Efficacy Of Pharmaceutical Products Research Articles

Advancing Pharmacovigilance: Safeguarding Drug Safety and Enhancing Public Health

Pharmacovigilance is integral to ensuring the safety and efficacy of pharmaceutical products throughout their lifecycle. This review explores the essential components of pharmacovigilance, highlighting its role in monitoring adverse drug reactions (ADRs), detecting safety signals, and managing risks associated with medications. Key components include adverse event reporting systems, advanced signal detection methodologies utilizing artificial intelligence and real-world data, rigorous data management and evaluation processes, and compliance with regulatory requirements. Effective communication strategies ensure dissemination of safety information to healthcare professionals and the public, promoting informed decisionmaking and enhancing patient safety. Challenges such as data quality, regulatory adaptation, and global harmonization are discussed, alongside future directions aimed at improving pharmacovigilance practices. By continuously evolving to integrate technological advancements and global collaboration, pharmacovigilance contributes significantly to public health by maintaining the integrity and safety of pharmaceutical therapies worldwide.

QUALITY ASSESSMENT AND STABILITY STUDIES OF METRONIDAZOLE TABLETS FORMULATIONS OBTAINED VIA CRYSTALLO CO-AGGLOMERATION TECHNIQUE

Stability studies are essential for assessing the quality, safety, and efficacy of pharmaceutical products, ensuring they maintain their properties over time. This study aimed to assess the stability of metronidazole tablets stored in a desiccator with charged silica gel following the International council for harmonization of Technical Requirements for Pharmaceuticals for Human Use guidelines. Metronidazole tablets were formulated from metronidazole co-agglomerates using different excipients by direct compression method and stored for 6 and 12 months at 25±2°C/60±5% relative humidity. Quality parameters such as weight variation, diameter, thickness, hardness, friability, content uniformity, and dissolution rate were evaluated at intervals using the United States Pharmacopeia – National Formulary and British Pharmacopeia specifications. The tablets maintained uniformity in weight, diameter, thickness and content over 12 months, meeting pharmacopeial standards. They exhibited high crushing strength, low friability, and consistent disintegration times (<5 min), across formulations and storage durations with no significant changes after storage, indicating stable performance. The sustained high crushing strength, friability ratio (CSFR) and crushing strength, friability, disintegration time (CSFR/Dt) ratios suggested high tablet strength and quality. In-vitro dissolution studies showed release rates of 87.31 – 100.81 %, with a significant decrease at 6 months within pharmacopeial standards but no change at 12 months. Content uniformity was maintained throughout storage. Metronidazole tablets formulated from crystallo co-agglomerates demonstrated good stability and mechanical strength over 12 months of storage. Storage in air-tight containers with desiccants at controlled room temperature (25±2°C) or below their relative humidities is recommended for maintaining tablet quality

Unlocking the electrochemical signature of Naringenin: Implications for screening in pharmaceutical formulations

Naringenin (NAR) is a versatile herbal flavonoid known for its broad pharmacological benefits, including antioxidant, anti-inflammatory, and anticancer properties. These properties underscore its potential and necessity for industrial applications within the pharmaceutical sector, making its detection and quantification crucial for ensuring the quality and efficacy of pharmaceutical products. Addressing the imperative for a sensitive and sustainable screening approach, this research leverages electrochemical analysis techniques including electrochemical impedance spectroscopy (EIS), cyclic voltammetry (CV), and differential pulse voltammetry (DPV). Complementary to experimental investigations, the electronic structure of NAR was probed using B3LYP/Def2-TZVPPD calculations alongside Fukui and dual descriptor analyses. Our findings delineate the dissociation kinetics of the hydroxyl groups within NAR, with particular emphasis on the phenolic group’s proton as the primary dissociation site, elucidating pivotal insights into the oxidation mechanism of NAR. Noteworthy is the irreversibility of the electrochemical oxidation process observed on both non-modified glassy carbon electrode (GCE) and gold electrode (GE), indicating a one-electron-one-proton mechanism. Utilizing the external calibration method and GCE, a linear range from 1.36 to 19.1 mg L-1 in Britton-Robinson (BR) supporting electrolyte was established, exhibiting a limit of detection (LOD) of 0.11 mg L-1 (R2 = 0.9945). For GE, the standard addition calibration approach revealed one linear range, from 0.27 to 0.48 mg L-1 (LOD of 0.04 mg L-1, R2 = 0.9960). Importantly, the proposed methodologies demonstrate satisfactory selectivity against potential interferences, with intra- and inter-day precision exhibiting low relative standard deviation (RSD) values. This study introduces a simple, sensitive, stable, selective, and sustainable electroanalytical method for the detection of NAR in pharmaceutical formulations, harnessing the advantages of unmodified electrodes and rigorous experimental validation.

Artemia salina Leach in photoprotection: A new model to evaluate the potential of nanoparticles for topical application

Using animals in research has generated heated debates around the world and in the scientific community. This fact, as well as the need to prove the safety and efficacy of pharmaceutical products, has led to a growing interest in the search for alternative methods. Given this scenario, developing new alternative methods has become vital, also including an economic perspective. Invertebrate models can be easily applied in research assays owing to their advantages, such as effortless handling, low cost, small size, and simple anatomy. Therefore, this study aimed to evaluate the use of the invertebrate microcrustacean Artemia salina Leach for phototoxicity and photoprotection assays. As a product model, solid lipid nanoparticles of the flavonoid rutin (SLNR) were produced, which shows several activities, focusing on antioxidant action. SLNR were obtained by the hot melt microemulsion technique using a high-shear homogenizer. These were characterized and evaluated for the average particle size (185 ± 12.19 nm), polydispersity index (0.140 ± 0.11), zeta potential (−34.04 ± 1.43 mV), and encapsulation efficiency (98.82 ± 0.37 %), representing satisfactory values for topical applications. Regarding the physicochemical characterization by thermal analysis, infrared spectroscopy by Fourier transform and X-ray diffraction results showed a decrease in the crystallinity of rutin. In the assay with Artemia salina, the lethal doses were determined against UVA radiation (LD50 = 133.2 ± 0.82 J/cm2) and UVB (LD50 = 0.45 ± 0.056 J/cm2). In the phototoxicity assay, the SLNR showed photochemopreventive action, mainly against UVA radiation. In photoprotection studies, formulations containing SLNR exhibited greater photoprotection against UVB radiation (86.60 % ± 7.64 viability) than UVA (58.00 % ± 10.95 viability). In conclusion, the method using Artemia salina L. proved to be a very effective and promising tool to evaluate the phototoxic and photoprotective potential of nanostructured systems.

Analysing Impurities and Degradation Products

In the realm of pharmaceutical analysis, the analysis of impurities and degradation products takes centre stage, and its significance cannot be overstated. These undesired substances can profoundly impact the quality, safety and efficacy of pharmaceutical products, necessitating rigorous analytical methods and processes at every stage of drug development and manufacturing. Forced degradation studies are instrumental in identifying and characterizing impurities that may arise within a product, a pivotal source of information for quality control and regulatory compliance. Stability testing is integral to the batch release process, ensuring each product batch meets established stability criteria before entering the market. Stability testing and degradation studies are indispensable constituents of pharmaceutical analysis. They substantially contribute to preserving the quality, safety, and efficacy of pharmaceutical products. Beyond their regulatory mandates, these studies serve as proactive instruments for comprehending and supervising product stability across their life cycles. The insights gleaned from these endeavours inform critical judgments during drug development and manufacturing, ultimately assuring the welfare of patients and compliance with stringent regulatory requisites.

Pharmacovigilance: Monitoring and Reporting Adverse Drug Reactions

Pharmacovigilance plays a pivotal role in ensuring the safety and efficacy of pharmaceutical products throughout their lifecycle. Monitoring and reporting adverse drug reactions (ADRs) are fundamental components of pharmacovigilance, aimed at identifying and minimizing risks associated with medication use. This paper provides an overview of the pharmacovigilance process, emphasizing the importance of robust ADR monitoring and reporting systems. It explores the various methods employed in pharmacovigilance, including spontaneous reporting, literature review, observational studies, and signal detection techniques. Additionally, the paper discusses the challenges and opportunities in ADR monitoring, such as underreporting, signal refinement, and the emergence of new data sources like social media and electronic health records. Strategies to enhance ADR reporting, including education and training initiatives for healthcare professionals and patients, as well as the utilization of advanced technology and data analytics, are also examined. Furthermore, the role of regulatory agencies, pharmaceutical companies, healthcare providers, and consumers in promoting pharmacovigilance efforts is highlighted.

Innate Immunity Modulating Impurities and the Immunotoxicity of Nanobiotechnology-Based Drug Products.

Innate immunity can be triggered by the presence of microbial antigens and other contaminants inadvertently introduced during the manufacture and purification of bionanopharmaceutical products. Activation of these innate immune responses, including cytokine secretion, complement, and immune cell activation, can result in unexpected and undesirable host immune responses. These innate modulators can also potentially stimulate the activation of adaptive immune responses, including the formation of anti-drug antibodies which can impact drug effectiveness. To prevent induction of these adverse responses, it is important to detect and quantify levels of these innate immunity modulating impurities (IIMIs) that may be present in drug products. However, while it is universally agreed that removal of IIMIs from drug products is crucial for patient safety and to prevent long-term immunogenicity, there is no single assay capable of directly detecting all potential IIMIs or indirectly quantifying downstream biomarkers. Additionally, there is a lack of agreement as to which of the many analytical assays currently employed should be standardized for general IIMI screening. Herein, we review the available literature to highlight cellular and molecular mechanisms underlying IIMI-mediated inflammation and its relevance to the safety and efficacy of pharmaceutical products. We further discuss methodologies used for direct and indirect IIMI identification and quantification.

Comparative study of updated Clinical Trial Regulations in India with respect to Australia, Europe, Japan and US

The national regulatory authorities, such as the US Food and Drug Administration (FDA), the European Medicines Agency (EMA), Central Drugs Standard Control Organization and the Australian Therapeutic Goods Administration (TGA), approve every drug that is prescribed for patients around the world. The process of approval undertaken by pharmaceutical companies for drug candidates consists of a series of phases to ensure the product is safe and effective at treating the disease.
 In this paper, we will compare the clinical trial regulations of India with respect to Australia, Europe, Japan & USA in order to determine the safety and efficacy of pharmaceutical products like drugs, biologics and medical devices in different geographical regions and to confirm the clinical trials studies follow strict scientific standards.

COMPARISON OF PHARMACISTS PROFESSIONAL ACTIVITY OF UKRAINIAN PHARMACY ON PROVISION OF INFORMATION ON ADVERSE REACTIONS OF PHARMACEUTICAL PRODUCTS

The aim of the research is the comparison of professional activity of pharmacists of pharmaceutical institution in Ukraine with different education level in relation to their responsibilities in detection and prevention of adverse reactions (AR) or lack of efficacy of pharmaceutical products (PP), set out in the regulatory documentation on this matter. Materials and methods. The questionnaire was developed and used for pharmacists of pharmaceutical institution, taken training on cycles of postgraduate education during 2016–2018. 70 higher education pharmacists (HEPs) and 80 specialized secondary education pharmacists (SSEP) were inquired. The integrity was evaluated by Fisher's ratio test (F). For convenience of calculation the corresponding functions of MS Excel were used. Results. The majority of SSEPs and HEPs of Ukrainian pharmaceutical institutions are aware of their duty to provide information on AR or lack of efficacy of pharmaceutical products to the Department of Post-authorization Supervision of the State Expert Center of the Ministry of Health of Ukraine and are aware of the regulatory legal documentation on this issue, however they are not active enough to take necessary action filling in the “Adverse drug reaction reporting form” and sending it to the national department. One of the reasons for the underactivity of pharmacy workers, irrespective of their level of education, is the low organization of this process in pharmacy institutions, in particular the absence of the “Adverse drug reaction reporting forms”. Conclusion. Higher education pharmacist are more self-acting in completing “Adverse drug reaction reporting forms” and are less likely to shift their responsibilities to the pharmacy manager. It is critical to resolve the issue on enhancement of efficiency of detecting AR and/or lack of efficacy of PP in pharmacy institutions of Ukraine is to improve the quality of organizational work of pharmacy managers.

Acquaintance, approach and application of pharmacovigilance: questionnaire based study at a tertiary care teaching hospital in Dhaka

Background: Pharmacovigilance is proven as an effective monitoring mechanism for safety and efficacy of pharmaceutical products with the assistance of physicians, pharmacists, nurses, and other healthcare professionals to avoid undue physical, mental and financial suffering of patients. Thus, this study was conducted to assess awareness of pharmacovigilance among the healthcare service providers to evaluate the acquaintance, approach application (3A) of judicial reporting of ADRs and pharmacovigilance in a tertiary care teaching hospital in Dhaka.Methods: A pre-tested questionnaire-based study was done among the 5th year medical students, interns, doctors and nurses of Holy Family Red Crescent Medical College, Dhaka, Bangladesh to assess the overall status of acquaintance (knowledge), approach (attitude) and application (practice) pharmacovigilance. Total 417 questionnaires were distributed and 389 were included as valid, compiled and analysed using SPSS version 25.0.Results: Among the respondents, almost 78% of the nurses responded the right answers and doctors responded the lowest 29% on average. The average percentage of approach and application of pharmacovigilance was low in all the respondent groups. The poorest outcome was observed about reporting an adverse drug reactions (ADR) form by all respondents as 01% to 08%.Conclusions: The overall status of pharmacovigilance in a tertiary teaching hospital was found paradoxically low, that revealed the necessity of much more initiatives at the undergraduate and postgraduate academic curriculum and intensive motivation, training, monitoring should be addressed to ensure the safety of medication, rationality of drug use and accomplish the national pharmacovigilance programs.

Oral product input to the GI tract: GIS an oral product performance technology

The patient receives a pharmaceutical product, not a drug. The pharmaceutical products are formulated with a drug, an active ingredient to produce the maximum therapeutic effect after oral absorption. Therefore, it is the product we must optimize for the patients. In order to assure the safety and efficacy of pharmaceutical products, we need an in vivo predictive tool for oral product performance in patients. Currently, we are a surprisingly long way from accomplishing that objective. If the 20th century was the ‘age of the drug’, i.e., the ‘magic bullet’, the 21st century must become the ‘age of the guided missile’, i.e., the delivery system, including the form of the active pharmaceutical ingredient (API) (‘drug’). The physical form of the drug and the delivery system must be optimized to maximize the therapeutic benefits of pharmaceutical products for humans. Oral immediate release (IR) dosage forms cannot be optimal for all drugs or likely even any drugs (APIs). Still, the formulation of pharmaceutical products has to be optimized for patients. But how do we optimize oral delivery of drugs? It is usually through ‘trial and error’, in humans! We need a better way to optimize the oral dosage forms. We have suggested to select different dissolution methodologies for this optimization based on BCS Subclasses. In this article, we present the predicted in vivo drug dissolution profile of ketoconazole as a model drug from our laboratory utilizing a gastrointestinal simulator (GIS), which is an adaptation of the ASD system. GIS consists of three chambers representing stomach, duodenum, and jejunum, to create the human gastrointestinal tract-like environment and enable the control the gastric emptying rate. This dissolution system allows the monitoring of the drug dissolution phenomena and the observation of the supersaturation and the precipitation of pharmaceutical products, which is useful information to predict in vivo dissolution of pharmaceutical products. This system can provide the actual input needed to accurately predict the input into the systemic circulation required by many of the absorption prediction packages available today.

Abstract 773: Optimizing drug regimens in oncology by clinical trial simulations: Why and how

Abstract Introduction: In therapeutic research, the safety and efficacy of pharmaceutical products are necessarily tested on humans via clinical trials after a very long and expensive development period. Alternative methodologies such as computer modeling and Clinical Trial Simulation (CTS) are a valuable option to reduce animal and human assays. The relevance of these methods is well recognized in pharmacokinetics and pharmacodynamics from the pre-clinical phase to post-marketing. However, they are seldom used and are poorly regarded for drug approval, despite FDA and EMA recommendations. We propose to discuss the principle behind, and the interest of, CTS approaches in drug development in oncology. Our work is based on a systematic review using two electronic literature databases (Medline and Web of Science). Key components of CTS: We will explain why and how to successfully develop CTS. Why developing CTS? To obtain a better knowledge of pharmacology and/or better prediction of safety and efficacy To evaluate disease progression dynamics and to test the potential impact of biomarkers To analyze subpopulations and extend the post-marketing authorization to help in the choice of the best outcome To optimize experimental designs in order to better anticipate the progress of the study How to develop CTS? CTS project must follow three steps: 1/The constitution of pharmacometricians team who elaborates clinical model and simulation plan that must contain three components: Input/output model: How do covariates impact outcomes? Covariate distribution Model: How can we generate virtual patients? Execution model: What can happen during the clinical trial? 2/Obtaining data for simulations. We will present the contribution of machine learning for CTS 3/The use of specialized software to realize simulations Limitations of CTS: We will present the features that can slow down or accelerate the development of CTS. The generalization of CTS could be greatly facilitated by the availability of software for modeling biological systems, by the clinical trials studies and hospital databases. Data-sharing and data-merging raise legal, policy and technical issues that will need to be addressed. CTS challenges and prospects: Development of future molecules will have to use CTS for faster development and thus enable better patient management. Drug activity modeling coupled with disease modeling, optimal use of medical data and increase of the computing speed should allow this leap forward. The realization of CTS requires not only the bioinformatics tools to allow interconnection and global integration of all clinical data, but also a universal legal framework to protect the privacy of every patient. CTS will have to be used to provide quantitative support for drug development decisions but will never replace real clinical trials. This in silico medicine opens the way to the 4P medicine: predictive, preventive, personalized and participatory. Citation Format: Jocelyn Gal, Gerard Milano, Julien Viotti, Renaud Schiappa, Audrey Dugue, Agnes Paquet, Sylvie Chabaud, Jean-Marc Ferrero, Emmanuel Chamorey. Optimizing drug regimens in oncology by clinical trial simulations: Why and how [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2017; 2017 Apr 1-5; Washington, DC. Philadelphia (PA): AACR; Cancer Res 2017;77(13 Suppl):Abstract nr 773. doi:10.1158/1538-7445.AM2017-773

Optimizing drug development in oncology by clinical trial simulation: Why and how?

In therapeutic research, the safety and efficacy of pharmaceutical products are necessarily tested on humans via clinical trials after an extensive and expensive preclinical development period. Methodologies such as computer modeling and clinical trial simulation (CTS) might represent a valuable option to reduce animal and human assays. The relevance of these methods is well recognized in pharmacokinetics and pharmacodynamics from the preclinical phase to postmarketing. However, they are barely used and are poorly regarded for drug approval, despite Food and Drug Administration and European Medicines Agency recommendations. The generalization of CTS could be greatly facilitated by the availability of software for modeling biological systems, by clinical trial studies and hospital databases. Data sharing and data merging raise legal, policy and technical issues that will need to be addressed. Development of future molecules will have to use CTS for faster development and thus enable better patient management. Drug activity modeling coupled with disease modeling, optimal use of medical data and increased computing speed should allow this leap forward. The realization of CTS requires not only bioinformatics tools to allow interconnection and global integration of all clinical data but also a universal legal framework to protect the privacy of every patient. While recognizing that CTS can never replace 'real-life' trials, they should be implemented in future drug development schemes to provide quantitative support for decision-making. This in silico medicine opens the way to the P4 medicine: predictive, preventive, personalized and participatory.

The ability of four strains of Streptococcus uberis to induce clinical mastitis after intramammary inoculation in lactating cows

AIM: To compare the ability of four strains of Streptococcus uberis at two doses to induce clinical mastitis in lactating dairy cows after intramammary inoculation in order to evaluate their usefulness for future experimental infection models.MATERIALS AND METHODS: Four field strains of S. uberis (26LB, S418, and S523 and SR115) were obtained from cows with clinical mastitis in the Wairarapa and Waikato regions of New Zealand. Twenty-four crossbred lactating cows, with no history of mastitis and absence of major pathogens following culture of milk samples, were randomly allocated to four groups (one per strain) of six cows. Each cow was infused (Day 0) in one quarter with approximately 104 cfu and in the contralateral quarter with approximately 106 cfu of the same strain. The other two quarters remained unchallenged. All four quarters were then inspected for signs of clinical mastitis, by palpation and observation of the foremilk, twice daily from Days 0–9, and composite milk samples were collected from Days 0–8 for analysis of somatic cell counts (SCC). Quarters were treated with penicillin when clinical mastitis was observed. Duplicate milk samples were collected and cultured on presentation of each clinical case and on Day 4 from challenged quarters with no clinical signs.RESULTS: Clinical mastitis was diagnosed in 26/48 (54%) challenged quarters. Challenge with strain S418 resulted in more cases of mastitis (12/12 quarters) than strains SR115 (7/12), 26LB (6/12) or S523 (1/12), and the mean interval from challenge to first diagnosis of mastitis was shorter for S418 than the other strains (p<0.001). The proportion of quarters from which S. uberis could be isolated after challenge was less for strain 26LB (1/6) than SR115 (6/7) (p<0.05), and SCC following challenge was lower for strain S523 than the other strains (p<0.05).CONCLUSIONS: There were significant differences between the strains in the proportion of quarters developing clinical mastitis, the interval to mastitis onset, SCC following challenge and the proportion of clinical cases from which S. uberis could be isolated. These results illustrate the difference in the ability of S. uberis strains to cause mastitis and the severity of the infections caused.CLINICAL RELEVANCE: Experimental challenge models can be used to compare infectivity and pathogenicity of different strains of mastitis-causing bacteria, the efficacy of pharmaceutical products and host-responses in a cost-effective manner.

Technical aspects on production of fluid extract from Brosimum gaudichaudii Trécul roots.

Instruction:Despite the increased use of Brosimum gaudichaudii roots as raw material on medicine to treatment of vitiligo, there are not studies that showing the impact of unit operations on the quality and standardized of the extract of B. gaudichaudii. The quality of the herbal extract is essential to ensure the safety and efficacy of pharmaceutical product. Due the medical and commercial importance, this study aimed to evaluate the impact of the extraction method (ultrasound or percolation) on the quality of herbal extract and optimize the extraction of psoralen and 8-methoxypsoralen (8-MOP) from B. gaudichaudii.Materials and Methods:The extraction recovery was evaluate by high-performance liquid chromatography (C8 reverse phase column and acetonitrile: Water 45:55 and flow rate 0.6 mL/min). The extraction was performed by ultrasound-assisted extraction (UEA) or percolation using a Box-Behnken design.Results:From both chemical markers (psoralen and bergapten), the optimal conditions for the UEA were an extraction time of 25 min, the mean particle size of 100 μm, and an ethanol: Water ratio of 55:45 (v/v).Conclusion:The extraction by percolation revealed that ethanol 55% was more efficient than ethanol 80% to extract psoralen and bergapten.

Comparative utilization of visual, potentiometric titrations and UV spectrophotometric methods in the determination of Ibuprofen.

The accuracy and reliability of the analytical results are critical in ensuring quality, safety, and efficacy of pharmaceutical products. However, to ensure these criteria, the choice of appropriate analytical method is required. This study sets out to compare the efficacy of visual, potentiometric titrations and UV spectrophotometric methods in the determination of the quality of Ibuprofen tablets in Nigeria. Eight different brands of Ibuprofen tablets were purchased from local pharmacies and drug stores. Visual, potentiometric titrations and UV spectrophotometric methods were utilized in the quantification of the different brands. The label claims of the various brands were assessed base on the different methods. The results obtained were compared with the official specification for uniformity. All the eight different brands of Ibuprofen tablets conform to the USP specification for the percent purity of the active principle using the visual titration, whilst one out of the eight brands did not conform to the USP specification with potentiometric titration as well as four out of the eight brands also, did not meet the official compendium specification using the UV spectrophotometric method. It can be inferred from this study that the choice of analytical method is critical in ascertaining the exact quality of pharmaceutical products.

Commentary on “Increasing Minority Participation in Clinical Research”: A White Paper from The Endocrine Society

Underrepresentation of racial and ethnic minorities in clinical research limits the applicability of trial results to diverse subpopulations. Recognizing an ongoing need to increase participation by minorities, The Endocrine Society established a task force of thought leaders from all stakeholder groups—the pharmaceutical industry, federal agencies, academia, and community groups—to develop a white paper outlining recommendations for meeting this need. The primary goal is to ensure that clinical research supporting the safety and efficacy of pharmaceutical products and the validity of biomarkers used to design therapeutic strategies is based on statistically powered data derived from minority subpopulations. To realize…

Analytical Validation of Potentiometric Method for Cetirizinium Ion

Accuracy and reliability of the analytical results are crucial for ensuring quality, safety, and efficacy of pharmaceutical products. However, to ensure these criteria, analytical validation is required. In this matter, many official documents describing the criteria of validation are available. However, these concern mainly chromatography analysis and bio‐analytical methods of pharmaceutical products, but they do not propose any experimental protocol for direct potentiometric methods using ion‐selective electrodes applied in pharmaceutical analysis. In this work, we are proposing a validation strategy based on the normative and regulatory guidelines applied to a potentiometric method with a polymeric membrane selective to cetirizine dihydrochloride. The statistical analysis obtained from raw data is described for all steps of this protocol. Also this validated method was successfully applied to the determination of cetirizine in pharmaceutical preparations using direct potentiometry with a mean relative standard deviation of 0.57% and a mean recovery of 99.63%.

Citizenship, Medical Expertise and the Capitalist Regulatory State in Europe

This article demonstrates how the concept of citizenship can be used to analyse the regulatory state, with particular reference to the safety and efficacy of pharmaceutical products in Western Europe. Empirical evidence on the citizenship dynamics of medicines regulation in Europe, which is drawn from documentary and interview data, is marshalled to interrogate theories of the decline in medical authority and `disorganized capitalism'. It is argued that late modernity has seen a pharmaceutical sector in which consumers have become more active and critically reflexive citizens, but the decline in producer power or in medical authority by the fracturing of expertise (or otherwise) has been minimal. It is concluded that the balance of evidence shows that the sector is highly organized, producer-driven, oligopolous and standardized, rather than disorganized, fragmented and flexible, despite consumers' growing activism and reflexivity.

Responsibilities, resources and results: Practicalities of testing in-house developed clinical software

Regulatory authorities place obligations on the producers of pharmaceutical computer software to ensure that it performs in the manner that it was designed to do. The reliability of data processed by computer systems is a key concern both for the regulatory authorities and pharmaceutical companies, which use it as evidence of the safety and efficacy of pharmaceutical products. Therefore, testing of software used in the pharmaceutical industry faces a tough challenge to satisfy the reliability criteria of its two customers: the regulatory authorities and the pharmaceutical company. Further challenges for software are posed by regulatory authorities, who see the widespread use of a particular computer system as a benefit. The more widely used and understood the software is, the lower the risk of unexpected failure and compromise of the data. Pharmaceutical companies, on the other hand, often wish to use innovative computer solutions which make the most of new technology and give performance improvements over other systems. An off-the-shelf word processing package presents a very low risk in the eyes of a regulatory authority. However, a one-off state-of-the-art computer system, especially if it is only used by one company, naturally demands a greater degree of control and scrutiny to ensure that the risk is contained.