replace some assessment requirements. Significant differences were observed by company size and type. A high percentage of assessments-most notably those conducted by large companies-involve customized assessment areas. CROs are able to perform the VQA process significantly faster with fewer personnel. Based on the data provided, Tufts CSDD estimates that global drug developers spent about $375 million to perform approximately 25,000 new vendor qualifications and re-qualifications in 2018.
Asunto(s)
Benchmarking , Desarrollo de Medicamentos , Biotecnología , Encuestas y CuestionariosRESUMEN
Antihypertensive drugs can have different effects on central and brachial blood pressures, which may affect outcomes. Nitric oxide donors have acute effects on central blood pressure but have not been assessed with renin-angiotensin system blockade. Thirteen patients with prehypertensive/Stage 1 hypertension were randomized to five single-dose treatments separated by ≤4 days using a double-blind, crossover study design: angiotensin receptor blocker (ARB) losartan 100 mg, isosorbide mononitrate (ISMN) 60 mg, losartan 100 mg + ISMN 15 mg, losartan 100 mg + ISMN 60 mg, and placebo. Central and brachial blood pressures were measured throughout 10 hours. Mean placebo-subtracted decrease from baseline in augmentation index (AIx) approximately 1% for losartan 100 mg, 26% for ISMN 60 mg, 19% for losartan 100 mg + ISMN 15 mg, and 24% for losartan 100 mg + ISMN 60 mg. Administered with losartan 100 mg or alone, ISMN lowered AIx, demonstrating that acute effects of a nitrate donor are much larger than those of an ARB even when administered with an ARB. Differences from placebo were statistically significant except for losartan 100 mg. AIx is a good biomarker of acute hemodynamic effects of nitric oxide in prehypertensive/Stage 1 hypertension.