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Keywords = indirect drug development costs

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14 pages, 310 KB  
Article
Direct and Indirect Costs of Prostate Cancer: A Comprehensive Assessment of Economic and Social Impact
by Izabela Gąska, Aleksandra Czerw, Monika Pajewska, Olga Partyka, Andrzej Deptała, Anna Badowska-Kozakiewicz, Natalia Czerw, Dominika Mękal, Katarzyna Sygit, Katarzyna Wojtyła-Blicharska, Jarosław Drobnik, Piotr Pobrotyn, Dorota Waśko-Czopnik, Adam Wiatkowski, Michał Marczak, Tomasz Czapla, Ewa Bandurska, Weronika Ciećko, Elżbieta Grochans, Anna M. Cybulska, Daria Schneider-Matyka, Kamila Rachubińska and Remigiusz Kozlowskiadd Show full author list remove Hide full author list
Cancers 2025, 17(19), 3257; https://doi.org/10.3390/cancers17193257 - 8 Oct 2025
Cited by 1 | Viewed by 1980
Abstract
Background: Prostate cancer is the second most common malignant cancer among men, and according to the predictions, the estimated number of new cases will substantially grow in the coming years. Therefore, the costs of the disease will increase as well. Methods: We conducted [...] Read more.
Background: Prostate cancer is the second most common malignant cancer among men, and according to the predictions, the estimated number of new cases will substantially grow in the coming years. Therefore, the costs of the disease will increase as well. Methods: We conducted a literature review of the state of knowledge about the costs of treatment and the economic burden of prostate cancer. The vast majority of studies were focused on direct costs only, which clearly shows the literature gap. Results: We focused on the estimates of direct costs, i.e., treatment of prostate cancer, adjuvant and neoadjuvant treatment, and supportive and palliative care, and indirect costs. Cost-effectiveness analyses indicated that docetaxel combined with androgen deprivation therapy (ADT) was the most cost-effective strategy for metastatic hormone-sensitive prostate cancer (incremental cost-effectiveness ratio (ICER): USD 13,647). In contrast, novel therapies such as PARP inhibitors and whole-genome-sequencing-guided treatments were not cost-effective unless drug prices were reduced by 47–70%. In the United States, 5-year cumulative treatment costs ranged from USD 48,000 for conservative management to over USD 91,000 for radiotherapy, while out-of-pocket expenses averaged AUD 1172 in Australia. Indirect costs were also considerable, with Slovakia reporting an increase in sick leave costs from EUR 1.2 million in 2014 to EUR 2.1 million in 2022. Conclusions: Metastatic hormone-sensitive prostate cancer and metastatic castration-resistant prostate cancer were the most frequent categories for various treatment cost evaluations. A few specific combinations of drugs were cost-effective only under the condition of dropping the unit prices of a medication. Further summarizing, reviewing, and developing a methodology for standardized comparisons are needed. Full article
(This article belongs to the Special Issue Cost-Effectiveness Studies in Cancers)
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26 pages, 1575 KB  
Review
Personalized Nutrition Strategies for Patients in the Intensive Care Unit: A Narrative Review on the Future of Critical Care Nutrition
by Mircea Stoian, Adina Andone, Sergiu Rareș Bândilă, Danusia Onișor, Dragoș-Florin Babă, Raluca Niculescu, Adina Stoian and Leonard Azamfirei
Nutrients 2025, 17(10), 1659; https://doi.org/10.3390/nu17101659 - 13 May 2025
Cited by 10 | Viewed by 8569
Abstract
Introduction: Critically ill patients in intensive care units (ICUs) are at high risk of malnutrition, which can result in muscle atrophy, polyneuropathy, increased mortality, or prolonged hospitalizations with complications and higher costs during the recovery period. They often develop ICU-acquired weakness, exacerbated by [...] Read more.
Introduction: Critically ill patients in intensive care units (ICUs) are at high risk of malnutrition, which can result in muscle atrophy, polyneuropathy, increased mortality, or prolonged hospitalizations with complications and higher costs during the recovery period. They often develop ICU-acquired weakness, exacerbated by sepsis, immobilization, and drug treatments, leading to rapid muscle mass loss and long-term complications. Studies indicate that adequate protein and calorie intake can decrease mortality and improve prognosis and recovery. However, optimal implementation remains a critical challenge. Objectives: This narrative review aims to summarize recent advances in nutritional strategies for critically ill patients. It highlights the benefits and limitations of current approaches including enteral (EN) and parenteral nutrition (PN) and examines their impact on clinical outcomes and overall mortality. Additionally, the review explores the emerging role of precision nutrition in critical care using technologies such as metabolomics and artificial intelligence (AI) to provide valuable insights into optimizing nutritional care in critically ill patients. Methods: A comprehensive literature search was conducted to identify recent studies, clinical guidelines, and expert consensus papers on nutritional support for ICU patients. The investigation focused on critical aspects such as the optimal timing for intervention, the route of administration, specific protein and energy targets, and technological innovations to support personalized nutrition, ensuring that each patient receives tailored support based on their unique needs. Results: Guidelines recommend initiating EN or PN nutrition within the first 48 h of admission, using indirect calorimetry (IC) to estimate energy needs, and supplementing protein up to 1.2 g/kg/day after stabilization. IC has gained importance in assessing energy needs but is still underused in the ICU. EN is preferred because it maintains intestinal integrity, reduces the risk of infections, and is recommended within the first 48 h of ICU admission. PN is used when EN is infeasible, but it increases the risk of infection. By integrating metabolomics with transcriptomic and genomic data, we can gain a deeper understanding of the effect of nutrition on cellular homeostasis, facilitating personalized treatments and enhancing the recovery of critically ill patients. Conclusions: AI is becoming increasingly important in monitoring and evaluating artificial nutrition, providing a more accurate and efficient alternative to traditional methods. AI can assist in identifying and managing malnutrition and is effective for estimating caloric and nutrient intake. AI minimizes human error, enables continuous monitoring, and integrates various data sources. The nutritional care of critically ill patients requires collaboration among specialists from diverse fields, including physicians, nutritionists, pharmacists, radiologists, IT experts, and policymakers. Full article
(This article belongs to the Special Issue Nutritional Management in Intensive Care)
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18 pages, 3512 KB  
Review
The Effectiveness of Transabdominal Ultrasonography in Managing Chronic Constipation in the Elderly, with a Focus on the Underlying Pathological Conditions
by Noriaki Manabe, Minoru Fujita and Ken Haruma
Diagnostics 2025, 15(4), 476; https://doi.org/10.3390/diagnostics15040476 - 16 Feb 2025
Cited by 1 | Viewed by 2963
Abstract
Chronic constipation is more common in the elderly and associated with numerous diseases. For the diagnosis of chronic constipation in the elderly, it is essential to exclude constipation secondary to colorectal cancer or other causes. Chronic constipation in the elderly also often requires [...] Read more.
Chronic constipation is more common in the elderly and associated with numerous diseases. For the diagnosis of chronic constipation in the elderly, it is essential to exclude constipation secondary to colorectal cancer or other causes. Chronic constipation in the elderly also often requires lifestyle modifications, as well as drug treatments because of the involvement of pathologies such as reduced colonic transport capacity and rectal hyposensitivity. Therefore, it is extremely important to evaluate the pathophysiology of both the colon and the rectum. Transabdominal ultrasonography (TUS) is a key technique for providing comprehensive medical care and allows simultaneous functional assessment and exclusion of organic diseases related to constipation such as colorectal cancer. Although several studies have reported the clinical utility of TUS for chronic constipation, which includes its simplicity, noninvasiveness, and low cost, the majority were in children. Thus, there are limited studies in adults. Herein, we review the utility of TUS for indirect assessment of colonic transit time using several TUS parameters that can be applied clinically, as well as treatment options for chronic constipation. The constipation index (i.e., mean transverse diameter of the colon), assessed by TUS, is a useful indirect indicator of colonic transit time. If the constipation index is <21.2, increased fiber or treatment with osmotic agents should be used. If the constipation index is ≥21.2, then the ratio of the left to the right lateral colonic diameters should be evaluated. If this value is ≥0.5, a secretagogue or bile acid transporter inhibitor should be administered. It is noteworthy that nursing care is becoming increasingly important in Japan’s super-aging society. A significant proportion of nursing care is provided to patients with chronic constipation, a cohort that is predicted to grow in the future. In these patients, fecal masses often remain in the rectum, which may require an enema or stool extraction. Therefore, it is important to assess both the presence of feces in the rectum and the consistency of the feces. Recently, portable ultrasound (US) devices equipped with artificial intelligence have been developed and used clinically for treatment of patients with chronic constipation in nursing care. Rectal findings using portable US devices can aid in selecting appropriate constipation treatments. Thus, portable US will likely become increasingly important as a next-generation examination device in nursing care. TUS (including portable US) is noninvasive, simple, and repeatable and will become a fundamental modality in the management of chronic constipation. Full article
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12 pages, 1792 KB  
Article
Evaluation of Anti-Venom Potential of Areca catechu Seed Extract on Bungarus caeruleus Venom
by Veena More, Abdullatif Bin Muhsinah, G. S. Latha, Abdulfattah Yahya M. Alhazmi, Osama Abdulaziz Ibrahim, Abdulkarim S. Binshaya, Mater H. Mahnashi, Hassan H. Almasoudi, Harshitha Gangadharappa, Sahana Nagappa Maruthi, Sindhoora Rao, Bhavya Janardhan, Aejaz Abdullatif Khan, Uday M. Muddapur, Ibrahim Ahmed Shaikh and Sunil S. More
Separations 2022, 9(11), 360; https://doi.org/10.3390/separations9110360 - 9 Nov 2022
Cited by 5 | Viewed by 3568
Abstract
Areca catechu seeds and their extract/s are currently used to treat various ailments and infections including snakebites. The purpose of this investigation was to assess the inhibiting/neutralizing effect of ethyl acetate and aqueous ethanolic seed extracts of A. catechu on Bungarus caeruleus (krait) [...] Read more.
Areca catechu seeds and their extract/s are currently used to treat various ailments and infections including snakebites. The purpose of this investigation was to assess the inhibiting/neutralizing effect of ethyl acetate and aqueous ethanolic seed extracts of A. catechu on Bungarus caeruleus (krait) venom. The enzyme activities and their inhibition were evaluated using standard procedures (in vitro). In vivo studies were conducted using chick embryos and murine models. The extracts inhibited hyaluronidase and phospholipase A2 activities. Protease activity was neutralized by the aqueous ethanolic extract only. The IC50 value of aqueous ethanolic extract for hyaluronidase was 0.001 g/mL, while that for the ethyl acetate extract for phospholipase A2 was 0.006 g/mL. In addition, both the extracts neutralized the indirect hemolysis and fibrinogenolytic activity induced by B. caeruleus venom. The LD50 for the chick embryos was 4.9 µg/egg. The 50 and 100 µg aqueous ethanolic extracts neutralized the LD50 and the challenging dose (3LD50) of venom effectively in the chick embryo model. The LD50 of B. caeruleus venom in mice was 0.1927 µg/kg; the extract extended the survival time of the mice from 25 min to 30 and 35 min in 1:10 and 1:20 ((w/w) venom:extract) ratios, respectively. The extract also neutralized myotoxic activity. The A. catechu seed extract showed promising inhibitory properties against B. caeruleus venom. In this regard, academia and industries should work collaboratively to develop and formulate a cost-effective first-aid drug. Full article
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1 pages, 185 KB  
Abstract
Patient-Centric Drug Product Design: Case Studies for Special Populations
by Isabel F. Almeida
Med. Sci. Forum 2022, 14(1), 130; https://doi.org/10.3390/ECMC2022-13189 - 1 Nov 2022
Viewed by 1190
Abstract
Medication non-adherence poses considerable challenges in managing chronic diseases and is associated with almost 200,000 deaths and EUR 80–125 billion in potentially preventable direct (e.g., hospitalizations, waste of medication) and indirect (e.g., work productivity losses) costs in the European Union alone. The increasing [...] Read more.
Medication non-adherence poses considerable challenges in managing chronic diseases and is associated with almost 200,000 deaths and EUR 80–125 billion in potentially preventable direct (e.g., hospitalizations, waste of medication) and indirect (e.g., work productivity losses) costs in the European Union alone. The increasing awareness of the contribution of the acceptability of drug products by the patient to medication adherence and clinical outcomes is driving the integration of patient-centric drug product design (PCDPD) into the pharmaceutical development process. Regulatory agencies have addressed the relevancy of placing the patient at the center of pharmaceutical development. The EMA has issued guidelines/reflection papers for pediatric and older populations while the FDA has developed a series of guidance documents on patient focused drug development with the primary goal to better incorporate the patient’s voice in drug development and evaluation. PCDPD can be defined as the process of identifying the comprehensive needs of the target patient population to support the design of drug products. Three major factors are analyzed in PCDPD, namely, the patient, drug, and drug product characteristics. This systematic approach integrates this insight, which is translated to a target product profile (TPP) to drive the pharmaceutical product design process. Two case studies are presented focused on the pediatric population and on patients with a chronic skin disorder (psoriasis), which will highlight the roadmap for a successful PCDPD. Full article
(This article belongs to the Proceedings of The 8th International Electronic Conference on Medicinal Chemistry)
25 pages, 2039 KB  
Article
Social and Behavioral Theories and Physician’s Prescription Behavior
by Rizwan Raheem Ahmed, Dalia Streimikiene, Josef Abrhám, Justas Streimikis and Jolita Vveinhardt
Sustainability 2020, 12(8), 3379; https://doi.org/10.3390/su12083379 - 21 Apr 2020
Cited by 13 | Viewed by 9339
Abstract
The efficacy, safety, and cost of medication are the major concerns for a patient; thus, this research addresses factors that influence the physician’s prescription behavior. The objective of the undertaken study is the empirical testing of a novel conceptual model that was newly [...] Read more.
The efficacy, safety, and cost of medication are the major concerns for a patient; thus, this research addresses factors that influence the physician’s prescription behavior. The objective of the undertaken study is the empirical testing of a novel conceptual model that was newly developed by the previous literature, which is based on behavioral and social theories. The considered model explains the association between marketing efforts, pharmacist factors, patient characteristics, and the physician’s decision to prescribe a drug. This unique model also includes the influence of cost and benefit ratio, drug characteristics, physician’s persistence, and trustworthiness as moderating variables. This model is useful for analyzing the prospects of marketing. We have collected 984 physicians’ responses from the urban centers of Pakistan through a structured questionnaire. We have used Structural equation modelling (SEM) based multivariate techniques such as exploratory and confirmatory factor analysis, and conditional process modelling to explore the direct and indirect relationship amongst the exogenous, moderating, and endogenous variables. The findings of the study demonstrated that marketing efforts, patient’s characteristics, and pharmacist factors have a positive and significant influence on the physician’s decision to prescribe medicines. The moderation analysis exhibited the significant effect of drug characteristics, cost–benefit ratio, physician’s persistence, and trustworthiness in a relationship between exogenous and endogenous variables. The results of the undertaken study are helpful for the marketers of the pharmaceutical industry to save wasteful marketing expenditures for the product portfolios, and measured variables may help to make meaningful marketing strategies for the physician’s prescription that provide optimum Returns on Investment (ROI) of their investments. Full article
(This article belongs to the Special Issue Behavior and Marketing for Sustainability)
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12 pages, 187 KB  
Article
Improving Protocol Design Feasibility to Drive Drug Development Economics and Performance
by Kenneth Getz
Int. J. Environ. Res. Public Health 2014, 11(5), 5069-5080; https://doi.org/10.3390/ijerph110505069 - 12 May 2014
Cited by 40 | Viewed by 9323
Abstract
Protocol design complexity has increased substantially during the past decade and this in turn has adversely impacted drug development economics and performance. This article reviews the results of two major Tufts Center for the Study of Drug Development studies quantifying the direct cost [...] Read more.
Protocol design complexity has increased substantially during the past decade and this in turn has adversely impacted drug development economics and performance. This article reviews the results of two major Tufts Center for the Study of Drug Development studies quantifying the direct cost of conducting less essential and unnecessary protocol procedures and of implementing amendments to protocol designs. Indirect costs including personnel time, work load and cycle time delays associated with complex protocol designs are also discussed. The author concludes with an overview of steps that research sponsors are taking to improve protocol design feasibility. Full article
(This article belongs to the Special Issue Economics of New Drug Development and Approval)
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17 pages, 3470 KB  
Article
Cost-Effectiveness of Lapatinib plus Letrozole in her2-Positive, Hormone Receptor–Positive Metastatic Breast Cancer in Canada
by T.E. Delea, J. Amdahl, A. Chit and M.M. Amonkar
Curr. Oncol. 2013, 20(5), 371-387; https://doi.org/10.3747/co.20.1394 - 1 Oct 2013
Cited by 22 | Viewed by 1294
Abstract
Background: The cost-effectiveness of first-line treatment with lapatinib plus letrozole for postmenopausal women with hormone receptor–positive (HR+), human epidermal growth factor receptor 2–positive (HER2+) metastatic breast cancer (mBC) has not been assessed from the Canadian health [...] Read more.
Background: The cost-effectiveness of first-line treatment with lapatinib plus letrozole for postmenopausal women with hormone receptor–positive (HR+), human epidermal growth factor receptor 2–positive (HER2+) metastatic breast cancer (mBC) has not been assessed from the Canadian health care system and societal perspectives. Methods: A partitioned survival analysis model with 3 health states (alive, pre-progression; alive, post-progression; dead) was developed to estimate direct and indirect costs and quality-adjusted life years (QALYS) with lapatinib–letrozole, letrozole, anastrozole, or trastuzumab–anastrozole as first-line treatment. Clinical inputs for lapatinib–letrozole and letrozole were taken from the EGF30008 trial (NCT00073528). Clinical inputs for anastrozole and trastuzumab–anastrozole were taken from a network meta-analysis of published studies. Drug costs were obtained from the manufacturer’s price list, the Quebec list of medications, and imsBrogan. Other costs were taken from the Ontario Health Insurance Plan’s Schedule of Benefits and Fees and published studies. A 10-year time horizon was used. Costs and QALYS were discounted at 5% annually. Deterministic and probabilistic sensitivity analyses were performed to assess the effects of changes in model parameters. Results: Quality-adjusted life years gained with lapatinib–letrozole were 0.236 compared with trastuzumab–anastrozole, 0.440 compared with letrozole, and 0.568 compared with anastrozole. Assuming a health care system perspective, incremental costs were $5,805, $67,029, and $67,472 respectively. Given a cost per QALY threshold of $100,000, the probability that lapatinib–letrozole is preferred was 21% compared with letrozole, 36% compared with anastrozole, and 68% compared with trastuzumab–anastrozole. Results from the societal perspective were similar. Conclusions: In postmenopausal women with HR+/HRR2+ mbc receiving first-line treatment, lapatinib–letrozole may not be cost-effective compared with letrozole or anastrozole, but may be cost-effective compared with trastuzumab–anastrozole. Full article
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