Cargando…

A Critical Overview of FDA and EMA Statistical Methods to Compare In Vitro Drug Dissolution Profiles of Pharmaceutical Products

A drug dissolution profile is one of the most critical dosage form characteristics with immediate and controlled drug release. Comparing the dissolution profiles of different pharmaceutical products plays a key role before starting the bioequivalence or stability studies. General recommendations for...

Descripción completa

Detalles Bibliográficos
Autores principales:	Muselík, Jan, Komersová, Alena, Kubová, Kateřina, Matzick, Kevin, Skalická, Barbora
Formato:	Online Artículo Texto
Lenguaje:	English
Publicado:	MDPI 2021
Materias:	Article
Acceso en línea:	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8539859/ https://www.ncbi.nlm.nih.gov/pubmed/34683995 http://dx.doi.org/10.3390/pharmaceutics13101703

Ejemplares similares

3D-Printed Coating of Extended-Release Matrix Tablets: Effective Tool for Prevention of Alcohol-Induced Dose Dumping Effect
por: Skalická, Barbora, et al.
Publicado: (2021)

Matrix Tablets Based on Chitosan–Carrageenan Polyelectrolyte Complex: Unique Matrices for Drug Targeting in the Intestine
por: Komersová, Alena, et al.
Publicado: (2022)

The Biosimilar Landscape: An Overview of Regulatory Approvals by the EMA and FDA
por: Gherghescu, Ioana, et al.
Publicado: (2020)

The effect of alcohol on ionizing and non-ionizing drug release from hydrophilic, lipophilic and dual matrix tablets
por: Lochař, Václav, et al.
Publicado: (2020)

Expanded Access as a source of real‐world data: An overview of FDA and EMA approvals
por: Polak, Tobias B., et al.
Publicado: (2020)

Overview of the Side-Effects of FDA- and/or EMA-Approved Targeted Therapies for the Treatment of Hematological Malignancies
por: Constantinescu, Catalin, et al.
Publicado: (2020)

Exploration of Neusilin(®) US2 as an Acceptable Filler in HPMC Matrix Systems—Comparison of Pharmacopoeial and Dynamic Biorelevant Dissolution Study
por: Bílik, Tomáš, et al.
Publicado: (2022)

Regulatory approval of pharmaceuticals without a randomised controlled study: analysis of EMA and FDA approvals 1999–2014
por: Hatswell, Anthony J, et al.
Publicado: (2016)

Lutathera(®): The First FDA- and EMA-Approved Radiopharmaceutical for Peptide Receptor Radionuclide Therapy
por: Hennrich, Ute, et al.
Publicado: (2019)

EMA-FDA Parallel Scientific Advice: Optimizing Development of Medicines in the Global Age
por: Thor, Shannon, et al.
Publicado: (2023)

FDA and EMA Approvals of New Breast Cancer Drugs—A Comparative Regulatory Analysis
por: Leo, Chandra P., et al.
Publicado: (2020)

First COVID-19 Vaccines Receiving the US FDA and EMA Emergency Use Authorization
por: Fortner, Andra, et al.
Publicado: (2021)

Elements of Regulatory Dissonance: Examining FDA and EMA Product Labeling of New Vaccines (2006–2018)
por: Seo, Yurim, et al.
Publicado: (2020)

Evaluation of the draft guidelines proposed by EMA and FDA for the clinical diagnosis of acute uncomplicated cystitis in women
por: Alidjanov, Jakhongir F., et al.
Publicado: (2019)

EMA and FDA psychiatric drug trial guidelines: assessment of guideline development and trial design recommendations
por: Boesen, Kim, et al.
Publicado: (2021)

Considering Global Development? Insights from Applications for FDA Breakthrough Therapy and EMA PRIME Designations
por: Hanaizi, Zahra, et al.
Publicado: (2022)

Necessity of strengthening the current clinical regulatory for companion diagnostics: An institutional comparison of the FDA, EMA, and MFDS
por: Kang, Su Lim, et al.
Publicado: (2023)

New Halogen-Containing Drugs Approved by FDA in 2021: An Overview on Their Syntheses and Pharmaceutical Use
por: Benedetto Tiz, Davide, et al.
Publicado: (2022)

Process of drug registration in Israel: the correlation between the number of discussions within the Ministry of Health and postapproval variations by EMA and/or FDA
por: Hiayev, Stephany, et al.
Publicado: (2023)

Scaffold Searching of FDA and EMA-Approved Drugs Identifies Lead Candidates for Drug Repurposing in Alzheimer’s Disease
por: Shityakov, Sergey, et al.
Publicado: (2021)

The impact of FDA and EMA regulatory decision-making process on the access to CFTR modulators for the treatment of cystic fibrosis
por: Costa, Enrico, et al.
Publicado: (2022)

Initial and supplementary indication approval of new targeted cancer drugs by the FDA, EMA, Health Canada, and TGA
por: Michaeli, Daniel Tobias, et al.
Publicado: (2022)

Association between FDA and EMA expedited approval programs and therapeutic value of new medicines: retrospective cohort study
por: Hwang, Thomas J, et al.
Publicado: (2020)

A Comparison of EMA and FDA Decisions for New Drug Marketing Applications 2014–2016: Concordance, Discordance, and Why
por: Kashoki, Mwango, et al.
Publicado: (2019)

Postmarketing studies for novel drugs approved by both the FDA and EMA between 2005 and 2010: a cross-sectional study
por: Zeitoun, Jean-David, et al.
Publicado: (2017)

A Disability Bioethics Reading of the FDA and EMA Evaluations on the Marketing Authorisation of Growth Hormone for Idiopathic Short Stature Children
por: Murano, Maria Cristina
Publicado: (2020)

Availability of Authorizations from EMA and FDA for Age-Appropriate Medicines Contained in the WHO Essential Medicines List for Children 2019
por: delMoral-Sanchez, Jose-Manuel, et al.
Publicado: (2020)

EMA : escala multidimensional de asertividad : manual /
por: Flores Galaz, Mirta Margarita
Publicado: (2004)

Ema, la cautiva
por: Aira, César, 1949-

A Comprehensive Map of FDA-Approved Pharmaceutical Products
por: Zhong, Hao, et al.
Publicado: (2018)

Entering First-in-Human Clinical Study With a Single-Strain Live Biotherapeutic Product: Input and Feedback Gained From the EMA and the FDA
por: Paquet, Jeanne-Céleste, et al.
Publicado: (2021)

Earth-friendly-assessed silver-nanoparticles spectrophotometric method for rapid and sensitive analysis of Molnupiravir, an FDA-approved candidate for COVID-19: application on pharmaceutical formulation and dissolution test
por: Mohamed, Ahmed R., et al.
Publicado: (2023)

Changes in the Review Period of Drug Application and a Drug Lag from the FDA and the EMA: An Industry Survey in South Korea Between 2011 and 2020
por: Choi, Hyeyoung, et al.
Publicado: (2022)

Keyboard and display for EMAS system
por: Ollenhauer, F
Publicado: (1974)

Drugs, Devices, and the FDA: Part 2: An Overview of Approval Processes: FDA Approval of Medical Devices
por: Van Norman, Gail A.
Publicado: (2016)

Rational Design of Self-Emulsifying Pellet Formulation of Thymol: Technology Development Guided by Molecular-Level Structure Characterization and Ex Vivo Testing
por: Macku, Jan, et al.
Publicado: (2022)

Structural Changes of Sodium Warfarin in Tablets Affecting the Dissolution Profiles and Potential Safety of Generic Substitution
por: Muselík, Jan, et al.
Publicado: (2021)

The FDA guidance for industry on PROs: the point of view of a pharmaceutical company
por: Arpinelli, Fabio, et al.
Publicado: (2006)

First-Principles and Empirical Approaches to Predicting In Vitro Dissolution for Pharmaceutical Formulation and Process Development and for Product Release Testing
por: Zaborenko, Nikolay, et al.
Publicado: (2019)

FDA- and EMA-Approved Tyrosine Kinase Inhibitors in Advanced EGFR-Mutated Non-Small Cell Lung Cancer: Safety, Tolerability, Plasma Concentration Monitoring, and Management
por: Solassol, Isabelle, et al.
Publicado: (2019)

Cannot write session to /tmp/vufind_sessions/sess_kq37ie0tuh2hsi1fsrfh4be2ol