Pharmaceutical Division Research Articles

МЕТОДОЛОГІЯ ОПЛАТИ ПРАЦІ В ДЕРЖАВНИХ ЗАКЛАДАХ ОХОРОНИ ЗДОРОВ’Я

Досліджено основні аспекти організації обліку видатків на оплату праці в державних закладах охорони здоров’я на підставі діючого нормативно-правового забезпечення. Розглянуто організацію обліку видатків медичного закладу на основну, додаткову зарплату та інші компенсаційні, заохочувальні виплати в системі рахунків бюджетного обліку.

Radium-223 and concomitant therapies in patients with metastatic castration-resistant prostate cancer: an international, early access, open-label, single-arm phase 3b trial

In the previously reported ALSYMPCA trial in patients with castration-resistant prostate cancer and symptomatic bone metastases, overall survival was significantly longer in patients treated with radium-223 dichloride (radium-223) than in patients treated with placebo. In this study, we investigated safety and overall survival in radium-223 treated patients in an early access programme done after the ALSYMPCA study and before regulatory approval of radium-223. We did an international, prospective, interventional, open-label, single-arm, phase 3b study. Enrolled patients were aged 18 years or older with histologically or cytologically confirmed progressive bone-predominant metastatic castration-resistant prostate cancer with two or more skeletal metastases on imaging (with no restriction as to whether they were symptomatic or asymptomatic; without visceral disease but lymph node metastases were allowed). Patients received intravenous injections of radium-223, 50 kBq/kg (current recommendation 55 kBq/kg after implementation of National Institute of Standards and Technology update on April 18, 2016) every 4 weeks for up to six injections. Other concomitant anticancer therapies were allowed. Primary endpoints were safety and overall survival. The safety and efficacy analyses were done on all patients who received at least one dose of the study drug. The study has been completed, and we report the final analysis here. This study is registered with ClinicalTrials.gov, number NCT01618370, and the European Union Clinical Trials Register, EudraCT number 2012-000075-16. Between July 22, 2012, and Dec 19, 2013, 839 patients were enrolled from 113 sites in 14 countries. 696 patients received one or more doses of radium-223; 403 (58%) of these patients had all six planned injections. Any-grade treatment-emergent adverse events occurred in 523 (75%) of 696 patients; any-grade treatment-emergent adverse events deemed to be related to treatment were reported in 281 (40%) patients. The most common grade 3 or worse treatment-related treatment-emergent adverse events were anaemia in 32 (5%) patients, thrombocytopenia in 15 (2%) patients, neutropenia in ten (1%) patients, and leucopenia in nine (1%) patients. Any grade of serious adverse events were reported in 243 (35%) patients. Median follow-up was 7·5 months (IQR 5-11) and 210 deaths were reported; median overall survival was 16 months (95% CI 13-not available [NA]). In an exploratory analysis of overall survival with predefined factors, median overall survival was longer for: patients with baseline alkaline phosphatase concentration less than the upper limit of normal (ULN; median NA, 95% CI 16 months-NA) than for patients with an alkaline phosphatase concentration equal to or greater than the ULN (median 12 months, 11-15); patients with baseline haemoglobin levels 10 g/dL or greater (median 17 months, 14-NA) than for patients with haemoglobin levels less than 10 g/dL (median 10 months, 8-14); patients with a baseline Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 (median NA, 17 months-NA) than for patients with an ECOG PS of 1 (median 13 months, 11-NA) or an ECOG PS of 2 or more (median 7 months, 5-11); and for patients with no reported baseline pain (median NA, 16 months-NA) than for those with mild pain (median 14 months, 13-NA) or moderate-severe pain (median 11 months, 9-13). Median overall survival was also longer in patients who received radium-223 plus abiraterone, enzalutamide, or both (median NA, 95% CI 16 months-NA) than in those who did not receive these agents (median 13 months, 12-16), and in patients who received radium-223 plus denosumab (median NA, 15 months-NA) than in patients who received radium-223 without denosumab (median 13 months, 12-NA). Our findings show that radium-223 can be safely combined with abiraterone or enzalutamide, which are now both part of the standard of care for patients with metastatic castration-resistant prostate cancer. Furthermore, our findings extend to patients who were asymptomatic at baseline, unlike those enrolled in the pivotal ALSYMPCA study. The findings of prolonged survival in patients treated with concomitant abiraterone, enzalutamide, or denosumab require confirmation in prospective randomised trials. Pharmaceutical Division of Bayer.

The Cobas ® EGFR Mutation Test v2 Assay

Paul Brown speaks to Gemma Westcott, Commissioning Editor: Paul Brown has served as the Head of Roche Molecular Diagnostics at Roche Diagnostics Corporation since February 2010 having previously held a variety of positions within Roche Pharma. After completing his doctorate in organic chemistry he was awarded a post-doctoral fellowship at the California Institute of Technology in Pasadena, CA, USA, but soon returned to his native UK to join Roche Pharma Research. Paul's first post within Roche was as group leader, doing drug discovery and making new small molecule drugs, but later moved into the business part of the company. Since then, he has enjoyed roles such as lifecycle leader for brands such as Tamiflu(®) and Xenical, vice president of sales and marketing of the pharmaceutical division and most recently general manager of Roche Pharma, Sweden.

Safety and efficacy of health supplement for weight loss

Purpose: The aim of this review is to evaluate the safety and efficacy of a product named acai berry ABC and to understand the marketing issues implemented by this product. Methodology: A review regarding registration of product was conducted by examining the registration in Pharmaceutical Division Services, Ministry of Health of Malaysia and the profile of product was evaluated by assessing the online MIMS. Besides that, an electronic search was conducted through searching at Cochrane Library, EMBASE, PubMed to assess the safety and efficacy of the product. Malaysia Advertisement Board was referred to evaluate the marketing issue in acai berry ABC. Results: According to Pharmaceutical Division Services, Ministry of Health, acai berry ABC is listed under product adulterated with poison which is contained sibutramine as an active ingredient which is against the Sale of Drugs Act 1952. Acai berry ABC widely advertised throughout social media such as Facebook, website services, and online marketing. Thus, there are a few issues related to marketing that against the Medicine Advertisement Board. Moreover, a review on safety and efficacy of sibutramine reported that sibutramine is effective in weight loss and it also may increase slightly in blood pressure (BP). Sibutramine should be used cautiously in patients with borderline or high BP. However, the Sibutramine Cardiovascular Outcome Trial (SCOUT) trial showed that long-term use of sibutramine among the subject with cardiovascular disease had a risk of nonfatal myocardial infarction and nonfatal stroke, but not of cardiovascular death or death from any cause. Due to SCOUT trial, physician and pharmacist are recommended by the European Medicine Agency have to stop selling products containing sibutramine. Malaysia also banned this product since 2010. However, still there is a company selling the herbal weight loss product adulterated with sibutramine such as acai berry ABC. Conclusions: Ministry of Health has banned the selling of acai berry ABC in Malaysia due to adulteration with sibutramine which may risk and harmful to cardiovascular disease patient. As for Malaysian, it is not safe to consume the product that contains with control poison without consultation from physician or pharmacist. It is a pharmacist responsibility to educate people to consume an only product that registered with Ministry of Health. Malaysian should always consult with a physician or pharmacist if any confusion regarding any product that they have been consumed.

Evidence of Garcinia cambogia as a fat burning and appetite suppressing agents

Aim: The aim of this study is to assess the uses of products containing Garcinia cambogia to burn fat and suppressed the appetite. Introduction: The availability and popularity of natural dietary supplements for the treatment of obesity have risen dramatically in recent years. Investigation and analysis on the efficacy and effectiveness of the G. cambogia are challenging. Furthermore, consuming the products that claimed the anti-obesity effect without a strong judgment is not an appropriate way to losing weight. The overweight prevalence of 29.71% for the Malaysian adults aged 18–59 years indicates that the overweight problem in Malaysia is almost as serious as that for the developed countries. Methodology: An electronic search of PubMed, CINAHL, ScienceDirect, Clinical Key for studies, case report, trials and reviews using the following search criteria. Examining the product registration in Pharmaceutical Division Services, Ministry of Health. The Malaysian Advertisement Board was referred. Results: Consumers in Malaysia most likely tend to have a fast method in losing the weight. When the product is advertised inappropriately without any strong evidence based, the Malaysian society is solely at risk in buying the product that does not have a confirmed effectiveness and efficacy. The doubts in using G. cambogia are because the marketed product is there is no single formulation that contains only G. Cambogia.

Obituaries: David Gibson

David T. Gibson, Professor Emeritus of Microbiology at the University of Iowa, passed away on 24 July 2014 at the age of 76. Dave was a beloved husband, father, and grandfather, a gifted scientist, teacher and lecturer, and a dear friend to so many. Gibson was born in Wakefield in 1938, and spent his early years in Redcar, on the northeast coast of Yorkshire. He emigrated with his wife Janet to the United States in 1964 after receiving his B.Sc. and Ph.D. degrees in biochemistry at The University of Leeds. In 1967, after postdoctoral studies with Charles Sih at the University of Wisconsin and Reino Kallio at the University of Illinois, he joined the faculty of the Department of Microbiology at The University of Texas at Austin. The following year he returned to England and was employed as a research scientist at the Pharmaceuticals Division of Imperial Chemical Industries. In 1969 he returned to The University of Texas, eventually rising to the positions of Professor and Director of The Center for Applied Microbiology. In 1988 he moved to The University of Iowa to take the first endowed Edwin B. Green Chair in Biocatalysis and Microbiology, a position he held until his retirement in 2004.

Targeting the American market for medicines, ca. 1950s-1970s: ICI and Rhône-Poulenc compared.

The forces that have shaped American medicine include a wide set of interrelated changes, among them the changing research, development, and marketing practices of the pharmaceutical industry. This article compares the research and development (R&D) and marketing strategies of the British group Imperial Chemical Industries (ICI, whose Pharmaceutical Division was spun off and merged with the Swedish company Astra to form AstraZeneca) and its French counterpart Rhône-Poulenc (now part of Sanofi-Aventis) in dealing with the American medical market. It examines how, in the process, the relationship between R&D and marketing was altered, and the firms themselves were transformed. The article also questions the extent to which their approaches to this market, one of the most significant markets for drugs in general, and for anticancer drugs in particular, became standardized in the period of "scientific marketing."

Stabilizing Biotechnology of Double Matrix Capsule Containing Lactobacillus Bacteria in Healthy Food Industry

This study is to develop the double matrix capsulation biotechnology in order to increase the conservativeness and stability of lactobacillus bacteria, to be deliciously flavored and give it visually differential effect in healthy food industries, were described. In order to eat easy for wellbeing life science, as the first capsulation with o/w (oil-in-water) emulsifying system, our study group was especially made to soft and moisture cream using 5wt% of sucrose ester emulsifier as the first capsule containing lactobacillus bacteria. Nutrient agents were used with botanical squalane, camellia japonica seed oil. Double matrix capsulation was formed with the best stabilized bead type capsules when it blended 1 : 3 ratio of chitosan and sodium alginate. The bead diameter size was about 2.0~5.0mm (mean diameter: 3.8mm). Activity of lactobacillus bacteria containing sweet cream for depending on various pH variations showed that alkalinity (pH=10.80.8) condition was higher than acidity (pH=4.20.3) and neutrality (pH=7130.2) conditions. After a month, it also was certified to the activity of lactobacillus bacteria in incubated at 373C in culture medium. As application of food industry, we developed the containing lactobacillus bacteria capsule and 4 colored kinds of double matrix capsulation in commercial yogurt cream. As for above mentioned those of results, one of tool to stabilize the living lactobacillus bacteria, doubled matrix capsulation greatly be expected to contribute to food industry. Furthermore, it can be expected to apply the drug delivery system (DDS) having good healthy food with active ingredients of stabilizing technologies at drugs, pharmaceutical divisions and skin care cosmetic industry.

Supply Chain Scenario Modeler: A Holistic Executive Decision Support Solution

McKesson is America’s oldest and largest healthcare services company. IBM Research developed an innovative scenario modeling and analysis tool, supply chain scenario modeler (SCSM), for McKesson to optimize its end-to-end pharmaceutical supply chain policies. Through integrated operations research (OR) models, SCSM optimizes the distribution network, supply flow, inventory, and transportation policies, and quantifies the impacts of changes on financial, operational, and environmental metrics. The modeling work spawned a roadmap of projects with quantified opportunities, including a new air freight supply chain path, and provided new insights that have been critical to improving McKesson’s performance as a pharmaceutical industry leader. A structured data model supporting the OR models has provided a basis for additional improvement projects. The model directly links OR modeling results to a detailed profit-and-loss statement by product category for the different supply chain paths that McKesson uses. Since this effort began in 2009, McKesson Pharmaceutical division has reduced its committed capital by more than $1 billion.

Dermatology: New approvals, investigational agents helping patients

Interventions aimed at improving dermatologic conditions have been a hot area of research in recent months. FDA has approved novel agents for the management of metastatic basal cell carcinoma and actinic keratosis, and researchers have focused on the use of alternative therapies, off-label use of FDA-approved agents, and on the efficacy and safety of investigational agents for management of select dermatologic conditions.

Industry Update: the Latest Developments in Therapeutic Delivery

The time period 6 October 2011 to 5 November 2011 was characterized by a number of major company announcements. Abbott Laboratories, a company that has long prided itself on its diversity, will split into two. The part that will retain the Abbott name will continue this tradition of diversity and the strategy of double-digit growth in earnings per share, albeit, without the pharmaceutical and biopharmaceutical research-based business. This will be spun out as another, yet to be named, publicly traded company. One firm’s strategic refocusing can, of course, facilitate another’s strategic development. This is certainly the case in the recent sale by SurModics of its pharmaceutical division to Evonik, where the former’s decision to concentrate on its device and in vitro diagnostic business opened up an opportunity for the latter to acquire additional formulation, polymer development and manufacturing expertise. Another example of this was Arrowhead’s purchase of Roche’s siRNA assets after the Swiss company decided to exit the field. As ever, the article is mainly sourced from company press releases and websites.

6,8-Di-t-butyl-4-oxo-4H-1-benzopyran-2-carboxylic acid: a chromone derivative with anti-allergic, anti-inflammatory and uricosuric activity

Journal Article 6,8-Di-t-butyl-4-oxo-4H-1-benzopyran-2-carboxylic acid: a chromone derivative with anti-allergic, anti-inflammatory and uricosuric activity Get access J Augstein, J Augstein Medicinal Chemistry Department, Research and Development Laboratories, Fisons Ltd., Pharmaceutical Division, Bakewell Road, Loughborough, Leics. LC11 0CY, U.K. Search for other works by this author on: Oxford Academic Google Scholar H Cairns, H Cairns Medicinal Chemistry Department, Research and Development Laboratories, Fisons Ltd., Pharmaceutical Division, Bakewell Road, Loughborough, Leics. LC11 0CY, U.K. Correspondence: Medicinal Chemistry Department, Research and Development Laboratories, Fisons Ltd., Pharmaceutical Division, Bakewell Road, Loughborough, Leics. LC11 0CY, U.K. Search for other works by this author on: Oxford Academic Google Scholar A Chambers, A Chambers Medicinal Chemistry Department, Research and Development Laboratories, Fisons Ltd., Pharmaceutical Division, Bakewell Road, Loughborough, Leics. LC11 0CY, U.K. Search for other works by this author on: Oxford Academic Google Scholar J W Burns, J W Burns Pharmacology Department, Research and Development Laboratories, Fisons Ltd., Pharmaceutical Division, Bakewell Road, Loughborough, Leics. LC11 0CY, U.K. Search for other works by this author on: Oxford Academic Google Scholar H Radziwonik H Radziwonik Pharmacology Department, Research and Development Laboratories, Fisons Ltd., Pharmaceutical Division, Bakewell Road, Loughborough, Leics. LC11 0CY, U.K. Search for other works by this author on: Oxford Academic Google Scholar Journal of Pharmacy and Pharmacology, Volume 28, Issue 12, December 1976, Pages 919–920, https://doi.org/10.1111/j.2042-7158.1976.tb04092.x Published: 12 April 2011 Article history Received: 17 June 1976 Published: 12 April 2011

A preliminary evaluation of a mercury intrusion method for assessing film continuity on coated tablets

Journal Article A preliminary evaluation of a mercury intrusion method for assessing film continuity on coated tablets Get access R C Rowe, R C Rowe I.C.I. Pharmaceuticals Division, Alderley Park, Cheshire, UK Search for other works by this author on: Oxford Academic Google Scholar S F Forse S F Forse I.C.I. Pharmaceuticals Division, Alderley Park, Cheshire, UK Search for other works by this author on: Oxford Academic Google Scholar Journal of Pharmacy and Pharmacology, Volume 26, Issue Supplement_1, December 1974, Pages 61P–62P, https://doi.org/10.1111/j.2042-7158.1974.tb10083.x Published: 12 April 2011

Aspirin dissolution: polymorphism, crystal habit or crystal defects.

Journal Article Aspirin dissolution: polymorphism, crystal habit or crystal defects Get access A G Mitchell, A G Mitchell Faculty of Pharmaceutical Sciences, University of British Columbia, B.C., Canada Search for other works by this author on: Oxford Academic Google Scholar Barbara L Milaire, Barbara L Milaire Faculty of Pharmaceutical Sciences, University of British Columbia, B.C., Canada Search for other works by this author on: Oxford Academic Google Scholar Dorothy J Saville, Dorothy J Saville Pharmacy Department, University of Sydney, N.S.W., Australia Search for other works by this author on: Oxford Academic Google Scholar R V Griffiths R V Griffiths I.C.I. Ltd. Pharmaceutical Division, Macclesfield, UK Search for other works by this author on: Oxford Academic Google Scholar Journal of Pharmacy and Pharmacology, Volume 23, Issue 7, July 1971, Pages 534–535, https://doi.org/10.1111/j.2042-7158.1971.tb08703.x Published: 12 April 2011

The orientation and alignment of particles in tablet film coatings.

Journal Article The orientation and alignment of particles in tablet film coatings Get access R C Rowe R C Rowe I.C.I. Pharmaceuticals Division, Alderley Park, Macclesfield, Cheshire, SK10 2TG. U.K. Search for other works by this author on: Oxford Academic Google Scholar Journal of Pharmacy and Pharmacology, Volume 35, Issue 1, January 1983, Pages 43–44, https://doi.org/10.1111/j.2042-7158.1983.tb04261.x Published: 12 April 2011 Article history Received: 13 July 1982 Published: 12 April 2011

Effect of clonidine on cardiac acceleration in pithed rats.

Journal Article Effect of clonidine on cardiac acceleration in pithed rats Get access J C Doxey J C Doxey Reckitt and Colman, Pharmaceutical Division, Dansom Lane, Hull, HU8 7DS, UK Search for other works by this author on: Oxford Academic Google Scholar Journal of Pharmacy and Pharmacology, Volume 29, Issue 1, September 1977, Pages 173–174, https://doi.org/10.1111/j.2042-7158.1977.tb11277.x Published: 12 April 2011 Article history Received: 31 August 1976 Published: 12 April 2011

A reappraisal of the equations used to predict the internal stresses in film coatings applied to tablet substrates.

Journal Article A reappraisal of the equations used to predict the internal stresses in film coatings applied to tablet substrates Get access R C Rowe R C Rowe I.C.I. Pharmaceuticals Division, Alderley Park, Macclesfield, Cheshire, SK10 2TG, U.K. Search for other works by this author on: Oxford Academic Google Scholar Journal of Pharmacy and Pharmacology, Volume 35, Issue 2, February 1983, Pages 112–113, https://doi.org/10.1111/j.2042-7158.1983.tb04280.x Published: 12 April 2011 Article history Received: 03 August 1982 Published: 12 April 2011

Variation in hydroxytryptamine metabolism in the rat: effects on the neurochemical response to phencyclidine.

Journal Article Variation in hydroxytryptamine metabolism in the rat: effects on the neurochemical response to phencyclidine Get access Sally R Tonge, Sally R Tonge School of Pharmacy, Liverpool Polytechnic, Byrom Street, Liverpool, UK Search for other works by this author on: Oxford Academic Google Scholar B E Leonard B E Leonard Pharmacology Section, ICI Ltd., Pharmaceuticals Division, Alderley Park, Macclesfield, Cheshire, UK Search for other works by this author on: Oxford Academic Google Scholar Journal of Pharmacy and Pharmacology, Volume 23, Issue 9, September 1971, Pages 711–712, https://doi.org/10.1111/j.2042-7158.1971.tb08752.x Published: 12 April 2011

The adhesion of film coatings to tablet surfaces-measurement on biconvex tablets.

Journal Article The adhesion of film coatings to tablet surfaces-measurement on biconvex tablets Get access R C Rowe R C Rowe ICI Pharmaceuticals Division, Alderley Park, Cheshire, UK Search for other works by this author on: Oxford Academic Google Scholar Journal of Pharmacy and Pharmacology, Volume 29, Issue 1, September 1977, Pages 58–59, https://doi.org/10.1111/j.2042-7158.1977.tb11244.x Published: 12 April 2011 Article history Received: 26 August 1976 Published: 12 April 2011

Taurine conjugation of fenclofenac in the dog.

Journal Article Taurine conjugation of fenclofenac in the dog Get access Bernard J Jordan, Bernard J Jordan Drug Metabolism Unit, Reckitt and Colman Pharmaceutical Division, Dansom Lane, Hull, UK Search for other works by this author on: Oxford Academic Google Scholar Michael J Rance Michael J Rance Drug Metabolism Unit, Reckitt and Colman Pharmaceutical Division, Dansom Lane, Hull, UK Search for other works by this author on: Oxford Academic Google Scholar Journal of Pharmacy and Pharmacology, Volume 26, Issue 5, May 1974, Pages 359–361, https://doi.org/10.1111/j.2042-7158.1974.tb09290.x Published: 12 April 2011 Article history Received: 05 January 1974 Published: 12 April 2011