PDA Comments on Draft Guidance for Industry, ANDAs: Blend Uniformity
PDA, INC. - PDA Journal of Pharmaceutical Science and …, 2000 - journal.pda.org
PDA Comments on Draft Guidance for Industry, ANDAs: Blend Uniformity | PDA Journal of
Pharmaceutical Science and Technology Skip to main content Main menu Home Content Current …
Pharmaceutical Science and Technology Skip to main content Main menu Home Content Current …
[PDF][PDF] PQRI Workshop on Blend Uniformity
JH Timmermans - Pharmaceutical technology, 2001 - alfresco-static-files.s3.amazonaws …
Background PQRI was formed as a collaboration of seven pharmaceutical organizations
(including FDA Center for Drug Evaluation and Research) with a mission to generate …
(including FDA Center for Drug Evaluation and Research) with a mission to generate …
[PDF][PDF] Report on the industry blend uniformity practices survey
G Boehm - Pharmaceutical technology, 2001 - alfresco-static-files.s3.amazonaws …
The Blend Uniformity Working Group was formed by PQRI to assess issues surrounding
blend uniformity testing. As part of this work, the group conducted a survey of …
blend uniformity testing. As part of this work, the group conducted a survey of …
[PDF][PDF] Current events in blend and content uniformity
JS Bergum, JK Prescott, RW Tejwani, TP Garcia… - Pharm …, 2014 - jenike.usmblogs.com
In 1999, the Product Quality Research Institute (PQRI) established the Blend Uniformity
Working Group. The purpose of this group was to make scientifically based …
Working Group. The purpose of this group was to make scientifically based …
Recommendations for the assessment of blend and content uniformity: modifications to withdrawn FDA draft stratified sampling guidance
T Garcia, J Bergum, J Prescott, R Tejwani… - Journal of …, 2015 - Springer
Introduction The following paper describes the International Society for Pharmaceutical
Engineering (ISPE)-sponsored Blend Uniformity and Content Uniformity Group's proposed …
Engineering (ISPE)-sponsored Blend Uniformity and Content Uniformity Group's proposed …
[BOOK][B] Pharmaceutical blending and mixing
Written in four parts, this book provides a dedicated and in-depth reference for blending
within the pharmaceutical manufacturing industry. It links the science of blending with …
within the pharmaceutical manufacturing industry. It links the science of blending with …
[HTML][HTML] Navigating the Regulatory Landscape of Combination Products
A Siew - Pharmaceutical Technology, 2014 - pharmtech.com
While the success and potential of combination products in advancing patient care and
making treatments safer and more effective have contributed to its rapid market growth, the …
making treatments safer and more effective have contributed to its rapid market growth, the …
[PDF][PDF] THE RIGHT MIX
R Pavlik, S Buhajczuk, M Goodin - ansys.com
ANSYS ADVANTAGE Volume IX| Issue 1| 2015 30© 2015 ANSYS, INC. configured for a
variety of end-user mixing applications. The disposable polymer mixing bag is engineered …
variety of end-user mixing applications. The disposable polymer mixing bag is engineered …
Evaluation of blend uniformity and content uniformity based on 2003 stratified sampling guidance and 1999 blend uniformity analysis guidance: product A
M Howard-Sparks, A Gawlikowski - PDA Journal of Pharmaceutical …, 2004 - journal.pda.org
In August 1999 the FDA issued a Draft Abbreviated New Drug Application (ANDA) Guidance
for Industry titled “ANDA's: Blend Uniformity Analysis” that detailed blend uniformity sampling …
for Industry titled “ANDA's: Blend Uniformity Analysis” that detailed blend uniformity sampling …
[HTML][HTML] In Equal Measures: The Importance of Excipient Quality
S Haigney - Pharmaceutical Technology, 2023 - pharmtech.com
Excipients are the ingredients of a therapeutic that change an API into a medicine and
perform roles such as preservatives, diluents, buffers, binders, and drug release controllers …
perform roles such as preservatives, diluents, buffers, binders, and drug release controllers …