Regulatory affairs / Software Excels
by samitfm · Published December 6, 2024 · Last modified January 8, 2025
Regulatory Submission Software:Ultimate Guide in the Pharmaceuticals Introduction to Regulatory Submission Software Regulatory Submission Software: In the highly regulated life sciences sector, regulatory submission software has become an essential tool for companies aiming to...
An Overview of Randomization Techniques for Clinical Trials What is Randomization? Randomization is the method of assigning participants to different groups in Clinical Trials , such as treatment and control groups, ensuring each participant...
Randomization Schedules Generating Using SAS Programming language Randomization is a widely utilized method for experimental control in clinical trials. Creating a randomization schedule is a crucial aspect of certain trials. This discussion covers the...
News Articles / Software Excels
by samitfm · Published June 12, 2024 · Last modified January 8, 2025
GAMP 5: Concept of GAMP 5 in Pharmaceuticals GAMP-5 Good Automated Manufacturing Practice consists of guidelines aimed at both users and manufacturers of automated pharmaceutical products. Established in 1991 by professionals in the UK...
News Articles / SAS / Software Excels
by samitfm · Published April 15, 2024 · Last modified January 9, 2025
Free Pharmacokinetic Software & Excels used in PK/PD analysis-10+ What is PK/PD Analysis Free Pharmacokinetic Software & Excels used in PK/PD analysis is pharmacokinetics (PK) refers to the process of how drugs move within...
Accumulation: Understanding Its Significance and Methods for Calculation Accumulation Michael requested a discussion on the concept of accumulation, a term commonly encountered in both nonclinical and clinical contexts. While some individuals approach this term...
Estimate of pharmacokinetic parameters. From non-Compartmental data using -Microsoft Excel-24 Estimate of pharmacokinetic parameters (CDISC) using Microsoft Excel-estimation , Pharmacokinetic parameters, such as clearance (CL) and volume of distribution (V), represent constants that vary...
Overview of statistical concepts-Bioequivalence Pharmacokinetics INTRODUCTION Overview-of-statistical-concepts-bioequivalence, Current global regulatory agencies mandate that the final assessment of an oral medication\’s quality relies on its in vitro dissolution behavior, along with in vivo bioavailability and/or...
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...
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...
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At Zaims Pharma, we focus on the intersection of pharmaceutical regulations, compliance standards, and the transformative power of technology. Our team is passionate about simplifying the complexities of the industry, whether through in-depth articles, expert interviews, regulatory updates, or software solution reviews. We provide valuable tools and actionable insights that help our readers navigate the evolving landscape of pharmaceuticals and healthcare.
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