Drug Samples Research Articles

Forensic Comparison of Amphetamine Chemical Profiles by Bayesian Predictive Modelling

ABSTRACTForensic chemists frequently employ statistical profiling approaches to assess the degree of similarity between samples of illicit drugs. Such profiling information can help reveal connections between nodes in distribution networks and manufacturing laboratories. For amphetamine, the routine method of comparing a pair of samples includes the use of a dissimilarity measure based on the Pearson correlation coefficient calculated between their chemical profiles obtained through gas chromatography–mass spectrometry. This simple measure of (dis)similarity has been shown distinguish pairs sharing a common origin (e.g., same production batch) to a reasonable level of accuracy. However, Pearson correlation fails to capture all the relevant notions of similarity between chemical profiles of amphetamine. We present a new statistical method for forensic drug comparison that uses a more sophisticated statistical modelling approach to determine similarity between samples. We show that this leads to improved performance over the correlation‐based approach. The proposed method is easily extendable and has an intuitive interpretation both from chemistry and forensic perspectives, which supports wide applicability to illicit drug profiling in practice.

UHPLC-QTOFMS Urine Drug Screening With Dilute-and-Shoot Sample Preparation and Vacuum-Insulated Probe-Heated Electrospray Ionization.

We developed a method for comprehensive urine drug screening by applying dilute-and-shoot extraction and vacuum-insulated probe-heated electrospray ionization with ultra-high performance liquid chromatography high-resolution quadrupole time-of-flight mass spectrometry (DS-UHPLC-VIP-HESI-QTOFMS). The method involved five-fold post-hydrolysis dilution of urine samples and chromatography on a C18 UHPLC column prior to QTOFMS analysis. The recently introduced VIP-HESI ion source was chosen due to its enhanced ionization efficiency and compatibility with UHPLC-QTOFMS. Extensive data was acquired in positive ion mode with a low collision energy (7 eV) and an elevated collision energy (30 eV), using the broadband collision-induced dissociation data acquisition scan mode that continuously generated high-resolution and accurate mass for parent and fragment qualifier ions, and parent ion isotopic patterns. Compound identification was performed against an in-house database with 1263 compound entries, using an automated post-run reverse target database search with preset identification criteria. Method validation with 56 different drugs showed acceptable results for the limit of identification (median 5 ng/mL), matrix effects (70-130%), repeatability of retention times (< 1%), mass accuracy (< 1 mDa), as well as for specificity and stability. As compared with an established UHPLC-QTOFMS method relying on solid-phase extraction and conventional electrospray ionization, DS-UHPLC-VIP-HESI-QTOFMS produced comparable results from authentic clinical urine samples for most drugs, but showed clearly improved detectability for pregabalin, gabapentin, and ritalinic acid. We anticipate that the new method will be a step forward for laboratories performing routine urine drug screening due to its fast turnaround time, reduced manual workload, cost efficiency, and broad substance coverage.

Temporal and spatial trends of fentanyl co-occurrence in the illicit drug supply in the United States: a serial cross-sectional analysis

BackgroundFentanyl and its analogs contribute substantially to drug overdose deaths in the United States. There is concern that people using drugs are being unknowingly exposed to fentanyl, increasing their risk of overdose death. This study examines temporal trends and spatial variations in the co-occurrence of fentanyl with other seized drugs. MethodsWe identified fentanyl co-occurrence (the proportion of samples of non-fentanyl substances that also contain fentanyl) among 9 substances or substance classes of interest: methamphetamine, cannabis, cocaine, heroin, club drugs, hallucinogens, and prescription opioids, stimulants, and benzodiazepines. We used serial cross-sectional data on drug reports across 50 states and the District of Columbia from the National Forensic Laboratory Information System, the largest available database on the U.S. illicit drug supply, from January 2013 to December 2023. FindingsWe analyzed data from 11,940,207 samples. Fentanyl co-occurrence with all examined substances increased monotonically over time (Mann-Kendall p<0.0001). Nationally, fentanyl co-occurrence was highest among heroin samples (approx. 50%), but relatively low among methamphetamine (≤1%), cocaine (≤4%), and other drug samples. However, co-occurrence rates have grown to over 10% for cocaine and methamphetamine in several Northeast states in 2017-2023. InterpretationFentanyl co-occurs most commonly with heroin, but its presence in stimulant supplies is increasing in some areas, where it may pose a disproportionately high risk of overdose. FundingThis work was partly supported by FDA grant U01FD00745501. This article reflects the views of the authors and does not represent the views or policies of the FDA or US Department of Health and Human Services.

Beyond the Arbitrariness of Drug-Likeness Rules: Rough Set Theory and Decision Rules in the Service of Drug Design

Lipinski’s Rule of Five and Ghose filter are empirical guidelines for evaluating the drug-likeness of a compound, suggesting that orally active drugs typically fall within specific ranges for molecular descriptors such as hydrogen bond donors and acceptors, weight, and lipophilicity. We revisit these practices and offer a more analytical perspective using the Dominance-based Rough Set Approach (DRSA). By analyzing representative samples of drug and non-drug molecules and focusing on the same molecular descriptors, we derived decision rules capable of distinguishing between these two classes systematically and reproducibly. This way, we reduced human bias and enabled efficient knowledge extraction from available data. The performance of the DRSA model was rigorously validated against traditional rules and available machine learning (ML) approaches, showing a significant improvement over empirical rules while achieving comparable predictive accuracy to more complex ML methods. Our rules remain simple and interpretable while being characterized by high sensitivity and specificity.

How promotion mix helps sustain brand sales during market transitions: insights from the pharmaceutical industry

Purpose Pharmaceutical marketers use detailing, sampling and direct-to-consumer advertising (DTCA) to promote a branded prescription drug (brand drug) to health-care professionals and consumers. These promotion mix elements help raise brand awareness, increase prescription likelihood and guard a product market against competing brand drugs. However, the extent to which these elements remain effective when a brand drug goes off patent and its marketing exclusivity expires, allowing low-price generics to enter the market, remains unclear. This study aims to explore the effectiveness of promotion mix elements before and after the market entry of a generic drug. Design/methodology/approach The authors collected and analyzed a panel data set of 41 brand drugs from 7 therapeutic classes between 2007 and 2014 (3,201 observations) using the two-stage control function approach to address potential endogeneity. Findings The effectiveness of promotion mix elements changes significantly, but not in a universally uniform way, during a market transition. Detailing and DTCA are increasingly effective after a brand drug’s generics enter the market. In contrast, sampling is more effective before the market transition. The positive effects of sampling on brand sales are stronger when the price of a brand drug is higher than the average price of its competing brands. Sampling also helps amplify the positive influences of detailing and DTCA on brand sales. Research limitations/implications This study shows that pharmaceutical promotion is not equally effective in the brand drug market with/without generic competitors. Detailing and DTCA are increasingly effective when generic competition intensifies. In contrast, the distribution of free drug samples is less effective after more generic drugs enter the market. Practical implications Incumbent brands’ promotion expenditures often drop dramatically when the expiration of their patents is near, a practice that likely continues after generics enter the market. Taking into consideration these industry norms and their findings, the authors suggest that promotional decisions during a market transition should not overly focus on cutting promotional expenditures across the board. Since a firm’s promotional expenditure tends to be expensive, factoring in information on the effectiveness of each promotion mix element helps marketers make well-informed strategic decisions on resource allocation during the transition from a market without generics to a market with generics. Originality/value Previous studies do not explicitly account for structural changes in the brand drug market over time. However, the expiration of patent and marketing exclusivity marks a transitional period in which a brand drug eventually competes with its generic counterparts. Given the criticality of such structural change, the authors examine brand drugs’ promotion effectiveness in the presence of their generic counterparts.

Developing a New Method for the Estimation of Valsartan (VST) in Pharmaceutical Dosage Samples by Using Diazotization and Coupling Reactions Spectrophotometrically

Introduction: A new method for valsartan (VST) estimation in pharmaceutical dosage samples by spectrophotometry was developed. Method: The method was based on the formation of coloured dye by the diazotization reaction of 3-amino-2-naphthol with sodium nitrite in an acidic medium to form diazonium compounds, which were then coupled with VST in a basic medium. Results: The drug sample showed linearity in the range 4.6 - 24.2 μgmL-1, and the λmax was found at 432nm. Sandell’s sensitivity (9.950×10-3), Molar absorbtivity (Ɛ= 4.377×104), regression equa-tion (y= 0.0775x + 0.0041), correlation coefficient (r2= 0.968), detection limit (DL= 0.668) and quantitation limit (QL= 2.024) were evaluated. Conclusion: The percentage recovery of the drug samples was found to be 100%. This method successfully determined VST in Pharmaceutical dosage samples.

Comprehensive Analysis of Sulfated Flavonoids in Eclipta prostrata for Quality Evaluation

Eclipta prostrata (Asteraceae) is employed as a hemostatic agent in many traditional medicines, owing to its sulfated flavonoid content. In this study, we obtained crude drug samples from three provinces collected in different years and analyzed their sulfated flavonoid contents using liquid chromatography–mass spectrometry (LC–MS) for quality evaluation. Because sulfated flavonoids are unstable and difficult to isolate from extracts, this study first synthesized a variety of sulfated flavonoids and accumulated spectral data in order to identify the compounds in E. prostrata. The LC–MS analysis of six crude drug samples revealed the presence of luteolin 7-sulfate, apigenin 7-sulfate, diosmetin 7-sulfate, and diosmetin 3′-sulfate. The samples without luteolin 3′-sulfate featured high apigenin 7-sulfate content. Although the samples were collected from the same locality, their compositions differed depending on the year of collection. Further, they were classified according to three patterns: (1) samples with luteolin 7-sulfate as the main component, (2) samples with apigenin 7-sulfate as the main component, and (3) samples with relatively high diosmetin sulfate content. Luteolin 7-sulfate typically exhibits relatively high erythrocyte aggregation efficiency and fibrinogen aggregation rate. These results demonstrate that the analysis of sulfated flavonoids is beneficial for the quality evaluation of E. prostrata for hemostatic applications.

Advances in the application of liquid chromatography tandem mass spectrometry for therapeutic drug monitoring

Therapeutic drug monitoring is a good interpretation of personalized medicine, which helps to improve the safety and effectiveness of patient medication. Liquid chromatography-tandem mass spectrometry (LC-MS/MS) has gradually been widely accepted by clinical laboratories due to its characteristics of specificity, sensitivity, and flexibility in method development. This article introduces the importance and analytical techniques for therapeutic drug monitoring, describes the application and development of liquid chromatography tandem mass spectrometry for therapeutic drug monitoring, new advances in the detection of different drug types and sample types, and challenges in automation, convenience, and standardization.

Excitation energy transfer based naphthalimide-boron-dipyrromethene dyads as two-photon fluorescent probes for palladium(0) detection and live cell imaging

Increasing industrial demand has accelerated the consumption and contamination of palladium (Pd) worldwide. The implementation of fluorescent probes, especially with two-photon excitation, holds great promise for Pd detection in environmental and biological analysis. In this work, two naphthalimide (NPI)-boron-dipyrromethene (BDP) dyads (named NBH and NBN) were developed as two-photon fluorescent probes for Pd(0) detection based on an excitation energy transfer (EET) strategy, employing NPI as the energy donor and BDP as the acceptor. Spectroscopic studies revealed that both probes exhibited a fast response to Pd(0) in a pronounced fluorescence "ON-OFF" manner. The Pd-catalyzed Tsuji-Trost reaction activated an intramolecular photoinduced electron transfer (PET) process between the aniline and BDP moieties, resulting in the fluorescence quenching of the BDP fluorophore. The reaction-based probes exhibited excellent sensitivity and selectivity for Pd(0) species with a detection limit as low as 2.4 nM. These probes were successfully applied to the determination of Pd residues in drug, soil, and water samples. A simple smartphone-based platform was also constructed to determine Pd(0) via an RGB reader. With negligible cytotoxicity, confocal imaging study validated their feasibility of monitoring Pd(0) in living cells through multiple excitation channels.

Drug Samples in Dermatology: A focus on underserved and under-resourced patients

Drug Samples in Dermatology: A focus on underserved and under-resourced patients

TiO2 intercalated MWCNTs nanocomposite sensor for the detection and quantification of 5-Fluorouracil

The present analysis deals with the fabrication of novel electrochemical sensing platforms for the determination of the anti-cancer drug 5-Fluorouracil (5-FLU). Multiwalled carbon nanotubes/titanium dioxide nanoparticles (TiO2·MWCNTs) modified carbon paste electrodes were constructed and used to quantify 5-FLU in pH 7.0. TiO2·MWCNTs nanocomposite reveals a non-uniform distribution of agglomerated TiO2 nanoparticles over the smooth surface of MWCNTs At the TiO2∙MWCNTs/CPE, the 5-FLU molecule underwent an irreversible electro-oxidation process. The proposed electrode platform exhibited a high catalytic effect for the 5-FLU. The TiO2∙MWCNTs/CPE sensor shows the detection limits of 2.7nM for 5-FLU with sensitivity of 82.15µA·µM−1·cm−2. The sensor was employed to detect the desired drug moiety in the urine samples of pharmaceutical drugs along with spiked water and soil samples; the good recovery values demonstrating the applicability and selectivity of the sensor were supported by excipient interference investigation. Thus, the developed sensors and method makes them a promising alternative for future research to determine other bio-active molecules in pharmaceutical and clinical samples.

Supramolecular Solvent Liquid Phase Microextraction of Voriconazole İn Pharmaceutical and Environmental Samples With High Performance Liquid Chromatography Detection

In this study, a new analytical method based on the supramolecular solvent liquid phase microextraction (Ss-LPME) and HPLC was developed for the analysis of voriconazole as an active drug in the class of antifungals with a wide spectrum of action at trace levels. Nano/micro sized supramolecular phase formed in 1-decanol, tetrahydrofuran and aqueous environment was used as extraction agent for separation and preconcentration of trace level of voriconazole. For the optimization of the Ss-LPME method, important analytical parameters such as the effect of sample solution pH, volume of 1-decanol, amount of THF, ultrasounic irridation time, centrifugation time and sample solution volume on the extraction efficiency were evaluated. Optimal conditions of the Ss-LPME; pH: 8, 1-decanol volume: 200 µL, THF volume: 300 µL, ultrasounic irridation time:10 min and centrifugation time: 8 min. For the developed Ss-LPME/HPLC procedure, the limit of detection (LOD), limit of quantification (LOQ) and enhancement factor (EF) were found 2.7 µg·L-1, 8.8 µg·L-1 and 36, respectively. The Ss-LPME/HPLC procedure was applied to waste water, lake water and drug samples. The fact that recovery values ranging from 100% to 108.5% were obtained for these real samples proved that this method can be used successfully in the matrix environments studied

Investigation of the chemical and biological composition of the medicinal plant juzgun leucocladum-for further production of an antibacterial veterinary drug

Juzgun (лат. Calligonum) is a genus of perennial deciduous branching shrubs from the Buckwheat family (лат. Polygonaceae). According to some data, up to 158 plants are included in the genus, but since the genus is poorly studied, the definition of the species included in it is considered inaccurate. Moreover, some scientists claim that it is impossible because of multiple morphological differences that do not have geographical certainty. Tannins, citric and phenolic carboxylic acids, alkaloids, leucoanthocyanidins, flavonoids were found in the chemical composition of plants from the genus Juzgun. Plants from the genus Juzgun can potentially serve as a source of medicinal raw materials. Scientists have found phenolcarbonic acids in them, which have a choleretic effect, acting as a hypotensive agent. Antitumor effect is endowed not only with the leucoanthocyanidins present in the representatives of the genus, but also a number of flavonoids.We have investigated the chemical composition and identification of biologically active compounds in the vegetable raw materials of the Juzgun leucocladum. Physico-chemical studies have been carried out. The elemental composition of raw materials has been determined.The morphology of the raw materials was investigated, and the amino acid composition of the raw materials was also determined. The first samples of a veterinary drug based on Juzgun plant raw materials and phytosorbents for veterinary purposes were obtained and sent for clinical research.

Laser‐scribed graphene toward scalable fabrication of electrochemical paper-based devices for lidocaine detection in forensic and pharmaceutical samples

Lidocaine (LID), a tertiary amine drug, is widely used as a local anesthetic for topical anesthesia and also presents antiarrhythmic and analgesic properties. Given its use can induce a temporary loss of sensory, motor, and autonomic function, it has been associated with criminal instances of drug-facilitated sexual assault. Herein, we manufactured an electrochemical paper-based analytical device (ePAD) using the laser-scribed graphene (LSG) technique for LID detection in pharmaceutical and forensic applications. The paper-based devices were characterized by scanning electron microscopy (SEM) and Raman spectroscopy, confirming the porosity and graphene-derived nature of the LSG material. In addition, to enhance the electrocatalytic properties, the LSG electrode was modified with a nanocomposite based on the mixture of multi-walled carbon nanotubes (MWCNT) and poly(3,4-ethylenedioxythiophene) polystyrene sulfonate (PEDOT:PSS). Electrochemical characterizations of the non-modified and MWCNT/PEDOT:PSS-modified electrodes by impedance spectroscopy (EIS), cyclic voltammetry (CV), and differential pulse voltammetry (DPV), revealed the enhancement of the electrochemical properties of the modified electrode, providing higher detectability for LID detection. An analytical curve was built using DPV technique and exhibited a linear response in the concentration range of 31 to 248 µmol L−1 LID. The limits of detection (LOD) and quantification (LOQ) of the method were 0.72 µmol L−1 and 2.39 µmol L−1, respectively. The manufacturing reproducibility of the method was assessed by testing 8 sensors from different batches and provided a relative standard deviation (RSD) of 4.92 % (n = 8). The developed sensor was applied to LID determination in a commercial anesthetic sample and, as proof of the applicability of potential use in crime scenes of drug-facilitating crimes, we analyzed spiked LID in alcoholic drinks (vodka and tequila samples). The recovery percentages ranged from 79 % to 109 %, highlighting the practical use of our portable method for in-field analysis. In addition, four seized cocaine samples containing LID were successfully analyzed to demonstrate the potential use as a LID screening tool in street drug samples.

Novel drug sampling technique: portal vein catheterization in steers.

To determine the feasibility of catheterizing the portal vein to obtain serial portal vein blood samples in steers. We hypothesized that the portal vein catheterization would be a successful continuous sampling technique with minimal adverse effects in steers. 2 groups of steers were used: a pilot group (n = 2) and experimental group (n = 6). In both groups, steers were sedated with xylazine. The right rib spaces were clipped and aseptically prepped. The portal vein was visualized via ultrasound, and a 14-gauge catheter was placed percutaneously and advanced into the portal vein. A guide wire was passed through the catheter, followed by a tissue dilator and then a vascular balloon catheter. In the pilot group, blood chemistries were performed prior to portal vein catheterization and then again once the catheter was placed (with samples from both the jugular vein and portal catheter). The liver was also examined at necropsy for any gross lesions in both groups. All steers tolerated the portal vein catheters well, with the catheters lasting for the full length of the study period (7 days). The only observed adverse reaction was a superficial abscess at the catheter site (n = 3). On necropsy, 1 liver had gross discoloration, but no other abnormalities were noted. There were no significant changes in biochemistry profiles before or after portal vein catheterization. Portal vein catheterization is a novel and feasible serial sampling technique of the portal vein. This technique can be used in future pharmacokinetic, nutrition, metabolism, or toxicity studies.

Emergence of semi-synthetic cannabinoids in cannabis products seized in Eastern Denmark over a 6-year period.

Semi-synthetic cannabinoids (SSCs) are derivatives of phytocannabinoids with slight chemical modifications. SSCs have appeared as legal alternatives to tetrahydrocannabinol (Δ9-THC) in recent years. This study investigates the prevalence of SSCs in seized drug samples from Danish police and custom authorities seized in Eastern Denmark in the period 2018-2023. Screening data obtained by gas chromatography-mass spectrometry (GC-MS) were reprocessed to enable detection of SSCs. Seized drug samples were categorized into six types of formulations. Δ8-THC was the first SSC observed and appeared in 2019 followed by hexahydrocannabinol (HHC), tetrahydrocannabidiol (H4-CBD), hexahydrocannabinol acetate (HHC-O-Acetate), hexahydrocannabiphorol (HHCP) and tetrahydrocannabiphorol (Δ9-THCP). Only one sample positive for SSCs was observed before the third quarter of 2021, with positive samples increasing from third quarter of 2022. Over the study period, a total of 15% (n = 216) of seized cannabis products were positive for SSCs. HHC was the most frequently identified SSC and found in 10% (n = 137) of samples, followed by H4-CBD at 4% (n = 53), Δ8-THC at 3% (n = 44), and HHC-O-Acetate, HHCP, and THCP each at 1% (n = 10-20). SSCs appeared in 56% of E-cigarette products, 20% of hashish, 17% of concentrates, 10% of edibles, and 10% of plant materials. In conclusion, SSCs represent a new type of cannabinoids with a rapidly growing popularity and with specific compounds dominating at different periods. Some of the observed trends were likely influenced by the scheduling of HHC in May of 2023 in Denmark.

Comparative Chemical Study of Three Different Market Samples of an Important Clay Mineral Drug “Gil-E-Makhtum” with A Brief Ancient Description of Earth's Natural Resources

The medical use of earth's natural resources or mineral drugs is probably as old as the history of man kinds and has been used widely for the ailments of many diseases despite knowing the presence of chemical constituents or pharmacological activities of that particular substance but in the present era, with the modern techniques much more research work has been done to know the active components and their pharmacological properties which could have now been used in the modern medicine. Among the various earth natural resources or mineral drugs Gil-e-Makhtum (Sealed earth or the type of clay) also known by the name Lemnian earth, is a medicine in the shape of a stamped clay tablet (Sphragis) from Lemons, northeastern Greece, was much valued in antiquity and is utilized as such as well as an ingredient in the number of compound formulations in the Unani system of medicine for the treatment of various diseases. In this paper with the description of the brief history of Earth’s Natural Resources, the comparative chemical study of three different market samples of Gil-e-Makhtum was carried out by following some parameters of qualitative analysis and quantitative estimations. The analysis included Loss of weight on drying at 105oC, solubility in 1 normal hydrochloric acid and water, total ash, acid insoluble ash, bulk density, and tapped density. Besides, some major estimations e. g. Hematite (Fe2O3), Alum (Al2O3), Quartz (SiO2), and Calcium oxide (CaO) were also carried out.

Determination of bioequivalence between generic and reference drugs using laser-induced breakdown spectroscopy

BackgroundIn vitro bioequivalence studies are strictly limited to the comparison of dissolution performance to a reference drug. These studies are performed without considering the chemical similarity between the generic and reference drug formulations. This work has focused on developing a groundbreaking method based on the laser-induced breakdown spectroscopy (LIBS) technique for the in vitro bioequivalence determination of immediate-release solid oral dosage form generic drugs and as an alternative method for establishing the biowaiver of in vivo generic drug studies. ResultsThe novel LIBS-based methodology to determine in vitro bioequivalence is fast, easy to perform, and can be carried out without the requirement of tedious and complicated sample pre-treatment, nor expensive instrumentals and reagents, almost directly on the drug samples. Furthermore, the proposed methodology demonstrated that it is enough to identify the spectrochemical similarity of the formulation between generic drugs to a reference drug through the chemometric study of their LIBS spectra, based on the determination of the differentiation and similarity factors, f1 and f2, respectively, used in the pharmaceutical industry in this purpose. After analysing their LIBS spectra, the generic drugs selected for this work have all been shown to be in vitro bioequivalent, given their f1 values of less than 15 and f2 values greater than 50, according to the technical regulations on which the American and European medicines agencies are based for the approval of registration for generic immediate-release solid oral dosage form drugs. This has been evidenced even for drugs from Class III and Class IV of the biopharmaceutical classification system, whose active principle nominal concentration is very low as 0.1 and 0.25 mg/tablet, respectively. Significancefor the first time the LIBS technique has been successfully used in an advanced application for the pharmaceutical industry. The proposed method constitutes a reliable and specialized methodology for the establishment of formulation similarity between two drugs, without the requirement of separate identification of each of their components, which is a new and potential tool to determine the in vitro bioequivalence for generic immediate-release solid oral dosage form drugs.

On-site monitoring of L-adrenaline neurotransmitter in biological samples by chitosan oligosaccharide derived carbon dots

Carbon quantum dots (CDs) are fascinating fluorescent nanomaterial for spectrofluorimetry sensor applications, owing to the fact of its strong chemical stability, high quantum yield and high photostability. At this instance, we have developed the fluorescent sensing technique to detect the L-adrenaline (L-Adr) by nitrogen-doped carbon quantum dots as a sensing probe. The nitrogen-doped carbon dots was synthesized using chitosan oligosaccharide by hydrothermal method. The synthesized chitosan oligosaccharide derived CDs (COL-CDs) exhibits blue fluorescence under UV light and the size of the carbon quantum dots is 3.39 ± 0.08 nm calculated from HR-TEM image. The hormone called L-Adr found in the human body is crucial for controlling visceral processes. Utilizing the process of photo-induced electron transfer (PET), the previously mentioned COL-CDs have applied to sense the L-Adr. The sensing mechanism have explained clearly using Rehm-Weller equation by calculating ΔG. Tap water, blood serum, urine and adrenaline drug samples employed as real sample for the sensing L-Adr. A reagent free paper-based kit established for the purpose of on-site monitoring L-Adr. The smartphone’s colour picker software used to measure the RGB intensity from the paper-based kit.

Pharmaceutical innovativeness index: methodological approach for assessing the value of medicines – a case study of oncology drugs

ABSTRACT Background We propose a framework to assess the value of pharmaceutical innovations, with explicit clinical and methodological parameters, based on the therapeutic value and health needs. Research design and methods The study was based on the adaptation of health technology assessment methods documented in the literature, which was applied to a sample of oncological drugs. Difficulties and issues during the application of those tools were identified and addressed to develop a new framework with new and revised domains and clear classification criterion for each domain. Scores were assigned to each level and domain according to their relevance to generate the final score of innovativeness. Results The Pharmaceutical Innovation Index (PII) includes four domains, two related to clinical and social dimensions – Therapeutic Need and Added Therapeutic Value – and other two about methodological features – Study Design and Quality (risk of bias). The scores combined after assigned to each domain results Index of the Innovativeness of the medicines represents the degree of pharmaceutical innovation. Conclusion This work proposes a transparent methodology with well-defined criteria and script; the algorithm developed with authors’ weightings and criteria may be switched to best adjust to other applications, perspective or clinical indications, while keeping the transparency and objectiveness.