Dose Justification for Nanoparticle Formulation | Chapter 2 | Pharmaceutical Science: New Insights and Developments Vol. 8

 

Dose justification refers to the scientific rationale behind selecting a specific dose of a drug for human use. With the emergence of nanotechnology in pharmaceuticals, particularly nanoparticle formulations, this concept has evolved significantly. This study aims to shed light on the different approaches to justifying the dose of nanoparticles, using ibrutinib nanoparticles as an example. It also examines the relation between the dose and bioavailability, alongside considering relevant pharmacokinetic (PK) and pharmacodynamic (PD) parameters. The biopharmaceutical factors like Cmax, Tmax, and AUC are also considered for dose justification. The comparison of the radiation dose and nanoparticle dose taken internally or externally, and their relation, is highlighted. The NOAEL (No Observed Adverse Effect Level) and its limitations are discussed. The human equivalent dose and inhumane studies were listed along with the equivalent dose of nanoparticles. The Equivalent Dose Model, used in nanotoxicology, is presented as it calculates dose based on nanoparticle surface area rather than mass alone. Comprehensive data support the approval of the 50 mg nanoparticle dose, providing patients with a more effective and safer treatment option. Project Optimus by the FDA, which aims to refine and simplify oncology dose selection, is also considered. Key nanoparticle-specific factors like surface area and zeta potential are explained with the regulatory approvals. Nano drug formulations offer significant improvements in solubility and bioavailability. Incorporating PK/PD data, toxicity thresholds, nanoparticle-specific models, and regulatory guidelines ensures that the new dose maintains safety and efficacy. Finally, the integration of in silico modelling, Quantitative Structure-Activity Relationship model, and machine learning is proposed to enhance dose predictions, with standardised weighting factors suggested to improve risk assessment.

 

Author(s) Details

AVS Rajeswari
Department of Pharmaceutics, Arya College of Pharmacy, Kandi, Hyderabad, India.

 

B. Navya
Arya College of Pharmacy, Kandi, Hyderabad, India.

 

N. Sowmya
Arya College of Pharmacy, Kandi, Hyderabad, India.

 

P. Sailaja
Andhra University College of Pharmaceutical Sciences, Visakhapatnam, AP, India.

 

Please see the book here:- https://doi.org/10.9734/bpi/psnid/v8/6145

Advancements in Therapeutic Drug Monitoring: Integrating Pharmacokinetics, Pharmacodynamics, and Bayesian Approaches for Personalised Medicine | Chapter 6 | Pharmaceutical Research: Recent Advances and Trends Vol. 9

 Therapeutic drug monitoring (TDM) is a critical process in clinical pharmacology that involves measuring drug concentrations in biological fluids to optimize drug dosage and ensure efficacy while avoiding toxicity. By incorporating pharmacokinetics (PK) and pharmacodynamics (PD) principles, TDM allows for individualized therapy, particularly for drugs with narrow therapeutic indices. Recent advancements, including population pharmacokinetic approaches and Bayesian estimation, have enhanced the precision of TDM. This review highlights the evolution of TDM, its role in optimizing patient outcomes, and emerging techniques such as pharmacodynamic monitoring to further individualize and refine therapeutic regimens.

 

Author (s) Details

 

V. Himabindu
Department of Pharmaceutics, Anurag Pharmacy College (Affiliated to JNTUH, Hyderabad), Kodad, Telangana, India.

 

G. Sangeetha Roy
Department of Pharmacy Practice, Anurag Pharmacy College (Affiliated to JNTUH, Hyderabad), Kodad, Telangana, India.

 

Please see the book here:- https://doi.org/10.9734/bpi/prrat/v9/3134

Advancements in Antibiotic Therapy: The Role and Future Scope of Ceftobiprole as a Fifth-generation Cephalosporin | Chapter 1 | Pharmaceutical Science: New Insights and Developments Vol. 2

The emergence of antibiotic resistance is a critical issue in modern medicine, significantly challenging the effectiveness of current antimicrobial agents. Among these, cephalosporins have played a central role in treating various bacterial infections. However, the rapid evolution of resistant pathogens, including those with extended-spectrum beta-lactamase (ESBL) and carbapenem-resistant mechanisms, necessitates the development of new-generation antibiotics. This chapter focuses on Ceftobiprole, a fifth-generation cephalosporin with potent activity against multidrug-resistant bacteria, including methicillin-resistant Staphylococcus aureus (MRSA) and penicillin-resistant Streptococcus pneumoniae.

Ceftobiprole’s pharmacokinetics and pharmacodynamics underscore its efficacy and safety, demonstrating high tissue penetration and a stable profile in renal excretion, which supports its use in severe infections like complicated skin and soft tissue infections (cSSTIs) and community-acquired pneumonia (CAP). Its mechanism of action involves binding to penicillin-binding proteins (PBPs), especially PBP2a in MRSA, disrupting cell wall synthesis and effectively neutralizing resistant pathogens. Regulatory approvals across Europe, Canada, and additional regions highlight Ceftobiprole's success as a critical therapeutic agent, and ongoing research aims to expand its indications to hospital-acquired infections.

As antibiotic resistance continues to rise, the development of advanced agents like Ceftobiprole is essential. This chapter reviews its clinical applications, history, and evolution, alongside its potential for integration into antimicrobial stewardship programs to mitigate resistance. Ceftobiprole’s broad spectrum and promising efficacy position it as a vital tool for addressing resistant infections, underscoring the importance of continued innovation in antibiotic development.

 

Author (s) Details

 

Hariharan M
Department of Pharmacy Practice, SRM College of Pharmacy, SRM Institute of Science and Technology, Kattankulathur, Chennai 603 203, Tamil Nadu, India.

 

Sankari A
Department of Pharmacy Practice, SRM College of Pharmacy, SRM Institute of Science and Technology, Kattankulathur, Chennai 603 203, Tamil Nadu, India.

 

MG Rajanandh
Department of Pharmacy Practice, SRM College of Pharmacy, SRM Institute of Science and Technology, Kattankulathur, Chennai 603 203, Tamil Nadu, India.

Please see the book here:-https://doi.org/10.9734/bpi/psnid/v2/3531 

Advancements in Therapeutic Drug Monitoring: Integrating Pharmacokinetics, Pharmacodynamics, and Bayesian Approaches for Personalised Medicine | Chapter 6 | Pharmaceutical Research: Recent Advances and Trends Vol. 9

 

Therapeutic drug monitoring (TDM) is a critical process in clinical pharmacology that involves measuring drug concentrations in biological fluids to optimize drug dosage and ensure efficacy while avoiding toxicity. By incorporating pharmacokinetics (PK) and pharmacodynamics (PD) principles, TDM allows for individualized therapy, particularly for drugs with narrow therapeutic indices. Recent advancements, including population pharmacokinetic approaches and Bayesian estimation, have enhanced the precision of TDM. This review highlights the evolution of TDM, its role in optimizing patient outcomes, and emerging techniques such as pharmacodynamic monitoring to further individualize and refine therapeutic regimens.

 

Author(s)details:-

 

V. Himabindu
Department of Pharmaceutics, Anurag Pharmacy College (Affiliated to JNTUH, Hyderabad), Kodad, Telangana, India.

 

G. Sangeetha Roy
Department of Pharmacy Practice, Anurag Pharmacy College (Affiliated to JNTUH, Hyderabad), Kodad, Telangana, India.

 

Please See the book here :-  https://doi.org/10.9734/bpi/prrat/v9/3134