Product Labeling Research Articles

Optimizing Byproduct Processing for Clean Label Foods: Avocado and MSM‐Tambaqui With a Focus on Zero Waste

ABSTRACTAgricultural byproducts, often discarded, possess significant nutritional value and technological potential. This study investigates the efficacy of ethanolic‐water extracts from avocado (Persea americana Mill.) byproducts, obtained with minimal solvent use through optimized extraction, in enhancing the stability of mechanically separated meat‐tambaqui (Colossoma macropomum) burgers, a high‐fat Amazonian fish. 2000 ppm of avocado seed and peel extract were applied in shelf‐life tests conducted under refrigeration and freezing conditions to evaluate the stability of the burgers. The results demonstrated that the bioactive compounds from avocado byproducts resulted in lower TBARS values, indicating strong antioxidant properties, reduced formation of volatile nitrogen compounds, and color maintenance than sodium erythorbate. Monounsaturated fatty acids (MUFAs) and polyunsaturated fatty acids (PUFAs) were preserved using bioactive ethanolic‐water extracts, and the protein content was improved compared to the control, enhancing nutritional quality. This study highlights the potential of using agri‐food byproducts, especially for application in highly perishable items such as fish, promoting the development of clean label products, thus supporting a more efficient and environmentally friendly food industry focusing on the circular economy.

Population modeling analyses of crizotinib in pediatric patients with ALK-positive advanced cancers.

Alterations in the ALK (anaplastic lymphoma kinase) gene play a critical role in pathogenesis of anaplastic large cell lymphoma (ALCL). Crizotinib is a small molecule competitive inhibitor of ALK, ROS1, and MET kinases and was approved for pediatric patients with ALK-positive relapsed or refractory, systemic ALCL, and ALK-positive unresectable, recurrent, or refractory inflammatory myofibroblastic tumors (IMT). Crizotinib data from pediatric patients with relapsed or refractory solid tumors, IMT, or ALCL were included in the analyses. All patients received crizotinib orally at doses ranging from 100 to 365mg/m2 twice daily (BID). PopPK analyses were conducted to characterize crizotinib disposition in pediatric patients. Exposure-response (ER) safety and antitumor analyses were conducted to characterize relationships between crizotinib dose or exposure with safety and antitumor activity endpoints of interest. The population pharmacokinetic (popPK), ER safety, and ER antitumor analysis included 98, 110, and 36 pediatric patients, respectively. A one-compartment pharmacokinetic model with allometric scaling, first-order elimination, and first-order absorption with lag time adequately described the data. Natural log-transformed model-predicted crizotinib AUCss (steady-state area under the concentration-time curve) demonstrated a significant, positive relationship with Grade ≥3 NEUTROPENIA and Any Grade VISION DISORDER. Crizotinib dose demonstrated a positive relationship with objective response rate. No significant differences in PK were identified across a wide range of ages or across tumor types, suggesting body surface area (BSA)-based dosing adequately adjusted for differences in patient size to achieve similar systemic crizotinib exposures across young children and adolescent pediatric patients. None of the myelosuppressive events except Grade ≥3 NEUTROPENIA had significant relationships identified with crizotinib dose or exposure, suggesting crizotinib is a tolerable treatment with less hematological toxicity than traditional chemotherapy regimens for pediatric patients with ALK-mutated cancers. Results from the presented analyses support the pediatric dosing recommendations in the product label.

177Lu-PSMA-617 versus a change of androgen receptor pathway inhibitor therapy for taxane-naive patients with progressive metastatic castration-resistant prostate cancer (PSMAfore): a phase 3, randomised, controlled trial.

[177Lu]Lu-PSMA-617 (177Lu-PSMA-617) prolongs radiographic progression-free survival and overall survival in patients with metastatic castration-resistant prostate cancer previously treated with androgen receptor pathway inhibitor (ARPI) and taxane therapy. We aimed to investigate the efficacy of 177Lu-PSMA-617 in patients with taxane-naive metastatic castration-resistant prostate cancer. In this phase 3, randomised, controlled trial conducted at 74 sites across Europe and North America, taxane-naive patients with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer who had progressed once on a previous ARPI were randomly allocated (1:1) to open-label, intravenous 177Lu-PSMA-617 at a dosage of 7·4 GBq (200 mCi) ± 10% once every 6 weeks for six cycles, or a change of ARPI (to abiraterone or enzalutamide, administered orally on a continuous basis per product labelling). Crossover from ARPI change to 177Lu-PSMA-617 was allowed after centrally confirmed radiographic progression. The primary endpoint was radiographic progression-free survival, defined as the time from randomisation until radiographic progression or death, assessed in the intention-to-treat population. Safety was a secondary endpoint. This study is registered with ClinicalTrials.gov (NCT04689828) and is ongoing. In this primary report of the study, we present primary (first data cutoff) and updated (third data cutoff) analyses of radiographic progression-free survival; all other data are based on the third data cutoff. Overall, of the 585 patients screened, 468 met all eligibility criteria and were randomly allocated between June 15, 2021 and Oct 7, 2022 to receive 177Lu-PSMA-617 (234 [50%] patients) or ARPI change (234 [50%]). Baseline characteristics were mostly similar between groups; median number of 177Lu-PSMA-617 cycles was 6·0 (IQR 4·0-6·0). Of patients assigned to ARPI change, 134 (57%) crossed over to receive 177Lu-PSMA-617. In the primary analysis (median time from randomisation to first data cutoff 7·26 months [IQR 3·38-10·55]), the median radiographic progression-free survival was 9·30 months (95% CI 6·77-not estimable) in the 177Lu-PSMA-617 group versus 5·55 months (4·04-5·95) in the ARPI change group (hazard ratio [HR] 0·41 [95% CI 0·29-0·56]; p<0·0001). In the updated analysis at time of the third data cutoff (median time from randomisation to third data cutoff 24·11 months [IQR 20·24-27·40]), median radiographic progression-free survival was 11·60 months (95% CI 9·30-14·19) in the 177Lu-PSMA-617 group versus 5·59 months (4·21-5·95) in the ARPI change group (HR 0·49 [95% CI 0·39-0·61]). The incidence of grade 3-5 adverse events was lower in the 177Lu-PSMA-617 group (at least one event in 81 [36%] of 227 patients; four [2%] grade 5 [none treatment related]) than the ARPI change group (112 [48%] of 232; five [2%] grade 5 [one treatment related]). 177Lu-PSMA-617 prolonged radiographic progression-free survival relative to ARPI change, with a favourable safety profile. For patients with PSMA-positive metastatic castration-resistant prostate cancer who are being considered for a change of ARPI after progression on a previous ARPI, 177Lu-PSMA-617 may be an effective treatment alternative. Novartis.

Practical Recommendations on Laboratory Monitoring in Patients with Atopic Dermatitis on Oral JAK Inhibitors.

Oral Janus kinase inhibitors (JAKi), a class of advanced targeted systemic therapy, have demonstrated efficacy and safety in the treatment of moderate-to-severe atopic dermatitis (AD). Like other small molecules, oral JAKi have the potential for off-target effects including laboratory-related adverse events (AEs). Product labels for oral JAKi recommend an initial laboratory assessment and follow-up 4-12weeks later to monitor for potential changes, based on evidence from clinical trials across therapeutic indications for oral JAKi, which may not reflect a population of moderate-to-severe AD patients typically seen in routine clinical practice. To address this gap, a panel of eight dermatologists with clinical and research experience with oral JAKi for the management of AD conducted a targeted review of the literature focused on key laboratory-related AEs associated with oral JAKi in the moderate-to-severe AD population. Based on the synthesis of evidence and informed opinion, a set of best practice statements related to fundamental standards of care and consensus recommendations on laboratory monitoring were suggested, and level of agreement was ascertained using a Likert scale from 0 to 100. There was a high level of agreement on three of the four suggested recommendations related to assessment and monitoring of key laboratory parameters and to dose reduction or switching in response to laboratory changes; there was a lower level of agreement related to the frequency of ongoing laboratory monitoring. Appropriate patient selection and laboratory assessment is an important strategy to mitigate the potential risks associated with oral JAKi when treating AD.

Meminimasi Waste pada Distribution Center Area Non Food dengan Pendekatan Lean Warehousing di Perusahaan Retail PT XYZ

PT. XYZ is a minimarket retail company that sells various needs of the community. PT One of the DCs is located in the city of Batam, this DC still has some waste that occurs in its warehousing activities so research needs to be carried out to eliminate this waste. To eliminate problems, an approach was taken using lean warehousing with the tools used being Value Stream Mapping (VSM), Process Activity Mapping (PAM), Gemba shikumi, 5 whys, Lean matrix 2 in the activity mapping process (Process Activity Mapping/PAM) in a warehouse which identified 18 Non-Value Added activities and after processing it with Gemba Shikumi, 4 critical wastes were obtained, consisting of errors in handover evidence, re-inputting data, errors in picking goods, and looking for replacement goods due to incorrect picking. The 4 (four) wastes were given proposals for improving employee training, restructuring the issuing flow, making product labels, internal audits and receiving automation systems. These improvement recommendations are estimated to reduce warehousing process time by 6720 seconds or the equivalent of 1.87 hours. This figure is quite significant because it represents a time reduction of 19.83% from the previous total warehousing process time which reached 33,887 seconds or 9.42 hours.

Consumer Awareness and Contemporary Policy Regulations on Artificial Food Colourant Safety in India

The purpose of this research is to focus on the most practised Artificial Food Colourants (AFCs) creating a demand in the consumer food market and neglecting food safety by the stakeholders, as these AFCs have been proven to be harmful to human health. The problem question that has been addressed here is whether the labeling policy and the consumer awareness of AFC are in tandem with; how the Indian judiciary fared in delivering their judgements towards the prevalence of non-permitted AFCs in the Indian food market to tell them as successful for the healthier consumer food industry. The main objective is to examine the consumers’s awareness on AFC on the International Numbering System for Food Additives (INS) and their mentioning on the label of food products along with the regulatory measures for approvals of AFCs in Europe, USA and India for comparison. It is revealed that consumers’ awareness of INS is not very significant; FSSAI permits only eight AFCs for consumption, nevertheless, other non-permitted AFCs were also found to be used and the Indian government has acted responsibly on various occasions by entering the manufacturing premises to inspect the food, collect samples for testing the adulteration by submitting to the food analyst, thereby curbing such activities and grabbing such offenders to the court. The concept of food safety dimensions in consensus with AFC practices, the health and legal issues associated with AFC consumption, the Indian Government’s policies and the response of the judiciary related to food colourant safety are discussed in this paper. A doctrinal research method is followed by analysing the legal literature such as the regulatory provisions, government policies and noteworthy cases from the Indian judiciary and drawing support from empirical research evidencing the poor knowledge of consumers on AFCs being added in the food. Therefore, a serious policy awareness among consumers with respect to AFCs, being responsible and taking ownership towards one’s own health and their family members by taking steps in questioning the consumer forum and avoiding purchase of such packed food which does not adhere to the labeling standards and being consumer friendly, stringent regulations in labeling standards of food in the USA and Europe due to import nature of their products are the need of the hour.

Who has an appetite for insects? Identifying segments of early adopters of insect-based food and their product attribute preferences: Insights from a choice experiment study in Germany

Despite well-documented scepticism among Western consumers about eating insects, there are groups of potential early adopters who will form the initial market for insect-based food. Understanding the different preferences of these potential early adopters is key to developing effective targeted marketing actions. This study aimed to identify segments of potential early adopters and their distinct product attribute preferences. Via an online survey in Germany (N = 922), we conducted discrete choice experiments using real packaging of insect-based meatballs and crackers. Latent class logit analysis identified four consumer segments for each product, three of which showed a willingness to buy the products. While these potential consumer groups varied in their price sensitivity and insect labelling preferences, they all attached the greatest importance to naturalness claims. Interestingly, sustainability and nutritional information were not top priorities for all consumers; instead we observed the importance of an institutional trust indicator, especially for unconvinced consumers. In conclusion, the results of the present study provide interesting insights for both researchers and practitioners to make informed marketing decisions in the development and labelling of insect-based products.

Application of Conventional and Hybrid Thermal-Enzymatic Modified Wheat Flours as Clean Label Bread Improvers

A new flour blend (F) composed of selected milling and leaving passages with a high content of non-starch polysaccharides underwent thermal (T), hydrothermal (H) or hybrid processing and was used along with cellulase (C) and cellulase-xylanase complex (CX) to produce bread. This modified flour can be considered a clean label product. In this study, blends of common and treated flours were tested for dough properties and rheology. The modified flours were added at 10 and 20% to the base wheat flour. A pan bread was then prepared to test their suitability for bread baking. Dough and bread properties were subsequently assessed. Accordingly, dough with added thermally, hydrothermally, and hybrid modified flours revealed differences in rheology. Addition of hybrid enzymatic-hydrothermal treated flour increased dough tenacity by 23% and baking strength by 26%, but decreased dough extensibility by 19%, whereas hybrid enzymatic-thermal modification increased water absorption by 6% and bread yield from 146.77% to 150.02% when modified flour was added at 20%. Breads with added modified flours demonstrated a 16% increase in bread volume, 8% lower baking loss, and 14% greater density, with no negative effect on color and texture. Thus, hybrid thermal-enzymatic treatment of the developed flours can be recommended as a suitable method for enhancing the utilization of waste flour fractions and increasing their value by enabling them to be considered as clean label bread improvers.

Reduced Effect of Commercial Leonardite and Seaweed Extract on Lettuce Growth under Mineral, Organic, and No Fertilization Regimes

In this study, two commercial products based on the main groups of contemporary biostimulants—a commercial leonardite and a seaweed extract—were tested with the objective of assessing the conditions under which they can enhance lettuce (Lactuca sativa L.) performance, particularly to determine if synergies with conventional fertilization methods can be observed. The experimental protocol was arranged as a factorial design with two factors: organic or mineral fertilization × plant biostimulant. The organic or mineral fertilization factor included five levels: two rates of a nitrogen (N) fertilizer (40 (Nmin40) and 80 (Nmin80) kg ha−1 of N), the same N rates applied as an organic amendment (Norg40 and Norg80), and an unfertilized control (N0). The plant biostimulants used were a commercial leonardite (leonardite) for soil application before planting, a commercial seaweed extract (algae) for foliar application during the growing season, and a control without plant biostimulant. Leonardite significantly increased lettuce dry matter yield (DMY) compared to the control only in the first growing cycle (11.5 and 13.5 g plant−1) and showed no significant interaction with conventional fertilization. It also consistently increased phosphorus (P) levels in the plant tissues. The seaweed extract did not show any effect on the plant, nor did it have any interactions with conventional fertilization regarding DMY. In contrast, with mineral fertilization, lettuce DMY increased from 8.0 and 4.0 g plant−1 (N0) to 22.2 and 12.0 g plant−1 (Nmin80) in the first and second growing cycles, respectively. The response to organic fertilization was lower, yet DMY still increased from 4.0 to 8.1 g plant−1 in the second growing cycle. Generally, this type of plant biostimulant is tested under some form of environmental stress, where it often yields positive results. In this study, the optimal cultivation conditions maintained for the lettuce in the pots likely explain the limited response to the biostimulants. This study suggests that the product labels should more clearly indicate whether they are recommended for general cultivation conditions or specifically for situations where a particular environmental stress can be anticipated.

Clinicians' Preferences for Sphingosine-1-Phosphate Receptor Modulators in Multiple Sclerosis Based on Clinical Management Considerations: A Choice Experiment.

Four sphingosine-1-phosphate receptor (S1PR) modulators are currently available in the USA for treating relapsing forms of multiple sclerosis (MS). These S1PR modulators have similar efficacy. Clinicians may therefore consider other factors, such as clinical management considerations, when distinguishing among treatments. This study estimated which S1PR modulator clinicians would choose on the basis of a treatment's clinical management and quantified how individual aspects of clinical management might drive this choice. A multi-criteria decision analysis (MCDA) was conducted on the basis of clinical management preferences elicited in a discrete choice experiment (DCE) and real-world clinical management profiles of the S1PR modulators currently available to treat relapsing forms of MS (fingolimod, ozanimod, ponesimod, siponimod). The DCE was completed by neurologists in the USA experienced in treating MS and included eight clinical management attributes: first-dose observations, genotyping, liver function tests, eye exams, drug-drug interactions, interactions with antidepressants, interactions with foods high in tyramine, and immune system recovery time. Attribute levels were selected on the basis of S1PR modulator product labels. In the MCDA, partial MCDA scores were created for each attribute and summed to produce an overall MCDA score for each S1PR modulator. The DCE was completed by 200 neurologists. The overall MCDA score was highest for ponesimod (4.78 points), followed by siponimod (4.10 points), fingolimod (3.61 points), and ozanimod (2.38 points). Having fewer drug-drug interactions contributed most to the overall scores (up to 1.56 points), followed by having no first-dose observations (0.95 points), the shortest immune system recovery time (0.94 points), and not interacting with foods high in tyramine (0.86 points). When considering clinical management convenience, the average US-based neurologist treating MS is likely to choose ponesimod over siponimod, fingolimod, or ozanimod. The strongest driver of preferences was the number of drug-drug interactions. This information can help inform recommendations for the treatment of MS and facilitate shared decision-making between clinicians and patients.

Analysis of US Marketed Artemisinin Supplements for Use in Dogs.

Oral artemisinin has antiparasitic activity and may help improve treatment success rates in dogs infected with Babesia gibsoni. However, these artemisinin products are unapproved and unregulated botanical supplements. They have not been evaluated for safety and efficacy or for strength, purity, or quality compared with a reference standard. Before considering these products for a clinical study, we evaluated the strength of four suppliers of artemisinin capsules using an high-performance liquid chromatography method validated in our laboratory. We found that the four artemisinin-labeled products that were tested had high within product and between product variability in capsule strength compared with the stated capsule strength on the product label. No products met the acceptance criteria of the United States Pharmacopeia and International Council for Harmonisation (ICH) as well as the criteria adapted by the authors. One product had no detectable artemisinin, and the other three products were much higher than the stated label strength. The results of this study reinforce the importance of testing unapproved and unregulated supplements before recommending a supplement for clinical use in dogs.

Analysis of chicken and pig DNA content in commercial dry foods for adult cats.

Among pets, cats are the most popular in Europe. Despite the fact, the interest in the safety and quality of their food is much lower compared to the interest of caregivers in the nutrition of dogs. In this research, 27 commercial cat foods were analyzed for mislabeled component composition. Cat foods were divided into a control group, a group of fish foods and a group of other foods with alternative sources of animal protein. Chicken and pig DNA detection was performed using real-time PCR. In this research, 100% of the cat foods contained chicken DNA and 96% of the foods - pig DNA, despite the lack of declaration of these ingredients on the product label. The results indicate that cat food appear to be mislabeled to an even greater extent than dog food. Moreover, manufacturers' declarations in terms of ingredient composition do not reflect the actual composition of commercial products available on the market and intended for everyday feeding of animals. Mislabeling of these products also poses a risk for animals suffering from food allergies.

Ocular adverse events associated with antibody-drug conjugates in oncology: a pharmacovigilance study based on FDA adverse event reporting system (FAERS).

Antibody-drug conjugates (ADCs) have emerged as the focus and hotspots in the cancer field, yet the accompanying ocular toxicity has often been underestimated. We aimed to comprehensively and comparatively analyze the risk of ocular toxicity associated with various ADCs using the FDA Adverse Event Reporting System (FAERS) database. Data were extracted from the FAERS database from Q3 2011 to Q3 2023. We analyzed the clinical characteristics of ADCs-related ocular adverse events (AEs). These data were further mined by proportional analysis and Bayesian approach to detect signals of ADCs-induced ocular AEs. Moreover, the time to onset of ocular toxicity was also evaluated. A total of 1,246 cases of ocular AEs were attributed to ADCs. Ocular toxicity signals were observed in patients treated with belantamab mafodotin, brentuximab vedotin, enfortumab vedotin, mirvetuximab soravtansine, sacituzumab govitecan, trastuzumab deruxtecan, and trastuzumab emtansine. Of these, belantamab mafodotin, trastuzumab emtansine, and mirvetuximab soravtansine, whose payloads are microtubule polymerization inhibitors, were more susceptible to ocular toxicity. The ten most common ADCs-related ocular AEs signals are keratopathy [ROR = 1,273.52, 95% CI (1,129.26-1,436.21)], visual acuity reduced [ROR = 22.83, 95% CI (21.2-24.58)], dry eye [ROR = 9.69, 95% CI (8.81-10.66)], night blindness [ROR = 259.87, 95% CI (228.23-295.89)], vision blurred [ROR = 1.78, 95% CI (1.57-2.02)], photophobia [ROR = 10.45, 95% CI (9.07-12.05)], foreign body sensation in eyes [ROR = 23.35, 95% CI (19.88-27.42)], ocular toxicity [ROR = 144.62, 95% CI (117.3-178.32)], punctate keratitis [ROR = 126.21, 95% CI (101.66-156.69)], eye disorder [ROR = 2.71, 95% CI (2.21-3.32)]. In terms of onset time, sacituzumab govitecan displayed an earlier onset of 21days, while trastuzumab deruxtecan exhibited the latest onset of 223days. ADCs may increase the risk of ocular toxicity in cancer patients, leading to serious mortality. With the widespread application of newly launched ADCs, combining the FAERS data with other data sources is crucial for monitoring the ocular toxicity of ADCs. In addition, novel ocular toxicity signals not documented in product labeling were detected. Further research will be necessary to validate our findings in the future.

Phytopharmacasia Stimuno Syrup as a Traditional Medicine

This study aims to evaluate the efficacy and safety of Stimuno Syrup as an immunomodulator in improving the immune system. A descriptive-analytical approach is used to collect information on the composition, active ingredients, and efficacy claims of Stimuno Syrup from various reliable sources, including scientific literature and information from the Food and Drug Supervisory Agency (BPOM). The composition analysis of Stimuno Syrup includes the identification of the main active ingredients, the content of the active substances, as well as the evaluation of the product packaging and label. Furthermore, empirical data from preclinical and clinical studies were evaluated to provide a comprehensive picture of the efficacy and safety of Stimuno Syrup. The results of this study are expected to provide a clearer understanding of the potential of traditional medicine in the modern context as well as provide stronger scientific support for the use of Stimuno Syrup as an alternative in maintaining health and increasing immunity.

Analysis of proper ink management impact on overall environmental equipment efficiency for sustainability

Printing as a process itself generates many environmental concerns. The paper addresses ink management in terms of environmental issues in the label printing industry, focusing on its environmental implications. The goal is to demonstrate how a proper ink management system impacts overall printing process efficiency and environmental sustainability for printing companies. The paper introduces an empirical approach to managing components for label and packaging production, utilizing automatic ink dispensing systems. The results demonstrate that the proper management of ink dispensing to minimize waste in packaging printing is crucial for optimizing operating print costs, potentially reducing the amount of ink needed to prepare colors by 52% and achieving energy savings of 37%. This approach fulfills the goal of sustainability by addressing environmental, economic, and social concerns. By optimizing ink usage and energy consumption, companies can significantly reduce operating costs and enhance economic performance. Simultaneously, these practices improve product quality, meet consumer demands for sustainable packaging, and create better working conditions for employees. Future directions and practical implications for supporting operational excellence in production are also discussed.

Population Pharmacokinetics (PopPK) Support for Pediatric Dosing of Biological Products.

This study assesses the use of population pharmacokinetics (PopPK) in supporting pediatric dosing of novel biological drug products. The labeling for biologic drug products approved by the US Food and Drug Administration (FDA) from 2002 until 2021 was reviewed to identify those with a pediatric indication. For the drugs with a pediatric indication, the dosing regimen(s) based on age groups, dosing strategy, the use of PopPK to support the dose, and the types of pediatric clinical trials were reviewed. Data were collected from FDA's review documents and product labels on the Drugs@FDA website, and as needed, more clinical trial details were collected from PubMed and clinicaltrials.gov. The role of PopPK analyses in dosing was captured when mentioned in the label or review as playing a role in selecting the approved pediatric dose and/or in verifying the adequacy of the studied dose to support labeling. Between 2002 and 2021, FDA approved 169 biological products, and 78 of 169 (46%) products have an approved indication for which the label contains dosing recommendations for pediatric use. For the 78 products approved in pediatrics, there was a total of 180 clinical trials that included pediatric patients. Phase 3 pediatric trials commonly supported pediatric approval and dosing for the reviewed products (64%, 50/78 products; 56.1%, 101/180 trials). PopPK analyses were reported to play a critical role in dose selection, prediction, and verification for 40 of the 78 products (51%), including informing pediatric dosing in the absence of pediatric data (e.g., drugs approved under animal rule), comparing exposures to the exposure range observed in adults, and informing alternative dosing strategies in certain age or body weight groups. PopPK analyses have been applied in a variety of ways to inform pediatric dosing and support extrapolation from adult data or other pediatric age groups for biologics. Understanding and learning from these past cases on the use of pharmacometrics tools to support pediatric dosing of biological products can inform future pediatric development programs.

Pharmacokinetic Bioequivalence between Generic and Originator Orally Inhaled Drug Products: Validity of Administration of Doses above the Approved Single Maximum Dose.

Pharmacokinetic bioequivalence of orally inhaled drug products is a critical component of the US FDA's "weight of evidence" approach, and it can serve as the sole indicator of safety and effectiveness of follow-on inhalation products approved in Europe and some other geographic areas. The approved labels of the orally inhaled drug products recommend the maximum number of actuations that can be administered in a single dose on one occasion. This single maximum dose may consist of one or more inhalations depending upon the product. Bioequivalence studies for the inhalation drug product registrations in the US and EU have employed single and multiple actuation doses, in some cases over and above the approved single maximum labeled doses, thus, inconsistent with the approved labeling of the reference products. Pharmacokinetics of inhaled drug products after single and multiple doses may be different, with implications for bioequivalence determined at single and multiple doses. Scientific literature indicates that the relative bioavailability of the Test and Reference products may differ between administrations of doses in one and multiple inhalations. Multiple doses not only alter the pharmacokinetics but also may reduce the sensitivity of the bioassay to actual differences between the Test and Reference product performances. Ability of the pharmacokinetic bioassay to accurately determine the extent of difference between two products may also be substantially reduced at high doses. Therefore, in our opinion, pharmacokinetic bioequivalence to support regulatory approvals of inhalation products at doses above the recommended single maximum dose should be avoided. Furthermore, the bioequivalence of products (if any) established at doses exceeding the approved single maximum doses should be revisited to determine if the products maintain bioequivalence when evaluated at the clinically relevant single maximum doses.

When being smart trumps AI: An exploration into consumer preferences for smart vs. AI-powered products

Prior to the rapid growth of Artificial Intelligence (“AI”) in the consumer market, smart products received great attention from marketers and consumers. Given the recent increase in attention to AI technologies, this research explores consumers' preferences and intentions when products are framed as “smart” versus “AI-powered.” While previous literature has explored AI products and smart products individually, little is known about consumers’ preferences between the two products simultaneously. Three empirical experiments demonstrate that consumers show preference for products labeled as “smart” over those labeled as “AI-powered.” This preference is mediated by enhanced learning anxiety related to AI. The findings provide insights for marketers applying message framing, suggesting that labeling products as “smart” may evoke more favorable consumer behavior compared to the “AI-powered” label. Moreover, this research significantly contributes to the existing literature on perceptions and intentions related to AI and smart products by concurrently exploring consumer preferences regarding both smart products and AI-powered products.

Real-world pharmacovigilance analysis of galsulfase: a study based on the FDA adverse event reporting system (FAERS) database.

Associated with enzyme deficiencies causing glycosaminoglycans (GAGs) accumulation, mucopolysaccharidosis type VI (MPS VI) is lysosomal storage disorder. In the treatment of MPS VI, galsulfase (Naglazyme) is commonly used as an enzyme replacement therapy (ERT). There remains a need for comprehensive real-world data on its safety and associated adverse events (AEs). An analysis of the FDA Adverse Event Reporting System (FAERS) database will be conducted to identify potential risks and adverse reactions associated with galsulfase in real-life settings. The FAERS database was used to extract data from Q2 2005 to Q4 2023. A total of 20,281,876 reports were analyzed after duplicate elimination, with 3,195 AE reports related to galsulfase identified. The association between galsulfase and AEs was investigated by utilizing four algorithms: reporting odds ratio (ROR), proportional reporting ratio (PRR), Bayesian confidence propagation neural network (BCPNN), and multi-item gamma Poisson shrinker (MGPS). The analysis focused on the timing of onset, signs of AEs, and clinical significance. Twenty seven organ systems were involved, and significant system organ classes (SOCs) included respiratory, thoracic and mediastinal disorders, and infections and infestations. At the PT level, 72PTs corresponding to 15 SOCs were identified, with some AEs not previously mentioned in the product label. AEs associated with galsulfase had a median onset time of 1,471days, with over half of the cases occurred within the first 5years of treatment initiation. This investigation delivers an exhaustive and indicative assessment of galsulfase's safety profile, grounded in authentic, real-world evidence. The findings emphasis the importance of continuous safety surveillance and the emergence of new AEs. The identification of previously unreported urologic adverse events, such as glomerulonephritis membranous and nephritic syndrome, warrants further investigation. The study emphasizes the need for enhanced pharmacovigilance to ensure patient safety and the effectiveness of galsulfase treatment.

Organic Product Labels: The Credence towards Customers Choice of Buying Behaviour

Purpose: The organic food sales are not gaining more potential, due to limited buyers, because the customers have a paucity of product labels. This distrust has highly affected the company's profits. The purpose of the study is to ease these sceptics nature which is crucial for the organic food chain and also the government, emphasizing the necessity to enhance trust and openness in compliance. In order to ensure the credibility of the certified labels, companies have to adopt a set of rules and standards which result in a long-term effect on eco-favoured customers, and trust in the organic label creates a positive impact on customer choice of buying behaviour. Besides, companies also focus on conveying the right messages, so that customers can differentiate organic products from conventional ones. Design: This literature highlights various issues pertaining to the organic product label and customers’ choice of buying behaviour, and data is obtained from multiple reviews of literature, journals, and case studies. Findings: Labelling strategy may reduce information asymmetry between customers and the company because labelling strategy may influence product differentiation. Originality/Value: Studies encompass the certification scheme which is necessary for labelling organic products. Studies identify reading the labels customers easily identify product attributes that serve as a medium between company and end-users. Moreover, green labels, eco-labels, energy labels, and organic labels serve as certificates of organic products. Paper Type: Case study