Nomenclature associated with chemical characterization of and compatibility evaluations for medical product delivery systems
DR Jenke - PDA Journal of Pharmaceutical Science and …, 2003 - journal.pda.org
Delivery systems are used to store, contain, and/or administer liquid pharmaceutical
products. Gaining an understanding of the chemical composition of such a delivery system is …
products. Gaining an understanding of the chemical composition of such a delivery system is …
Design and utilization of the drug–excipient chemical compatibility automated system
VH Thomas, M Naath - International journal of pharmaceutics, 2008 - Elsevier
To accelerate clinical formulation development, an excipient compatibility screen should be
conducted as early as possible and it must be rapid, robust and resource sparing. This …
conducted as early as possible and it must be rapid, robust and resource sparing. This …
[BOOK][B] Compatibility of pharmaceutical solutions and contact materials: safety assessments of extractables and leachables for pharmaceutical products
D Jenke - 2009 - books.google.com
Important safety aspects of compatibility for therapeutic products and their manufacturing
systems, delivery devices, and containers Compatibility of Pharmaceutical Products and …
systems, delivery devices, and containers Compatibility of Pharmaceutical Products and …
Drug-excipient compatibility studies in formulation development: current trends and techniques
The safety, efficacy, quality and stability of a formulation are the cornerstones of any new
drug development process. In order to consistently maintain these attributes in a finished …
drug development process. In order to consistently maintain these attributes in a finished …
Container–Content Compatibility Studies: A Pharmaceutical Team's Integrated Approach
A Laschi, N Sehnal, A Alarcon, B Barcelo… - PDA Journal of …, 2009 - journal.pda.org
Container–content compatibility studies are required as part of the submission of a new
product market authorization file or for a change relating to the primary product-contact …
product market authorization file or for a change relating to the primary product-contact …
[PDF][PDF] IMPORTANCE OF DRUG EXCIPIENT COMPATIBILITY STUDIES BY USING OR UTILIZING OR EMPLOYING VARIOUS ANALYTICAL TECHNIQUES–AN …
R Rajesh, V Navya, SK Kumar - IJPSR, 2022 - researchgate.net
The interaction/incompatibility of drug excipients is a major concern in formulation
generation. Compatibility tests for drug excipients constitute an important step of the …
generation. Compatibility tests for drug excipients constitute an important step of the …
Excipient compatibility and functionality
AS Narang, RV Mantri, KS Raghavan - Developing solid oral dosage forms, 2017 - Elsevier
Excipient selection is based on their functionality, compatibility, and variability of critical
material attributes within an acceptable range for a given drug product. Drug-excipient …
material attributes within an acceptable range for a given drug product. Drug-excipient …
Evaluation of model solvent systems for assessing the accumulation of container extractables in drug formulations
DR Jenke - International journal of pharmaceutics, 2001 - Elsevier
The interaction between a medical device and a pharmaceutical solution it contacts may
dictate solution safety and/or efficacy. Of specific concern is the ability of device components …
dictate solution safety and/or efficacy. Of specific concern is the ability of device components …
[BOOK][B] Compatibility of pharmaceutical products and contact materials: safety considerations associated with extractables and leachables
D Jenke - 2009 - Wiley Online Library
I think it was at the 2005 Extractables and Leachables Forum, sponsored by the PDA, where
someone said those fateful words,“Someone ought to write a book about this stuff”. Having …
someone said those fateful words,“Someone ought to write a book about this stuff”. Having …
A compilation of safety impact information for extractables associated with materials used in pharmaceutical packaging, delivery, administration, and manufacturing …
D Jenke, T Carlson - PDA Journal of Pharmaceutical Science and …, 2014 - journal.pda.org
Demonstrating suitability for intended use is necessary to register packaging,
delivery/administration, or manufacturing systems for pharmaceutical products. During their …
delivery/administration, or manufacturing systems for pharmaceutical products. During their …