Baxter (India)

The New Product Development Process (NPDP) is a systematic approach to product development, consisting of various stages from ideation to commercialization. The Waterfall model and the Iterative (Agile) model are two commonly used approaches to product development, with each having its own strengths and weaknesses. The V-model is a sequential development process used in regulated industries, emphasizing the importance of verification and validation in product development. Although the V-model is well-suited for regulated industries, it can be inflexible and not adaptable to changes in requirements or feedback. Therefore, a more agile model is needed, with continuous testing and validation throughout the development process. In this paper we are Proposing the Zhivete model - a hybrid of V model and Agile Scrum for product development. Offers structured approach with flexibility and adaptation, potentially reducing time and cost. Keyowrds: New Product Development Process, Waterfall model, V-model, Iterative (Agile) model

[This corrects the article DOI: 10.1098/rsos.182237.].

Multifocal motor neuropathy (MMN) is a rare, purely motor neuropathy. It is a progressive disorder, most patients eventually developing severe fatigue and weakness in the arm muscles that severely impair daily functioning and quality of life. Unlike other motor neuropathies such as motor neurone disease, MMN is treatable with regular infusions of intravenous immunoglobulin (IVIg). Four double-blind, randomised, placebo-controlled studies have shown that in the short term, IVIg significantly improves muscle strength and disability in more than 70 % of patients. The 11 observational studies reviewed in this article confirm that long-term maintenance treatment with IVIg maintains clinical improvement compared to pre-treatment baseline in most patients. Infusions are generally well tolerated, but regular monitoring and re-evaluation of the IVIg maintenance regimen is essential, as most patients need progressive increases in dosage or reduced intervals between infusions to maintain their response to treatment. In the absence of accepted predictive markers, maintenance IVIg should be individualised, based on each patient’s initial response, disability and the interval between the first infusion and decline in muscle strength.

Little is known about survival on peritoneal dialysis (PD) in Indian patients since the initiation of continuous ambulatory PD (CAPD) in India in 1991. Survival data from single centers with small numbers have been published. A retrospective 4-center analysis for predictors of survival >3 years in south Indian chronic PD patients. A total of 309 patients were trained during the observation period (from 1999 to 2004) and were analyzed in a multicenter study (4 centers), including 150 patients (male:female 109:41) that survived > or = 3 years and 59 patients that did not survive > or = 3 years (nonsurvivors; male: female 43:16) that were taken as controls. The patients were on chronic PD, predominantly CAPD, using double-bag disconnect systems. They were supervised by 4 nephrologists. Mean age in the nonsurvival group was 56.6 +/- 10.6 years. In the survival group, mean age was 50.9 +/- 14.9 years; there were 92 (62%) nondiabetics and 58 (38%) diabetics; the majority were nonvegetarians; 148 patients were doing 6 - 8 L exchanges and 2 were doing >8 L exchanges daily; 93 of 102 patients were average transporters based on peritoneal equilibration testing. At the beginning, mean combined Kt/V was 2.31 and weekly creatinine clearance was 73 L. Patients making one lifetime payment were 46% and 21% belonged to the full reimbursement group. Body mass index (BMI) was normal in 114 patients (76%). Ultrafiltration volume was 1377 +/- 452 at the start and 1400 +/- 461 mL/day after 3 years. Anuric patients at the start were 12% and after 3 years 44%; urine output decreased from 527 +/- 26 to 253 +/- 14 mL/day from the start to after 3 years. Peritonitis rate was 1 episode/75 patient-months at the beginning and after 3 years it was 1 episode/30 patient-months. Exit-site care was done daily by 88% and 3 times weekly by 12%. Nonsmokers were 92% and smokers were 8%. Those that lived in the city were 62% and rural areas were 38%. Mean blood pressure was 143 +/- 16/88 +/- 10 and 136 +/- 18/85 +/- 9 mmHg, calcium x phosphorus product 44.6 +/- 15.6 and 45.9 +/- 15.7 mg(2)/dL(2), albumin 3.33 +/- 0.5 and 3.25 +/- 0.4 g/dL, hemoglobin 9.18 +/- 2 and 9.48 +/- 1.8 g/dL at the beginning and after 3 years, respectively. Statistical analysis showed a significant fall in both systolic (p < or = 0.001) and diastolic blood pressure (p < or = 0.05), an increase in BMI (p < or = 0.01), and a decrease in blood urea (p < or = 0.001) in the survival group. Those with Hb > or = 11 g/dL survived longer (p < or= 0.001), those with serum albumin > or = 3 g/dL had better survival (p = 0.001), and anuric patients survived longer (p = 0.001). This multicenter cohort study of prevalent continuous PD patients in south India showed nondiabetics, average transporters, nonsmokers with reasonable nutritional status, with Hb 11 g/dL, with low peritonitis rate, with over 1 L ultrafiltration volume per day, the great majority that joined the once per lifetime payment scheme, and the reimbursement group survived for 3 years or longer.

Pasadena, California First Baxter Lecture of the International Anesthesia Research Society *Contribution No. 3008, Gates and Crellin Laboratories of Chemistry, California Institute of Technology, Pasadena, California.