Strategic funding priorities in the pharmaceutical sciences allied to Quality by Design (QbD) and Process Analytical Technology (PAT)
-
Analytical Method Development in the Quality by Design Framework
Pharma Live, , Analytical Discussion, 0
The development of analytical methods in the Quality by Design (QbD) framework is currently gaining great momentum in the...
-
Evaluation of an Automated Solid-Phase Extraction Method Using Positive Pressure
Pharma Live, , Analytical Discussion, 0
Introduction Each year, 1.7 million people in the US are diagnosed with cancer; of these, approximately 580,000 will die...
-
Applying Quality by Design Principles to Analytical Methods to Gain Enhanced Method Understanding
Pharma Live, , Analytical Discussion, 0
Introduction Quality by Design (QbD) concepts described in ICH Q8-101-3 can be applied to understand, reduce, and control sources of...
-
Reversed Phase LC-UV Method Development and Validation for Simultaneous determination of three antiretrovirals: Lamivudine, Zidovudine, Nevirapine and Possible Degradants in a Fixed Dose Pharmaceutical Product
Pharma Live, , Analytical Discussion, 0
Abstract Background: Lamivudine (3TC), Zidovudine (AZT) and Nevirapine (NVP) are the common antiretrovirals prescribed in resource limited countries due to...
-
Fact Sheet New Drug Development Process
Pharma Live, , Formulation Discussion, Uncategorized, 0
Fact Sheet New Drug Development Process At one time or another everyone has relied on prescription drugs to help...
-
REVIEW ON STABILITY INDICATING ASSAY METHODS (SIAMS)
Pharma Live, , Analytical Discussion, 0
ABOUT AUTHORS:Salma S. Quadri*, Lalit V. Sonwane, Bhagwat N. Poul, Sharada N. KamshetteDepartment of Quality Assurance,MSS’s Maharashtra College of...
-
Pharmaceutical impurities and degradation products: Uses and applications of NMR techniques
Pharma Live, , Analytical Discussion, Uncategorized, 0
Abstract Current standards and regulations demand the pharmaceutical industry not only to produce highly pure drug substances, but to...
-