News Articles / Pharmaceutical engineering
by samitfm · Published February 25, 2024 · Last modified January 10, 2025
Production Department in Pharmaceutical Industry Production Department-The process of Drug Manufacturing performed in Production Department in Pharmaceutical Unit into a series of unit operations, such as dispensing, granulation, coating, tablet pressing, blistering, mixing, filling,...
How SAS v4 using For Bioequivalence Data analysis SAS Bioequivalence data analysis-SAS SAS is commonly employed in the analysis of bioequivalence (BE) data. On the other hand, R, a freely available open-source software for...
News Articles / Regulatory affairs
by samitfm · Published February 2, 2024 · Last modified January 10, 2025
Regulatory response & Quality Trends for 2024 Regulatory response :ICH Q9 Quality Risk Management Regulatory response in 2023, significant changes have impacted drug manufacturers, particularly with the revised ICH Q9 guidance on quality risk...
News Articles / Pharmaceutical engineering
by samitfm · Published January 28, 2024 · Last modified December 30, 2024
WHAT IS PHARMACEUTICAL ENGINEERING? Pharmaceutical Engineering & Designing of Drug-2024 : The origins of pharmaceuticals can be traced back to the 1500s, marked by the creation of the first list of drugs and their...
News Articles / Pharmaceutical engineering
by samitfm · Published January 27, 2024 · Last modified January 10, 2025
Labeling and packaging in regulatory affairs? Labeling and packaging role in regulatory affairs: Labeling and packaging play a crucial role in regulatory affairs, adding artistic elements to product presentation while serving as essential components...
News Articles / Regulatory affairs
by samitfm · Published January 26, 2024 · Last modified January 9, 2025
What is Guidelines of TGA on Combination Products & Boundary 2024? TGA on Combination Products & Boundary guidelines TGA : What is Guidelines of TGA on Combination Products & Boundary, The Therapeutic Goods Administration...
News Articles / Regulatory affairs
by samitfm · Published January 22, 2024 · Last modified January 9, 2025
How To Submission Of ANDA To USFDA Regulatory, 2024 ANDA Application Submitting an Abbreviated New Drug Application (ANDA) to the US Food and Drug Administration (USFDA) involves several key steps: 2024 Submission Of ANDA...
Clinical Research / News Articles
by samitfm · Published January 21, 2024 · Last modified December 25, 2024
What is Clinical Trials Phases in Clinical Research? clinical-trials-phase involve the examination of a new drug or treatment within a small group of healthy volunteers. The primary objectives include assessing safety, determining the dosage...
What is Statistical-analysis-system (SAS) in Clinical SAS What-is-statistical-analysis-system (SAS)-procedures encompass prewritten programs designed to execute specific tasks. Noteworthy procedures, such as PROC MEANS for summarizing statistics, PROC FREQ for frequency analysis, and PROC REG...
Clinical Research / News Articles
by samitfm · Published January 20, 2024 · Last modified January 8, 2025
What is Clinical Research & Clinical Trials? What is Clinical research is a specialized field within medical science dedicated to examining the safety and efficacy of medications, devices, diagnostic products, and treatment plans designed...
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