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- Simplifying Pharmacokinetics, Applying it to Drug and Dosage Form
Development, and Making Drug Dosage Decisions in Clinical Medicine: The
Adaptation of Kirchhoff’s Laws from Physics-
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Abstract: Over the past three years, we have published a series of nine manuscripts demonstrating that all relevant pharmacokinetic relationships may be simply derived independent of differential equations, offering an alternative to traditional pharmacokinetic analyses. These derivations are based on an understanding of parallel and in series rate-defining processes, and account for all relevant drivers, including organ blood flow and drug delivery clearance kinetics, across both linear and nonlinear scenarios. In this tutorial, we present the simple derivation of renal clearance and hepatic clearance directly relevant to clinical pharmacokinetics, as applied to making drug dosing decisions based on measures of systemic exposure. We further advocate for a more streamlined and practical approach to teaching and applying clinical pharmacokinetics, noting that compartmental modeling, protein binding in hypothetical compartments, trapezoidal AUC calculations, and alternative volume of distribution parameters, aside from (the unfortunately misnamed) volume of distribution steady-state, often overcomplicate pharmacokinetics in practice. The key advantage of this simplified methodology is the ability to directly incorporate clearance from the drug delivery site into systemic pharmacokinetic relationships. This enables a clear understanding of how entering clearance can influence systemic AUC, helping explain: enhanced pharmacodynamic outcomes of slow drug delivery versus immediate-release formulations; systemic bioavailability measures exceeding unity, statistically significant discrepancies between urinary and systemic bioavailability measures; and changes in renal clearance as a function of drug clearance from the delivery site. These key concepts are illustrated by applying the proposed methodology to an example drug, analyzing all relevant clinical pharmacokinetic relationships required for dosing decisions. Graphical Abstract
PubDate: 2025-07-03
- Enhanced Nanoprecipitation Method for the Production of PLGA Nanoparticles
for Oncology Applications-
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Abstract: Herein, we report a new modified nanoprecipitation method for the fabrication of water-dispersible Poly(lactic-co-glycolic acid) (PLGA) nanoparticles encapsulating three poorly water-soluble anticancer agents as model drugs: paclitaxel (PTX), docetaxel (DTX) or curcumin (Cur). These nanoparticles were water dispersible with favourable size for anticancer applications (below 200 nm) and relatively high drug loading (6.3–8.9%). These nanoparticles were stable for four weeks in solid state and up to 48 h when dispersed in water. PTX and Cur nanoparticles showed a very minimal release of the payload during a 72-h in vitro release study. The new method also yielded reproducible results across three different batches of each type of nanoparticles and following three times upscaling of PTX nanoparticles. PTX and Cur nanoparticles were more effective than the free drugs against MDA-MB-231 cells (p
PubDate: 2025-06-27
- Dissolution of Oral Solid Dosage Formulations: Surrogate Models and
Real-time Release-
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Abstract: In vitro dissolution testing is commonly performed to ensure that oral solid dosage medicines are of high quality and will achieve their targeted in vivo performance. However, this testing is time and material consuming. Therefore, pharmaceutical companies have been developing predictive dissolution models (PDMs) for drug product release based on fast at- and/or on-line measurements, including real-time release testing of dissolution (RTRT-D). Recently, PDMs have seen acceptance by major regulatory bodies as release tests for the dissolution critical quality attribute. In this paper, several methodologies are described to develop and validate a fit-for-purpose model, then to implement it as a surrogate release test for dissolution. These approaches are further exemplified by real-life case studies, which demonstrate that PDMs for release are not only viable but more sustainable than in vitro dissolution testing and can significantly accelerate drug product release. The rise of continuous manufacturing within the pharmaceutical industry further favors the implementation of real-time release testing. Therefore, a steep uptake of PDMs for release is expected once this methodology is globally accepted. To that end, it is advantageous for global regulators and pharmaceutical innovators to coalesce around a harmonized set of expectations for development, validation, implementation, and lifecycle of PDMs as part of drug product release testing. Graphical Abstract
PubDate: 2025-06-27
- Procedural Variation May Contribute to 6-Minute Walk Distance Variability
in Real-World Pediatric Pulmonary Arterial Hypertension Study-
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Abstract: The six-minute walk test (6MWT) is a common method to assess submaximal exercise capacity in children and adults with pulmonary arterial hypertension (PAH) and other chronic diseases. There is no guideline specifically for 6MWT in children. In this observational pilot study, we evaluated the impact of procedural variations on the outcome of the 6MWT in the real-world clinical setting at pediatric PAH programs. We collected 6MWT data from 33 children with PAH participating in a multicenter, prospective, non-interventional study. Data range/quantiles and standard deviation (SD) were used to describe distribution of the six-minute walk distance (6MWD) and data variability. Levene’s test was used to test for heterogeneity of variance with the two sites of similar altitude and their age/height/weight-matched Panama Function Class II participants. We analyzed all 33 eligible participants and their qualified first walks at five centers (A-E) with 6MWD ranges of 420–570, 357–683, 418–481, 400–700, 377–549 m, respectively. Site D performed the 6MWT in a busy hallway and allowed parental/caregiver’s cheering, while Site E performed the 6MWT in a secluded area with no parental/caregiver involvement. Mean 6MWD and SD for Sites D and E were 547 (125) and 432 (67.5) meters, respectively (p = 0.03). In conclusion, procedural variations seem to associate with 6MWD data variability. Although interpretation of our results is limited by the small sample size, our findings suggest that standardizing pediatric 6MWT procedures are needed. Graphical Abstract
PubDate: 2025-06-27
- Pharmacokinetics and Pharmacodynamics of Nomlabofusp in Non-clinical
Studies of Friedreich’s Ataxia-
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Abstract: Nomlabofusp is a cell penetrant peptide-based recombinant fusion protein designed to enter cells and deliver human frataxin into the mitochondria of adults and children with Friedreich’s ataxia. In this article we present non-clinical studies evaluating the pharmacology of nomlabofusp, including in a murine striated muscle tissue frataxin knockout model of Friedreich’s ataxia. We demonstrate that subcutaneous administration of nomlabofusp distributes in a dose-dependent manner to several organs including the dorsal root ganglion, heart, and skeletal muscle, which are known to be predominantly affected in Friedreich’s ataxia, as well as to other tissues, including skin. Plasma nomlabofusp concentrations correlated with levels of human frataxin delivered by nomlabofusp into tissues, and the increases in frataxin were correlated amongst tissues, especially with skin. In the knockout mice, we show that the pharmacokinetics and processing of nomlabofusp were comparable with wild type animals and that treatment with nomlabofusp halts the progression of cardiac dysfunction and significantly increased survival. Together, the findings from these non-clinical studies demonstrate that nomlabofusp exposure increases human frataxin in Friedreich’s ataxia-relevant tissues and provide evidence of pharmacologic effects. Graphical Abstract
PubDate: 2025-06-25
- Correction: Immunogenicity of Atezolizumab: Influence of Testing Method
and Sampling Frequency on Reported Anti-drug Antibody Incidence Rates-
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PubDate: 2025-06-20
- Effect of Alternative Administrations on P2Y12 Receptor Inhibitors’
Pharmacokinetics and Pharmacodynamics: Systematic Review and Meta-Analysis
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Abstract: Alternative administrations methods, such as chewing or crushing tablets, have been proposed to improve P2Y12 receptor inhibitors’ absorption in acute and chronic coronary syndromes. This study aimed to evaluate the impact of these alternative strategies on the pharmacokinetics and pharmacodynamics of clopidogrel, ticagrelor, and prasugrel. PubMed, the Cochrane Library, and Web of Science were searched until March 07, 2025 for trials comparing at least one P2Y12 receptor inhibitor alternative administration method to the standard administration (swallowed integral tablets). Drug concentrations, platelet reactivity, and rates of high on-treatment platelet reactivity (HPR) were evaluated by standardized mean differences (SMD) or odds ratios (OR) with 95% confidence interval (CI) using random-effects models. The effects of specific P2Y12 inhibitors and administration methods were assessed using meta-regression. Eleven studies (1,735 patients) were included. Administration of crushed or chewed tablets led to an increase in drug concentrations (SMD at 1 h 0.48, 95% CI 0.001 to 0.95, p
PubDate: 2025-06-18
- Dose Optimization of ClpP Agonists Using an In Vitro Microfluidic
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Abstract: Small molecule activators of the mitochondrial caseinolytic protease P (ClpP agonists) can disrupt tumor metabolism and deprive tumors of their energy needs. The imipridone, ONC201, is a ClpP agonist currently undergoing clinical evaluation across multiple cancer types, while additional analogs with improved potency and selectivity are in preclinical development. Preclinical studies in mice have demonstrated a unique pharmacokinetic-pharmacodynamic (PK-PD) relationship for ONC201 characterized by prolonged pharmacology following a single dose. This motivated the selection of an initial human dosing regimen of every three weeks, and subsequent dose exploration studies in mice led to dose intensification in human patients. However, a systematic analysis of ClpP agonist PK-PD relationships has not been performed, and the optimal exposure profile for ClpP agonists remains undefined. To address this gap, we combined PK-PD modeling with a microfluidic perfusion platform as an animal-alternative approach for translational PK-PD of ClpP agonists. We demonstrate that the anti-proliferative effect on triple negative breast cancer cells correlates with the magnitude and duration of ClpP agonist exposure above a threshold concentration required for ClpP activation. Moreover, we demonstrate that PK-PD model simulations using parameters derived from microfluidic perfusion datasets can successfully predict the anti-tumor efficacy of a ClpP agonist in a mouse tumor xenograft study. These studies support the translational relevance of the animal-alternative in vitro PK-PD platform and its utility to help guide dose optimization of ClpP agonists as cancer therapeutics. Graphical Abstract
PubDate: 2025-06-13
- Factors Impacting the Immunogenicity of Etrolizumab & Clinical
Consequences-
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Abstract: Ulcerative colitis (UC) and Crohn's disease (CD), pose a substantial burden, necessitating effective therapies. Etrolizumab, a unique monoclonal antibody targeting integrins, initially showed promise but was t...
PubDate: 2025-06-06
- Automation of Anti-Drug Antibody Enrichment Using Streptavidin PhyTip®
Columns for Sample Pretreatment in an Immunogenicity Assay-
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Abstract: The administration of biotherapeutics has the potential to induce potent immune responses, including the induction of anti-drug antibodies (ADA) (1). Detection and characterization of ADA in clinical trials is...
PubDate: 2025-06-06
- Correction: Nitrosamines Risk Assessment for Biopharmaceutics
Classifcation System Class IV Molecule Containing Immediate Release
Products: Use of In-Silico Prediction Tools and Physiologically Based
Pharmacokinetic Modeling-
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PubDate: 2025-06-04
- The 100th Monoclonal Antibody Product is Approved in Japan
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Abstract: The Pharmaceuticals and Medical Devices Agency (PMDA) is a Japanese authority responsible for reviewing the quality, efficacy, and safety of drugs and medical devices to be marketed for public health protection. This study investigated the approval numbers of monoclonal antibodies (mAbs). In addition, it classified canonical and modified antibodies, such as antibody–drug conjugates (ADCs), antibody fragments, and bispecific antibodies (bsAb), excluding the biosimilar versions of mAbs in each fiscal year (FY) based on the PMDA website (1). Moreover, the approval FY data, brand names, international nonproprietary names, cell substrates, targets, disease areas at initial approval, and regulatory pathways were compiled (Supplement Document 1).
PubDate: 2025-06-04
- Correction: Establishing Clinically Relevant Specifications for
Carbamazepine Tablets Using Physiologically Based Pharmacokinetic Modeling
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PubDate: 2025-06-04
- Improving the Therapeutic Selectivity of Trastuzumab Deruxtecan Using 8C2
Fab Fragments-
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Abstract: DXd, a camptothecin derivative, is employed as the payload molecule for the antibody–drug conjugate (ADC) trastuzumab deruxtecan (T-DXd), which is in current clinical use for the treatment of breast and gastric cancer. Despite the clinical success of ADCs for treatment of cancer, exposure to released payload in plasma and extracellular fluids contributes to off-target toxicities, which limit ADC dosage and efficacy. In this study, we evaluated an anti-DXd antibody fragment, 8C2 Fab, for utility in mitigating DXd toxicity in cell culture and for improving the therapeutic index of T-DXd in vivo in mice. 8C2 Fab was produced, purified, and characterized for binding to DXd and T-DXd. In vitro competitive cytotoxicity assays showed that 8C2 Fab blocked the cell-killing effect of DXd, increasing the DXd concentration associated with 50% growth inhibition (IC50) by 50-fold; however, 8C2 did not decrease the cytotoxicity of T-DXd. Co-administration of 8C2 Fab to mice with 600 mg/kg T-DXd significantly decreased the percentage body weight loss at nadir in mice compared to results found with T-DXd alone (12.8 ± 3.66% vs 7.08 ± 4.24%, p = 0.0331). In contrast, co-administration of 8C2 Fab with T-DXd (1 or 10 mg/kg) did not negatively impact the anti-tumor efficacy in mice bearing NCI-N87 xenograft tumors. Our results demonstrate that 8C2 Fab decreases DXd cytotoxicity in vitro, and decreases T-DXd-induced toxicity in vivo, while not inhibiting T-DXd anti-tumor efficacy in vitro or in vivo, supporting utility for improving the therapeutic index of T-DXd. Graphical Abstract
PubDate: 2025-06-04
- A Bottom-up Approach for Mutant and Wild Type Collies Using
Physiologically Based Pharmacokinetic (PBPK) Modeling: A Case Study Using
Loperamide-
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Abstract: A bottom-up physiologically based pharmacokinetic (PBPK) model was developed to predict the pharmacokinetics of loperamide, a substrate for multidrug resistance 1 (Mdr1) encoded P-glycoprotein (P-gp), in wild-type dogs (WT) and dogs that are homozygous for a base-pair deletion in the Mdr1 gene encoding for P-gp (Mu, Δ-Mdr1). In vitro-to-in vivo extrapolation (IVIVE) techniques were employed where in vitro data describing loperamide absorption, distribution, metabolism, and elimination (ADME) were extrapolated to in vivo dose exposure predictions. Importantly, by applying system parameters extrapolated from other breeds and published information on Collie-specific physiology, for the first time, a breed-specific whole-body PBPK model for the Collie was developed. Using our loperamide IVIVE-PBPK model (Simcyp Animal Simulator), the observed plasma concentration-versus-time profiles after intravenous and oral loperamide administration were successfully captured. The overall model performance for the WT (n = 7) and Mu (n = 10) Collies was within 1.40 and 1.24, and 1.18 and 1.51 AAFE for the Area under the plasma concentration–time-profile curve (AUC)0-24 h and maximal plasma concentration (Cmax) predictions, respectively. Predicted Cmax values were within ± 25% of observed values for 67% of all doses for the WT dogs. For the Mu dogs, the predicted AUC0-24 h was within 50% for all doses. Our work provides the first example of a systematic approach for Collies and illustrates its use to describe the impact of a known genetic variation in the canine Mdr1 gene. Furthermore, we describe the general workflow for establishing, verifying, and applying an IVIVE-PBPK framework for predicting in vivo drug behavior within a specific canine breed. Graphical Abstract
PubDate: 2025-06-02
- A Comparative Study on Physicochemical and Analytical Characterizations of
Doxil® and its Generic Drug Products-
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Abstract: Doxil®, a PEGylated liposomal doxorubicin (DOX) hydrochloride suspension, was the first liposome drug product approved by the U.S. Food and Drug Administration (FDA). Although off-patent, limited generic products have been approved due to challenges in achieving bioequivalence compounded by manufacturing complexity. Regulatory agencies require generic drug products to be bioequivalent to the reference listed drug. In this regard, we developed various analytical methods to analyze Doxil® and its generic drug products for multiple attributes, including liposome size distribution, zeta potential, DOX content, lipid content, purity, non-encapsulated doxorubicin, morphology, nanostructure similarity, and quantified in vitro release. Batch-to-batch variation exists across attributes for different formulations. Minor differences in particle size and zeta potential were observed. Cryo-TEM imaging reveals the distinct coffee bean shape and morphology of the Doxil® liposome. SAXS similarity analysis shows a distinct difference in nanostructure for Dr. Reddy’s formulation compared to the innovator formulation. Still, it is revealed to be a consequence of liposome uniformity and homogeneity as depicted in cryo-TEM images. Several methods developed in this work can be complementary to provide a more thorough physicochemical analysis for generic evaluation. Size, morphology, and nanostructure evaluated by DLS, cryo-TEM, and SAXS should be readily employed to assess physicochemical similarity. Content, impurity identification, and amount of free non-encapsulated DOX are used to evaluate formulation sameness. The methods developed in this work provide a physicochemical framework for analytical comparison of complex liposomal generics and may support subsequent development efforts to improve generic drug availability for patient populations in need. Graphical Abstract
PubDate: 2025-06-02
- Evaluating the Impact of AI-Based Model-Informed Drug Development (MIDD):
A Comparative Review-
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Abstract: Model-informed drug development (MIDD) methods play critical role to ensure development of efficacious, and safe individualized therapies. The application of artificial intelligence/machine learning (AI/ML) within the field of drug development has exponentially expanded. Integrating AI/ML into traditional pharmacometrics approaches or using AI/ML as a stand-alone tool has the potential to optimize dosing strategies, inform clinical trial designs, and enhance robustness of quantitative assessments of drug efficacy and safety. This review systematically evaluates the impact of AI-based model-informed drug development (MIDD) methods compared to traditional approaches by blending regulatory perspectives. We conducted a systematic search on PubMed using five Medical Subject Headings (MeSH) terms and included 67 relevant studies in the analysis. The results indicate that AI models have the potential of improving MIDD approaches through different stages of drug development to inform decision-making in clinical trials. However, limitations such as the lack of standardized evaluation metrics and standardized regulatory guidelines on the use of AI-based MIDD methods were noted. Overall, this review highlights the potential applications of AI in drug development and provides a foundation for future research to optimize and integrate AI-based approaches in this field.
PubDate: 2025-06-02
- Application of Real-World Evidence to Support FDA Regulatory Decision
Making-
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Abstract: Real-world data (RWD) and real-world evidence (RWE) are valuable resources for drug development strategies. Historically, it has been used for safety evaluation during post-marketing surveillance. RWD and RWE have been utilized in the regulatory decision-making process for drug effectiveness, especially for rare diseases and cancers, where conducting randomized controlled trials is challenging. The Food and Drug Administration (FDA) is actively working on providing trustworthy information derived from RWD and RWE to supplement the data from clinical trials. This review discusses the potential use of RWE to make regulatory decisions on drug effectiveness for certain therapeutic areas as well as the challenges in drawing inferences on drug effectiveness from RWE. A review of FDA-approved new drug applications and biologics license applications suggests that several methodological considerations should be deliberated when designing a study using RWE to demonstrate product effectiveness. The acceptance of RWE, while promising, is dependent on the relevance and reliability of the data. The insight and engagement of all stakeholders contribute to the successful use of RWE for clinical evaluations. Graphical Abstract
PubDate: 2025-05-28
- Publisher Correction: Generating Realistic Albumin Concentrations in
Virtual Subjects Across A Spectrum of Renal Function to Account for
Variability in Protein Binding Within PBPK Models-
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PubDate: 2025-05-28
- Risk Assessment for Biopharmaceutics Classification System Class IV
Molecule Containing Immediate Release Products: Use of In-Silico
Prediction Tools and Physiologically Based Pharmacokinetic Modeling-
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Abstract: Nitrosamines drug substance related impurities (NDSRI) are organic impurities, highly potent mutagenic substances that are classified as human carcinogens. Regulatory guidance’s in this area provide procedures for control and risk mitigation of NDSRI’s in drug products. While efforts are made to control the NDSRI’s, cases where NDSRI’s are observed post- pivotal bioequivalence studies may require additional bioequivalence studies, between pre- and post- change formulations. The recent USFDA (United State Food and Drug Administration) guidance on “Control of Nitrosamine Impurities in Human Drugs” provides alternative BE methodologies for biopharmaceutics classification system (BCS) I, II and III drugs based on in vitro testing. For BCS IV molecule containing immediate release (IR) formulations, physiologically based pharmacokinetic (PBPK) modeling approach is recommended. In this context, this present article discusses use of PBPK modeling approaches as alternative BE methodologies for BCS IV molecule containing IR products. We have summarized use of in-house in silico tool for early risk prediction of NDSRI’s solely based on molecule structure. This tool was used to predict the carcinogenic potential of 37 BCS IV molecules and further clinical exposure risk assessment was conducted on identified 5 high risk category molecules namely edoxaban, selumetinib, bosutinib, furosemide, hydrochlorothiazide where transporters are involved in absorption. The PBPK models were used to evaluate the impact of altered permeability and transporter kinetics on exposures, that may happen in presence of antioxidants. Further, the impact of permeability within ± 10–20% was evaluated on clinical exposures to determine permeability safe space (region within which bioequivalence is guaranteed as compared to the target formulation). Graphical Abstract
PubDate: 2025-05-28
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