Studies of the Dosage Form and Stability of the Drug by Various Techniques

A special issue of Processes (ISSN 2227-9717). This special issue belongs to the section "Pharmaceutical Processes".

Deadline for manuscript submissions: closed (5 November 2023) | Viewed by 41273

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Department of Analytical Chemistry, Faculty of Pharmaceutical Sciences in Sosnowiec, Medical University of Silesia in Katowice, Jagiellońska 4, 41-200 Sosnowiec, Poland
Interests: liquid chromatography; spectrophotometry; densitometry; organic compounds analysis; QSAR; QSRR; QSPR; pharmaceutical analysis; purity of pharmaceutical preparations
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Special Issue Information

Dear Colleagues,

Stability determines the shelf-life of drugs, during which their pharmacological activities do not decline and any degradation products are nontoxic. The medicinal product remains stable if the declared content of the drug substance does not differ by more than 5%, the decomposition products and microbiological contamination are within the acceptable standards, and there are no changes in the appearance and physical properties of the preparation or drug substance release. Ensuring the stability of a medicinal product begins at the stage of drug substance synthesis, then during technological processes (granulation, tableting), packaging (placing in immediate packaging), distribution (wholesalers, pharmacies) and administration to the patient.

This Special Issue, “Studies of the dosage form and stability of the drug by various techniques”, aims to curate novel advances in the development and application of different analytical techniques in drug analyses. Topics include, but are not limited to:

  • the dosage form of the drug and its stability;
  • physical factors influencing the shelf life of medicinal products;
  • chemical factors influencing the shelf life of medicinal products;
  • microbiological factors influencing the shelf life of medicinal products;
  • stabilization treatments during drug preparation;
  • drug stability study;
  • drug purity testing;
  • the use of new media in the formulation of a dosage form with model substances;
  • influence of the composition of the tablet mass on the availability of micro and macro elements;
  • determination of the active substance in medicinal products;
  • drug quality assessment;
  • dosage form technology.

Prof. Dr. Alina Pyka-Pająk
Guest Editor

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Keywords

  • drug analysis
  • drug stability
  • dosage form
  • analytical methods

Published Papers (11 papers)

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Research

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14 pages, 2508 KiB  
Article
Thermal Stability and Kinetics of Degradation of Moxonidine as Pure Ingredient vs. Pharmaceutical Formulation
by Bianca Baul, Adriana Ledeţi, Denisa Cîrcioban, Amalia Ridichie, Titus Vlase, Gabriela Vlase, Francisc Peter and Ionuţ Ledeţi
Processes 2023, 11(6), 1738; https://doi.org/10.3390/pr11061738 - 7 Jun 2023
Cited by 1 | Viewed by 1422
Abstract
The stability of active pharmaceutical ingredients (APIs) and the corresponding pharmaceutical formulations are nowadays of great importance in pharmaceutical research and technology. The quality of an API or of finished pharmaceutical products (FPPs) is time dependent under the influence of several parameters, such [...] Read more.
The stability of active pharmaceutical ingredients (APIs) and the corresponding pharmaceutical formulations are nowadays of great importance in pharmaceutical research and technology. The quality of an API or of finished pharmaceutical products (FPPs) is time dependent under the influence of several parameters, such as light and air exposure, temperature, and humidity. Additionally, the stability profile of an API is influenced by the formulation composition, due to the presence of excipients or by the characteristic of the packaging materials. In this sense, the main objective of this study was to analyze the degradation kinetics of the antihypertensive drug moxonidine as a pure ingredient (MOX) and in two different solid mixtures, one corresponding to a pharmaceutical formulation (MOXTAB) and the other to an enriched pharmaceutical formulation in MOX (MOXMIX). As investigation techniques, FTIR (Fourier transform infrared) spectroscopy and TG/DTG/HF analysis were employed, while the thermoanalytical data were processed according to the ASTM E698 kinetic method and the isoconversional methods of Flynn–Wall–Ozawa (FWO) and Friedman (FR). The kinetic methods revealed that the excipients have a stabilizing effect on MOX (in terms of Ea values), but the decomposition mechanism of the samples is complex, according to the results suggested by the analysis of Ea vs. α values. Full article
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19 pages, 1620 KiB  
Article
The Stability Study of Cefepime Hydrochloride in Various Drug Combinations
by Joanna Żandarek, Żaneta Binert-Kusztal, Małgorzata Starek and Monika Dąbrowska
Processes 2023, 11(2), 602; https://doi.org/10.3390/pr11020602 - 16 Feb 2023
Viewed by 2181
Abstract
Modern antibiotics face many obstacles, starting with the ever-increasing resistance of microorganisms directed against the antibiotic. An important problem is also the existing trend of polypharmacy. The aim of this study was to develop qualitative and quantitative conditions for the determination of cefepime-hydrochloride [...] Read more.
Modern antibiotics face many obstacles, starting with the ever-increasing resistance of microorganisms directed against the antibiotic. An important problem is also the existing trend of polypharmacy. The aim of this study was to develop qualitative and quantitative conditions for the determination of cefepime-hydrochloride solution individually and in mixtures containing other substances with biological activity, such as ketoprofen, gestodene with ethinylestradiol, estradiol, caffeine, calcium ions, paracetamol, bisoprolol, acetylsalicylic acid and ibuprofen, using thin-layer chromatography combined with densitometric analysis. The influence of temperature on the stability of cefepime in these situations was investigated. Furthermore, the effect of UV radiation on the stability of the antibiotic in model drug mixtures was tested. On the basis of the dependence of changes on the concentration of cefepime over time, the order of the reaction was designated, followed by the kinetic parameters of the reactions. Statistical analysis proved that the rate-of-concentration changes in the analyzed conditions corresponded to first-order kinetics. In the course of optimizing the analytical procedure, taking into account the lack of interference of the main peak with the additional peaks and the retardation factor (RF), the mobile phase with the composition of ethanol: 2-propanol: acetone: water (4:4:1:3, v/v/v/v) was selected, while silica gel 60F254 TLC plates were used as the stationary phase. Cefepime-peak areas obtained during the analysis at the analyzed time points allowed us to conclude that the stability of the antibiotic decreased with increasing temperature. The greatest stability was obtained in mixtures with calcium ions (half-life values (t0.5) up to 1320.00 h), while the greatest degradation occurred in combination with hormones (t0.5, 2.00 h at 40 °C). Studies have also demonstrated the destructive UV-radiation impact on the stability of these antibiotic-drug combinations (t0.5, 0.23–0.71 h). Full article
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20 pages, 2962 KiB  
Article
TLC–Densitometric Analysis of Selected 5-Nitroimidazoles
by Alina Pyka-Pająk
Processes 2023, 11(1), 170; https://doi.org/10.3390/pr11010170 - 5 Jan 2023
Cited by 1 | Viewed by 1521
Abstract
Metronidazole, ornidazole, tinidazole, and secnidazole are 5-nitroimidazoles. The purpose of this work was to propose a new economical TLC–densitometric method to evaluate the chemical stability of metronidazole, secnidazole, ornidazole, and tinidazole under stress conditions. A forced degradation study was performed on silica gel [...] Read more.
Metronidazole, ornidazole, tinidazole, and secnidazole are 5-nitroimidazoles. The purpose of this work was to propose a new economical TLC–densitometric method to evaluate the chemical stability of metronidazole, secnidazole, ornidazole, and tinidazole under stress conditions. A forced degradation study was performed on silica gel and aqueous solutions at various pH values; the metronidazole, secnidazole, ornidazole, and tinidazole solutions were prepared in saline and in hydrogen peroxide, respectively. The samples of the 5-nitroimidazoles were heated. TLC analyses were performed on silica gel 60F254 using chloroform–methanol (9:1, v/v) as the mobile phase. As the TLC–densitometric method can effectively separate the metronidazole, secnidazole, ornidazole, and tinidazole from their degradation products which formed as a result of the stress studies, it is considered to can be a good alternative and important tool in the routine quality control and stability testing of metronidazole, secnidazole, ornidazole, and tinidazole in pharmaceutical formulations. The results indicate that the proposed TLC–densitometric method is cost-effective, rapid, specific, accurate, and precise; the TLC–densitometric method also realizes the criterion of the linearity. A major advantage of the proposed method is its low cost and ability to analyze the 5-nitroimidazole which was investigated and all its degradation products simultaneously. Full article
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18 pages, 2014 KiB  
Article
Assessment of a Diverse Array of Nitrite Scavengers in Solution and Solid State: A Study of Inhibitory Effect on the Formation of Alkyl-Aryl and Dialkyl N-Nitrosamine Derivatives
by Miha Homšak, Marko Trampuž, Klemen Naveršnik, Zoran Kitanovski, Mateja Žnidarič, Markus Kiefer and Zdenko Časar
Processes 2022, 10(11), 2428; https://doi.org/10.3390/pr10112428 - 17 Nov 2022
Cited by 12 | Viewed by 13774
Abstract
The ubiquitous presence of mutagenic and potentially carcinogenic N-nitrosamine impurities in medicines has become a major issue in the pharmaceutical industry in recent years. Rigorous mitigation strategies to limit their amount in drug products are, therefore, needed. The removal of nitrite, which [...] Read more.
The ubiquitous presence of mutagenic and potentially carcinogenic N-nitrosamine impurities in medicines has become a major issue in the pharmaceutical industry in recent years. Rigorous mitigation strategies to limit their amount in drug products are, therefore, needed. The removal of nitrite, which is a prerequisite reagent for the N-nitrosation of amines, has been acknowledged as one of the most promising strategies. We have conducted an extensive literature search to identify nineteen structurally diverse nitrite scavengers and screened their activity experimentally under pharmaceutically relevant conditions. In the screening phase, we have identified six compounds that proved to have the best nitrite scavenging properties: ascorbic acid (vitamin C), sodium ascorbate, maltol, propyl gallate, para-aminobenzoic acid (PABA), and l-cysteine. These were selected for investigation as inhibitors of the formation of N-methyl-N-nitrosoaniline (NMA) from N-methylaniline and N-nitroso-N’-phenylpiperazine (NPP) from N-phenylpiperazine in both solution and model tablets. Much faster kinetics of NMA formation compared to NPP was observed, but the former was less stable at high temperatures. Vitamin C, PABA, and l-cysteine were recognized as the most effective inhibitors under most studied conditions. The nitrite scavenging activity does not directly translate into N-nitrosation inhibitory effectiveness, indicating other reaction pathways may take place. The study presents an important contribution to identifying physiologically acceptable chemicals that could be added to drugs to prevent N-nitrosation during manufacture and storage. Full article
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16 pages, 3197 KiB  
Article
How Does Long-Term Storage Influence the Physical Stability and Dissolution of Bicalutamide from Solid Dispersions and Minitablets?
by Agata Antosik-Rogóż, Joanna Szafraniec-Szczęsny, Justyna Knapik-Kowalczuk, Mateusz Kurek, Karolina Gawlak, Marian Paluch and Renata Jachowicz
Processes 2022, 10(5), 1002; https://doi.org/10.3390/pr10051002 - 18 May 2022
Viewed by 2105
Abstract
The stability of amorphous drugs is among the main challenges in the development of solid dosage forms. This paper examines the effect of storage conditions (25 °C/60% RH and 40 °C/75% RH) and different packaging materials, i.e., polystyrene containers and PVC/Al blisters, on [...] Read more.
The stability of amorphous drugs is among the main challenges in the development of solid dosage forms. This paper examines the effect of storage conditions (25 °C/60% RH and 40 °C/75% RH) and different packaging materials, i.e., polystyrene containers and PVC/Al blisters, on the crystallinity and dissolution characteristics of solid dispersions containing bicalutamide and polyvinylpyrrolidone. The results confirmed drug amorphization upon milling and improved dissolution resulting from the lack of a crystal lattice. These properties varied with time regarding sample composition, storage conditions, and packaging material. The most resistant to storage conditions was the 1:1 solid dispersion packed into blisters. Based on the obtained results, the 1:1 solid dispersion was formulated into minitablets, which were then tested after tableting and then packed into PVC/Al blisters and stored for six months in the same conditions as solid dispersions. We proved that efficient stabilization of amorphous bicalutamide depends on the barrier properties of packaging materials and that a properly chosen material protected the drug substance from the influence of unfavorable storage conditions such as elevated temperature and humidity. Full article
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16 pages, 3080 KiB  
Article
Network-Based Approach to Repurpose Approved Drugs for COVID-19 by Integrating GWAS and Text Mining Data
by Shuang Liang, Hui-Min Liu, Dan-Yang Liu, Wan-Qiang Lv, Sheng-Ran Wang, Jia-Chen Liu, Jonathan Greenbaum, Hui Shen, Hong-Mei Xiao and Hong-Wen Deng
Processes 2022, 10(2), 326; https://doi.org/10.3390/pr10020326 - 8 Feb 2022
Cited by 1 | Viewed by 2161
Abstract
The coronavirus disease 19 (COVID-19) is a global pandemic caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), which has a rapidly increasing prevalence and has caused significant morbidity/mortality. Despite the availability of many vaccines that can offer widespread immunization, it is also [...] Read more.
The coronavirus disease 19 (COVID-19) is a global pandemic caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), which has a rapidly increasing prevalence and has caused significant morbidity/mortality. Despite the availability of many vaccines that can offer widespread immunization, it is also important to reach effective treatment for COVID-19 patients. However, the development of novel drug therapeutics is usually a time-consuming and costly process, and therefore, repositioning drugs that were previously approved for other purposes could have a major impact on the fight against COVID-19. Here, we first identified lung-specific gene regulatory/interaction subnetworks (COVID-19-related genes modules) enriched for COVID-19-associated genes obtained from GWAS and text mining. We then screened the targets of 220 approved drugs from DrugBank, obtained their drug-induced gene expression profiles in the LINCS database, and constructed lung-specific drug-related gene modules. By applying an integrated network-based approach to quantify the interactions of the COVID-19-related gene modules and drug-related gene modules, we prioritized 13 approved drugs (e.g., alitretinoin, clocortolone, terazosin, doconexent, and pergolide) that could potentially be repurposed for the treatment of COVID-19. These findings provide important and timely insights into alternative therapeutic options that should be further explored as COVID-19 continues to spread. Full article
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17 pages, 5369 KiB  
Article
Modelling and Control of Corticotropin Permeation from Hydrogels across a Natural Membrane in the Presence of Albumin
by Wioletta Siemiradzka, Barbara Dolińska and Florian Ryszka
Processes 2021, 9(9), 1674; https://doi.org/10.3390/pr9091674 - 18 Sep 2021
Cited by 4 | Viewed by 1639
Abstract
(1) Background: Skin is a difficult barrier to overcome, especially for molecules with masses greater than 500 Da. It has been suggested that albumin may contribute to more effective penetration of many therapeutic substances. In this study, an attempt was made to use [...] Read more.
(1) Background: Skin is a difficult barrier to overcome, especially for molecules with masses greater than 500 Da. It has been suggested that albumin may contribute to more effective penetration of many therapeutic substances. In this study, an attempt was made to use albumin in semi-solid formulations to increase the skin penetration of another peptide—corticotropin (ACTH). (2) Methods: Hydrogels were prepared at two concentrations: 15 mg/g and 20 mg/g corticotropin, then albumin was added to them in different stoichiometric ratios. The degree of ACTH release from hydrogels, both with and without albumin addition, was investigated. For selected hydrogels the process of corticotropin permeation through a model membrane, i.e., pig skin, was examined. (3) Results: The study of corticotropin release showed that the addition of albumin, depending on its amount, may delay or increase the release process. Similarly, a study of ACTH permeation through porcine skin showed that albumin can delay or increase and accelerate ACTH permeation. (4) Conclusions: Hydrogel, applicated on the skin surface, may prove to be a beneficial and convenient solution for patients. It is an innovative way of application ACTH that bypasses the gastrointestinal tract and may result in increased availability of the peptide and its efficacy. Full article
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15 pages, 2222 KiB  
Article
Ecofriendly Simple UV Spectrophotometric and Chemometric Methods for Simultaneous Estimation of Paracetamol Aceclofenac and Eperisone Hydrochloride in Pharmaceutical Formulation: Assessment of Greenness Profile
by Seetharaman Rathinam and Lakshmi Karunanidhi Santhana
Processes 2021, 9(8), 1272; https://doi.org/10.3390/pr9081272 - 23 Jul 2021
Cited by 4 | Viewed by 2930
Abstract
This work introduces three eco-friendly UV spectrophotometric methods for the simultaneous estimation of Paracetamol, Aceclofenac and Eperisone Hydrochloride in pharmaceutical tablet formulation. The procedures employed were simultaneous equation method and multivariate chemometric methods with phosphate buffer pH 7.80 as diluent. The simultaneous equation [...] Read more.
This work introduces three eco-friendly UV spectrophotometric methods for the simultaneous estimation of Paracetamol, Aceclofenac and Eperisone Hydrochloride in pharmaceutical tablet formulation. The procedures employed were simultaneous equation method and multivariate chemometric methods with phosphate buffer pH 7.80 as diluent. The simultaneous equation method encompasses absorbance measurement at three different wavelengths (λmax of the drugs). It exhibits linearity between 12–18 µg mL−1 for paracetamol, 3.69–5.53 µg mL−1 for Aceclofenac, and 2.76–4.15 µg mL−1 Eperisone hydrochloride. The results obtained for accuracy and precision by the simultaneous equation method were within the permissible limits. Principal component regression and partial least squares were the tools used for chemometric methods. The calibration set and prediction set were constructed, and the UV spectra were recorded in zero order mode, further subjected to chemometric analysis. The % recoveries obtained for Paracetamol, Aceclofenac, and Eperisone Hydrochloride by chemometric techniques showed good accuracy, and the results obtained for analytical figures of merit were acceptable. Statistical comparison of the assay results obtained for the proposed methods showed no significant difference found among the methods using one way analysis of variance. Greenness evaluation tools revealed the greenness profile of the proposed methods and found them to be ecofriendly. The described methods were appropriate for routine quality control laboratories, facilitating eco-friendly, fast, and cost effective determination of Paracetamol, Aceclofenac, and Eperisone Hydrochloride in Acemyoset P tablets. Full article
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Review

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26 pages, 410 KiB  
Review
UPLC Technique in Pharmacy—An Important Tool of the Modern Analyst
by Paweł Gumułka, Joanna Żandarek, Monika Dąbrowska and Małgorzata Starek
Processes 2022, 10(12), 2498; https://doi.org/10.3390/pr10122498 - 24 Nov 2022
Cited by 7 | Viewed by 3449
Abstract
In recent years, ultra-efficient liquid chromatography (UPLC) has gained particular popularity due to the possibility of faster separation of small molecules. This technique, used to separate the ingredients present in multi-component mixtures, has found application in many fields, such as chemistry, pharmacy, food, [...] Read more.
In recent years, ultra-efficient liquid chromatography (UPLC) has gained particular popularity due to the possibility of faster separation of small molecules. This technique, used to separate the ingredients present in multi-component mixtures, has found application in many fields, such as chemistry, pharmacy, food, and biochemistry. It is an important tool in both research and production. UPLC created new possibilities for analytical separation without reducing the quality of the obtained results. This technique is therefore a milestone in liquid chromatography. Thanks to the increased resolution, new analytical procedures, in many cases, based on existing methods, are being developed, eliminating the need for re-analysis. Researchers are trying to modify and transfer the analytical conditions from the commonly used HPLC method to UPLC. This topic may be of strategic importance in the analysis of medicinal substances. The information contained in this manuscript indicates the importance of the UPLC technique in drug analysis. The information gathered highlights the importance of selecting the appropriate drug control tools. We focused on drugs commonly used in medicine that belong to various pharmacological groups. Rational prescribing based on clinical pharmacology is essential if the right drug is to be administered to the right patient at the right time. The presented data is to assist the analyst in the field of broadly understood quality control, which is very important, especially for human health and treatment. This manuscript shows that the UPLC technique is now an increasingly used tool for assessing the quality of drugs and determining the identity and content of active substances. It also allows the monitoring of active substances and finished products during their processing and storage. Full article
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Other

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9 pages, 873 KiB  
Case Report
Individualized Dosage Optimization for Myeloablative Conditioning before Unrelated Cord Blood Transplantation in a Diamond–Blackfan Anemia Patient with Germline RPL11 Mutation: A Case Study
by Rong-Long Chen, Li-Hua Fang and Liuh-Yow Chen
Processes 2022, 10(2), 201; https://doi.org/10.3390/pr10020201 - 21 Jan 2022
Viewed by 1871
Abstract
Unrelated cord blood transplantation (CBT) for Diamond–Blackfan anemia (DBA), a systemic ribosomopathy affecting the disposition of conditioning agents, has resulted in outcomes inferior to those by transplantations from matched donors. We report the experience of the pharmacokinetics-guided myeloablative unrelated CBT in a DBA [...] Read more.
Unrelated cord blood transplantation (CBT) for Diamond–Blackfan anemia (DBA), a systemic ribosomopathy affecting the disposition of conditioning agents, has resulted in outcomes inferior to those by transplantations from matched donors. We report the experience of the pharmacokinetics-guided myeloablative unrelated CBT in a DBA patient with a germline RPL11 mutation. The conditioning consisted of individualized dosing of fludarabine (based on weight and renal function with a target area under the curve (AUC) of 17.5 mg·h/L) and busulfan (based on therapeutic drug monitoring with a target AUC of 90 mg·h/L), as well as dosing and timing of thymoglobulin (based on body weight and pre-dose lymphocyte count to target pre-CBT AUC of 30.7 AU·day/mL and post-CBT AUC of 4.3 AU·day/mL, respectively). The pharmacokinetic measures resulted in a 27.5% reduction in busulfan and a 35% increase in fludarabine, as well as an over three-fold increase in thymoglobulin dosage with the start time changed to day-9 instead of day-2 compared to regular regimens. The transplantation resulted in rapid, complete, and sustained hematopoietic engraftment. The patient is now healthy over 3 years after CBT. A pharmacokinetics-guided individualized dosing strategy for conditioning might be a feasible option to improve the outcomes of DBA patients receiving unrelated myeloablative CBT. Full article
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14 pages, 1605 KiB  
Perspective
PBPK Modeling and Simulation and Therapeutic Drug Monitoring: Possible Ways for Antibiotic Dose Adjustment
by Abigail Ferreira, Rui Lapa and Nuno Vale
Processes 2021, 9(11), 2087; https://doi.org/10.3390/pr9112087 - 22 Nov 2021
Cited by 6 | Viewed by 5989
Abstract
Pharmacokinetics (PK) is a branch of pharmacology present and of vital importance for the research and development (R&D) of new drugs, post-market monitoring, and continued optimizations in clinical contexts. Ultimately, pharmacokinetics can contribute to improving patients’ clinical outcomes, helping enhance the efficacy of [...] Read more.
Pharmacokinetics (PK) is a branch of pharmacology present and of vital importance for the research and development (R&D) of new drugs, post-market monitoring, and continued optimizations in clinical contexts. Ultimately, pharmacokinetics can contribute to improving patients’ clinical outcomes, helping enhance the efficacy of treatments, and reducing possible adverse side effects while also contributing to precision medicine. This article discusses the methods used to predict and study human pharmacokinetics and their evolution to the current physiologically based pharmacokinetic (PBPK) modeling and simulation methods. The importance of therapeutic drug monitoring (TDM) and PBPK as valuable tools for Model-Informed Precision Dosing (MIPD) are highlighted, with particular emphasis on antibiotic therapy since dosage adjustment of antibiotics can be vital to ensure successful clinical outcomes and to prevent the spread of resistant bacterial strains. Full article
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