Cargando…

Influence of Inter- and Intra-Batch Variability on the Sample Size Required for Demonstration of Equivalent Microstructure of Semisolid Dosage Forms

Inter- and intra-batch variability of the quality attributes contribute to the uncertainty for demonstrating equivalent microstructure of post-approval changes and generic/hybrids of semisolid topical products. Selecting a representative sample size to describe accurately the in vitro properties of...

Descripción completa

Detalles Bibliográficos
Autores principales:	Xu, Zhengguo, Mangas-Sanjuán, Víctor, Merino-Sanjuán, Matilde, Merino, Virginia, García-Arieta, Alfredo
Formato:	Online Artículo Texto
Lenguaje:	English
Publicado:	MDPI 2020
Materias:	Article
Acceso en línea:	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7760601/ https://www.ncbi.nlm.nih.gov/pubmed/33260792 http://dx.doi.org/10.3390/pharmaceutics12121159

Ejemplares similares

Assessment of the Inter-Batch Variability of Microstructure Parameters in Topical Semisolids and Impact on the Demonstration of Equivalence
por: Mangas-Sanjuán, Víctor, et al.
Publicado: (2019)

Erratum: Mangas-Sanjuán, V.; et al. Assessment of the Inter-Batch Variability of Microstructure Parameters in Topical Semisolids and Impact on the Demonstration of Equivalence. Pharmaceutics 2019, 11, 503
por: Mangas-Sanjuán, Víctor, et al.
Publicado: (2020)

Regulatory Requirements for the Development of Second-Entry Semisolid Topical Products in the European Union
por: García-Arieta, Alfredo, et al.
Publicado: (2023)

Current Evidence, Challenges, and Opportunities of Physiologically Based Pharmacokinetic Models of Atorvastatin for Decision Making
por: Reig-López, Javier, et al.
Publicado: (2021)

Semisolid Dosage
por: Lunter, Dominique Jasmin, et al.
Publicado: (2020)

Population Pharmacokinetic/Pharmacodynamic Modelling of Daptomycin for Schedule Optimization in Patients with Renal Impairment
por: García-Martínez, Teresa, et al.
Publicado: (2022)

Impact of Pharmacokinetic and Pharmacodynamic Properties of Monoclonal Antibodies in the Management of Psoriasis
por: Rodríguez-Fernández, Karine, et al.
Publicado: (2022)

Complying with the Guideline for Quality and Equivalence for Topical Semisolid Products: The Case of Clotrimazole Cream
por: Alves, Teresa, et al.
Publicado: (2021)

Physiologically-Based Pharmacokinetic/Pharmacodynamic Model of MBQ-167 to Predict Tumor Growth Inhibition in Mice
por: Reig-López, Javier, et al.
Publicado: (2020)

Roles of the semisolid heating on the microstructure of a hypereutectic Al–Fe–Cu alloy
por: Wang, Wei, et al.
Publicado: (2021)

Topical Amphotericin B Semisolid Dosage Form for Cutaneous Leishmaniasis: Physicochemical Characterization, Ex Vivo Skin Permeation and Biological Activity
por: Berenguer, Diana, et al.
Publicado: (2020)

Microstructural Evolution during DPRM Process of Semisolid Ledeburitic D2 Tool Steel
por: Mohammed, M. N., et al.
Publicado: (2013)

Effect of Semisolid and Heat Treatment Process on Microstructural Refinement of Al–7Si Alloy
por: Gebril, Mohamed Abdelgawad, et al.
Publicado: (2023)

Nanotechnology in Wound Healing; Semisolid Dosage Forms Containing Curcumin-Ampicillin Solid Lipid Nanoparticles, in-Vitro, Ex-Vivo and in-Vivo Characteristics
por: Ghaffari, Solmaz, et al.
Publicado: (2018)

Interdependence of Dosage Form Microstructure and Performance
por: Axel Zeitler, J., et al.
Publicado: (2017)

Erratum to "Nanotechnology in Wound Healing; Semisolid Dosage Forms Containing Curcumin-Ampicillin Solid Lipid Nanoparticles, in Vitro, Ex Vivo and in Vivo Characteristics"
por: Ghaffari, Solmaz, et al.
Publicado: (2021)

Alternative Pharmacokinetic Metrics in Single-Dose Studies to Ensure Bioequivalence of Prolonged-Release Products at Steady State—A Case Study
por: Mangas-Sanjuán, Víctor, et al.
Publicado: (2023)

In vitro assessment of inter and intra batch variability of a breath-enhanced jet nebulizer
por: Rehman, Mariam, et al.
Publicado: (2013)

Synthesis and Utilization of Nitroalkyne Equivalents in Batch and Continuous Flow
por: Morse, Peter D., et al.
Publicado: (2017)

Inter- and intramolecular enantioselective carbolithiation reactions
por: Gómez-SanJuan, Asier, et al.
Publicado: (2013)

Pilot Equivalence Study Comparing Different Batches of Topical 0.025% Capsaicin Emulsion: Product Microstructure, Release, and Permeation Evaluation
por: Navarro-Pujol, Francesc, et al.
Publicado: (2021)

Pharmaceutical Equivalence of Clarithromycin Oral Dosage Forms Marketed in Nairobi County, Kenya
por: Manani, Rebecca O., et al.
Publicado: (2017)

Semisolid Metal Processing Techniques for Nondendritic Feedstock Production
por: Mohammed, M. N., et al.
Publicado: (2013)

Growth of B-lymphocytes clones in semisolid culture is mitogen dependent
Publicado: (1976)

In Vitro Permeation of Micronized and Nanonized Alaptide from Semisolid Formulations
por: Opatrilova, Radka, et al.
Publicado: (2013)

QbD-Based Investigation of Dermal Semisolid in situ Film-Forming Systems for Local Anaesthesia
por: Kovács, Anita, et al.
Publicado: (2020)

Investigation of Silicone-Containing Semisolid in Situ Film-Forming Systems Using QbD Tools
por: Kis, Nikolett, et al.
Publicado: (2019)

The Role of Mathematical Models in Immuno-Oncology: Challenges and Future Perspectives
por: Sancho-Araiz, Aymara, et al.
Publicado: (2021)

Mechanism of Fatigue Induced by Different Cycling Paradigms With Equivalent Dosage
por: Hsu, Miao-Ju, et al.
Publicado: (2020)

Semisolid Microstructural Evolution during Partial Remelting of a Bulk Alloy Prepared by Cold Pressing of the Ti-Al-2024Al Powder Mixture
por: Qin, Yahong, et al.
Publicado: (2016)

Effects of Zn Contents on Microstructure and Mechanical Properties of Semisolid Rheo-Diecasting Al-xZn-2Mg-1.5Cu Alloys
por: Hou, Saiheng, et al.
Publicado: (2022)

Occurrence of foodborne pathogens in Italian soft artisanal cheeses displaying different intra- and inter-batch variability of physicochemical and microbiological parameters
por: Pasquali, Frédérique, et al.
Publicado: (2022)

Quality Improvement Project to Evaluate Discharge Prescriptions in Children With Cystic Fibrosis
por: Merino Sanjuán, Matilde, et al.
Publicado: (2019)

Effect of Semisolid Formulation of Persea Americana Mill (Avocado) Oil on Wound Healing in Rats
por: de Oliveira, Ana Paula, et al.
Publicado: (2013)

RE: Evaluating the Semisolid Thyroid Nodules with the Diffusion Weighted Imaging Tool
por: Cuce, Ferhat, et al.
Publicado: (2013)

Biopharmaceutical Study of Triamcinolone Acetonide Semisolid Formulations for Sublingual and Buccal Administration †
por: Márquez Valls, Marta, et al.
Publicado: (2021)

Semisolid Al–Ga composites fabricated at room temperature for hydrogen generation
por: Yu, Yang, et al.
Publicado: (2020)

Simultaneous Salmonella and bacteriophage isolation on Modified Semisolid Rappaport Vassiliadis media
por: Torres-Boncompte, Jan, et al.
Publicado: (2023)

Wide intra- and inter-country variability in drug use and dosage in very-low-birth-weight newborns with severe infections
por: Pandolfini, Chiara, et al.
Publicado: (2012)

Demonstration of Equivalence of Generic Glatiramer Acetate and Copaxone(®)
por: Lipsky, Peter, et al.
Publicado: (2021)

Cannot write session to /tmp/vufind_sessions/sess_66lm6vp3p33oegs9044ocqnsph