Cargando…

First-Principles and Empirical Approaches to Predicting In Vitro Dissolution for Pharmaceutical Formulation and Process Development and for Product Release Testing

This manuscript represents the perspective of the Dissolution Working Group of the International Consortium for Innovation and Quality in Pharmaceutical Development (IQ) and of two focus groups of the American Association of Pharmaceutical Scientists (AAPS): Process Analytical Technology (PAT) and I...

Descripción completa

Detalles Bibliográficos
Autores principales:	Zaborenko, Nikolay, Shi, Zhenqi, Corredor, Claudia C., Smith-Goettler, Brandye M., Zhang, Limin, Hermans, Andre, Neu, Colleen M., Alam, Md Anik, Cohen, Michael J., Lu, Xujin, Xiong, Leah, Zacour, Brian M.
Formato:	Online Artículo Texto
Lenguaje:	English
Publicado:	Springer International Publishing 2019
Materias:	White Paper
Acceso en línea:	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6394641/ https://www.ncbi.nlm.nih.gov/pubmed/30790200 http://dx.doi.org/10.1208/s12248-019-0297-y

Ejemplares similares

Pharmaceutical “New Prior Knowledge”: Twenty-First Century Assurance of Therapeutic Equivalence
por: Hussain, Ajaz S., et al.
Publicado: (2019)

Science‐Based Approach to Harmonize Contraception Recommendations in Clinical Trials and Pharmaceutical Labels
por: Bowman, Christopher J., et al.
Publicado: (2022)

NonClinical Dose Formulation Analysis Method Validation and Sample Analysis
por: Whitmire, Monica Lee, et al.
Publicado: (2010)

Physiologically‐Based Pharmacokinetic Modeling in Renal and Hepatic Impairment Populations: A Pharmaceutical Industry Perspective
por: Heimbach, Tycho, et al.
Publicado: (2020)

Scientific and regulatory evaluation of empirical pharmacometric models: An application of the risk informed credibility assessment framework
por: Skottheim Rusten, Ine, et al.
Publicado: (2021)

In and Beyond COVID-19: US Academic Pharmaceutical Science and Engineering Community Must Engage to Meet Critical National Needs
por: Gurvich, Vadim J., et al.
Publicado: (2020)

Consideration of a Credibility Assessment Framework in Model‐Informed Drug Development: Potential Application to Physiologically‐Based Pharmacokinetic Modeling and Simulation
por: Kuemmel, Colleen, et al.
Publicado: (2019)

Directions for research and training in plant omics: Big Questions and Big Data
por: Argueso, Cristiana T., et al.
Publicado: (2019)

Na(+)/Ca(2+) exchange and Na(+)/K(+)-ATPase in the heart
por: Shattock, Michael J, et al.
Publicado: (2015)

Studies on Monitoring and Tracking Genetic Resources: An Executive Summary
por: Garrity, George M., et al.
Publicado: (2009)

Best Practices for the Development, Scale-up, and Post-approval Change Control of IR and MR Dosage Forms in the Current Quality-by-Design Paradigm
por: Van Buskirk, Glenn A., et al.
Publicado: (2014)

Current status of the multinational Arabidopsis community
por: Parry, Geraint, et al.
Publicado: (2020)

Cephalopod genomics: A plan of strategies and organization
por: Albertin, Caroline B., et al.
Publicado: (2012)

General Principles for the Validation of Proarrhythmia Risk Prediction Models: An Extension of the CiPA In Silico Strategy
por: Li, Zhihua, et al.
Publicado: (2019)

Interactive Multimedia Reporting Technical Considerations: HIMSS-SIIM Collaborative White Paper
por: Berkowitz, Seth J., et al.
Publicado: (2022)

Establishing Telemedicine in an Academic Total Joint Arthroplasty Practice: Needs and Opportunities Highlighted by the COVID-19 Pandemic
por: Rao, Sandesh S., et al.
Publicado: (2020)

Arthroplasty during the COVID-19 Pandemic
por: North, Trevor, et al.
Publicado: (2020)

When Can We Rely on Real‐World Evidence to Evaluate New Medical Treatments?
por: Simon, Gregory E., et al.
Publicado: (2021)

When Can We Trust Real‐World Data To Evaluate New Medical Treatments?
por: Simon, Gregory E., et al.
Publicado: (2021)

Converging on child mental health – toward shared global action for child development
por: Belkin, G., et al.
Publicado: (2017)

Modeling Approaches to Reimagine Stability (MARS) for Enabling Earlier Access to Critical Drugs for Patients with Unmet Medical Needs
por: Furness, M. Scott, et al.
Publicado: (2023)

A proposal to sequence the genome of a garter snake (Thamnophis sirtalis)
por: Castoe, Todd A., et al.
Publicado: (2011)

Current Perspectives on Coronavirus Disease 2019 and Cardiovascular Disease: A White Paper by the JAHA Editors
por: Gupta, Ajay K., et al.
Publicado: (2020)

Good Practices in Model‐Informed Drug Discovery and Development: Practice, Application, and Documentation
por: Marshall, SF, et al.
Publicado: (2016)

Thoughtflow: Standards and Tools for Provenance Capture and Workflow Definition to Support Model‐Informed Drug Discovery and Development
por: Wilkins, JJ, et al.
Publicado: (2017)

Applications of Quantitative Systems Pharmacology in Model‐Informed Drug Discovery: Perspective on Impact and Opportunities
por: Bradshaw, Erica L., et al.
Publicado: (2019)

Scientific and regulatory evaluation of mechanistic in silico drug and disease models in drug development: Building model credibility
por: Musuamba, Flora T., et al.
Publicado: (2021)

Advanced Methods for Dose and Regimen Finding During Drug Development: Summary of the EMA/EFPIA Workshop on Dose Finding (London 4–5 December 2014)
por: Musuamba, FT, et al.
Publicado: (2017)

Broadening the impact of plant science through innovative, integrative, and inclusive outreach
por: Friesner, Joanna, et al.
Publicado: (2021)

Meeting Report: 1st International Functional Metagenomics Workshop May 7–8, 2012, St. Jacobs, Ontario, Canada.
por: Engel, Katja, et al.
Publicado: (2013)

Anti-drug Antibody Validation Testing and Reporting Harmonization
por: Myler, Heather, et al.
Publicado: (2021)

Detection of early-universe gravitational-wave signatures and fundamental physics
por: Caldwell, Robert, et al.
Publicado: (2022)

Two genome sequences of the same bacterial strain, Gluconacetobacter diazotrophicus PAl 5, suggest a new standard in genome sequence submission
por: Giongo, Adriana, et al.
Publicado: (2010)

Extending Standards for Genomics and Metagenomics Data: A Research Coordination Network for the Genomic Standards Consortium (RCN4GSC)
por: Wooley, John C., et al.
Publicado: (2009)

Conceptualizing a Genomics Software Institute (GSI)
por: Gilbert, Jack A., et al.
Publicado: (2012)

Passive Transdermal Systems Whitepaper Incorporating Current Chemistry, Manufacturing and Controls (CMC) Development Principles
por: Van Buskirk, Glenn A., et al.
Publicado: (2012)

Implementing the 2009 Institute of Medicine recommendations on resident physician work hours, supervision, and safety
por: Blum, Alexander B, et al.
Publicado: (2011)

The National LGBT Cancer Action Plan: A White Paper of the 2014 National Summit on Cancer in the LGBT Communities
por: Burkhalter, Jack E., et al.
Publicado: (2016)

Approaches to Quality Risk Management When Using Single-Use Systems in the Manufacture of Biologics
por: Ishii-Watabe, Akiko, et al.
Publicado: (2015)

A Blueprint for Telerehabilitation Guidelines
por: Brennan, David, et al.
Publicado: (2010)

Cannot write session to /tmp/vufind_sessions/sess_g4um1ipl4s1vsuutrfiklfju7f