Over the last three to four decades, Therapeutic Drug Monitoring (TDM) has shaped itself as therapeutic drug management, an integral component of precision medicine. The practice of TDM is not ...extensive in India, despite being one of the fastest-growing economies in the world. It is currently limited to a few academic medical centres and teaching hospitals. Apart from the immunosuppressive drugs, several other therapeutic areas, such as anticancer, antifungal, antibiotic and antitubercular, have demonstrated great potential to improve patient outcomes in Indian settings. Factors such as the higher prevalence of nutritional deficiencies, tropical diseases, widespread use of alternative medicines, unalike pharmacogenomics and sparse population-specific data available on therapeutic ranges of several drugs make the population of this subcontinent unique regarding the relevance of TDM. Despite the impact of TDM in clinical science and its widespread application, TDM has failed to receive the attention it deserves in India. This review intends to bring out a strength, weakness, opportunity and threats (SWOT) analysis for TDM in India so that appropriate steps for fostering the growth of TDM could be envisioned. The need of the hour is the creation of a cooperative group including all the stakeholders, such as TDM professionals, clinicians and the government and devising a National Action Plan to strengthen TDM. Nodal TDM centres should be established, and pilot programmes should be rolled out to identify the thrust areas for TDM in the country, capacity building and creating awareness to integrate TDM into mainstream clinical medicine.
About the Authors: Monique Couderc-Pétry Affiliation: Pétry Medical Consulting, Suresnes, France Elisabeth Eléfant Affiliation: Reference Center on Teratogenic Agents (CRAT), Armand-Trousseau ...Hospital, Paris, France Monique Wasunna Affiliation: Drugs for Neglected Diseases initiative, Nairobi, Kenya Alwyn Mwinga Affiliation: Zambia AIDS Related Tuberculosis Project (Zambart), Lusaka, Zambia Nilima A. Kshirsagar Affiliation: Clinical Pharmacology, Indian Council of Medical Research, New Delhi, India Nathalie Strub-Wourgaft * E-mail: nstrub@dndi.org Affiliation: Drugs for Neglected Diseases initiative, Geneva, Switzerland Citation: Couderc-Pétry M, Eléfant E, Wasunna M, Mwinga A, Kshirsagar NA, Strub-Wourgaft N (2020) Inclusion of women susceptible to and becoming pregnant in preregistration clinical trials in low- and middle-income countries: A proposal for neglected tropical diseases. DNDi’s R&D pipeline encompasses a full range of drug development, from early research and preclinical through to phase I, II, and III clinical trials for diseases such as African sleeping sickness, leishmaniasis, Chagas disease, filarial diseases, and mycetoma and also for neglected patients such as those with pediatric HIV and hepatitis C. DNDi’s goal is to obtain regulatory approval based on robust data in all population subsets who need such treatments. ...the risk of unexpected pregnancy in a WoSuP during a clinical trial in a LMIC is particularly high. Since DNDi aims to develop treatments that can be rolled out to a large community, documenting the conditions under which the benefit and risk balance of new treatments may and should be studied in young women is essential.
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DOBA, IZUM, KILJ, NUK, PILJ, PNG, SAZU, SIK, UILJ, UKNU, UL, UM, UPUK
Pain is one of the critical health issues in the world. While almost everyone experiences acute pain at some point, around 27.5% of the population suffer from its more persistent and chronic form. ...The current medication regimen is yet to meet expectations and provides suboptimal treatment. Cocrystals are solid forms in which two or more chemically distinct molecules are present in a single crystal lattice. Co‐crystallization offers solutions to the limitations of many drugs in pain treatment. Drug–drug cocrystals (DDC) improve the physicochemical properties of their components and offer a chance to use the synergistic effects of multimodal therapy. DDC have been widely investigated in the field of pain management. Literature on DDC reports improvement in physicochemical properties such as hygroscopicity, solubility, bioavailability, stability, and compressibility. DDC have attracted many researchers, and as a result, a drug product containing cocrystals of tramadol hydrochloride and celecoxib has been successfully commercialized in the United States. Further, one more multidrug cocrystal for pain management has entered advanced clinical trials. This review discusses the applications of DDC in pain management.
Multimodal analgesia is the preferred treatment for pain when a single effective drug is unavailable. Drug–drug cocrystals (DDC) are adequate to improve physicochemical and pharmacological properties. DDC can help achieve faster analgesia even at reduced doses or enhance the efficacy of the current analgesics. The first commercial DDC for pain has been approved for marketing, promoting considerable attention to the field.
Dry eye syndrome (DES) is a common disorder with rising incidence due to increased use of digital devices. While multiple treatment options are available, some are not efficacious or sometimes even ...safe for use in DES. This is particularly true for Fixed Dose Combinations (FDCs) that may contain ingredients having no rational for their use or may actually be harmful. Various committees appointed by the Government have reviewed several FDCs marketed in India and found some of them to be irrational and recommended for their removal. This paper discusses the contents of some of these FDCs marketed for DES with an aim to ensure that prescribers are mindful of their ingredients and whether there is adequate data about their efficacy and safety and prescribe them only if they consider them necessary for managing the patient.
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In this work we report the realization of the first low-threshold cryogenic detector that uses diamond as absorber for astroparticle physics applications. We tested two 0.175 g CVD diamond samples, ...each instrumented with a W-TES. The sensors showed transitions at about 25 mK. We present the performance of the diamond detectors and we highlight the best performing one, where we obtained an energy threshold as low as 16.8 eV. This promising result lays the foundation for the use of diamond for different fields of applications where low threshold and excellent energy resolution are required, as i.e. light dark matter searches and BSM physics with coherent elastic neutrino nucleus scattering.
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More specifically, supply-side reforms such as compulsory price cuts, measures to lower generics prices, reference pricing in a class and delisting cost-ineffective drugs and demand side reforms such ...as academic detailing, prescribing guidance with electronic prescribing support system, prescribing targets, financial incentives to enhance substitution and to generic drugs can improve prescribing efficiency 10. The government has taken initiatives such as centralized procurement (as in Delhi, Rajasthan and Tamil Nadu States in India), strengthening drug and food regulatory system with new drug testing laboratories in States to assure quality of medicines, drug price control of essential medicines and use of generics (costs half to one tenth of branded drugs) to ensure access to quality medicine. ...this causes increase in cost. ...there is a conflict between private gain and freedom, and societal need and social costs. Collaborative research on low-cost treatment, standards for generics, biosimilars and drug delivery systems, appropriate price control, innovative interventions and strategies to reduce irrational use would be additional long-term activities that will promote rational use of drugs and reduce their cost.
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Experimental models show a male bias in murine malaria; however, extant literature on biases in human clinical malaria is inconclusive. Studies in hyperendemic areas document an absence of sexual ...dimorphism in clinical malaria. Data on sex bias in clinical malaria in hypoendemic areas is ambiguous--some reports note a male bias but do not investigate the role of differential mosquito exposure in that bias. Moreover, these studies do not examine whether the bias is age related. This study investigates whether clinical malaria in hypoendemic regions exhibits a sex bias and whether this bias is age-dependent. We also consider the role of vector exposure in this bias.
Retrospective passive clinical malaria datasets (2002-2007) and active surveillance datasets (2000-2009) were captured for the hypoendemic Mumbai region in Western India. To validate findings, passive retrospective data was captured from a primary malaria clinic (2006-2007) in hypoendemic Rourkela (Eastern India). Data was normalized by determining percent slide-positivity rates (SPRs) for males and females, and parasite-positivity distributions were established across age groups. The Mann-Whitney test, Wilcoxon Signed Rank test, and Chi-square analysis were used to determine statistical significances.
In both the Mumbai and Rourkela regions, clinical malaria exhibited an adult male bias (p<0.01). A sex bias was not observed in children aged ≤10. Post-puberty, male SPRs were significantly greater than females SPRs (p<0.01). This adult male bias was observed for both vivax and falciparum clinical disease. Analysis of active surveillance data did not reveal an age or sex bias in the frequency of parasite positivity.
This study demonstrates an age-dependent sex bias in clinical malaria in hypoendemic regions and enhanced incidence of clinical malaria in males following puberty. Possible roles of sex hormones, vector exposure, co-infections, and other factors in this enhanced susceptibility are discussed.
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Context: An oral dosage form containing floating bioadhesive gastroretentive microspheres forms a stomach-specific drug delivery system for the treatment of Helicobacter pylori.
Objectives: To ...prepare and evaluate controlled release floating bioadhesive gastroretentive chitosan-coated amoxicillin trihydrate-loaded Caesalpinia pulcherrima galactomannan (CPG)-alginate beads (CCA-CPG-A), for H. pylori eradication.
Materials and methods: CCA-CPG-A beads were prepared by ionotropic gelation, using 2
3
factorial design with quantity of drug, combination of CPG with sodium alginate and concentration of calcium chloride as variables. Beads facilitated mucoadhesion to gastric mucosa with floating nature caused by chitosan coating for wide distribution throughout GIT. Developed beads were evaluated for characteristics like beads size-morphology, entrapment efficiency, DSC, XRD, FTIR, swelling ratio, in vitro mucoadhesion, in vitro drug release, in vitro floating and in vitro H. pylori growth inhibition studies. CCA-CPG-A beads were studied in Wistar rats for in vivo gastric mucoadhesion, in vivo H. pylori growth inhibition studies using PCR amplification of isolated DNA, rapid urease test.
Result: Developed beads possess drug release of 79-92%, entrapment efficiency of 65-89%, mucoadhesion of 61-89%. In vivo mucoadhesion study showed more than 85% mucoadhesion of beads even after 7th hour. In vitro-in vivo growth inhibition study showed complete eradication of H. pylori.
Discussion: CPG-alginate and chitosan in beads interacts with gastric mucosubstrate surface for prolonged gastric residence with floating bioadhesion mechanism for H. pylori eradication in rats.
Conclusion: Floating bioadhesive CCA-CPG-A beads offer a promising drug delivery system for H. pylori eradication at lower dose, reduced adverse effect and enhance bioavailability.
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Training healthcare professionals in research methodology is essential to promote research and innovation. This is particularly relevant in India, where there is a wealth of potential drug candidates ...from Indian Traditional Medicine (TM) systems that await exploration and scientific validation using modern medicine principles. Surprisingly, there is a lack of reported activities to train modern medicine practitioners in TM research in the literature. Recognising this need, a structured training program was planned and conducted under the auspices of the Indian Council of Medical Research (ICMR) to train modern medicine practitioners in TM research. A survey was conducted among modern medicine practitioners to assess training gaps and identify key areas to be covered in the workshop modules. The workshop received a positive response, as evidenced by the numerous registration applications and positive feedback from participants. The present article shares the experiences of conducting the pilot workshop, which may serve as a valuable resource for planning similar workshops.
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