Nitrosamine USFDA Guidelines: Managing Nitrosamine Contaminants in Human Medications Nitrosamine Earlier today (September 4, 2024), the Center for Drug Evaluation and Research of the U.S. Food and Drug Administration issued an updated version of...
SAHPRA South Africa: eCTD Compliance and Technical Review for Renewal Applications – Template SAHPRA South Africa The South African Health Products Regulatory Authority (SAHPRA) has issued new instructions for \”eCTD Validation and Technical Screening...
USFDA Guidance: Incorporating Voluntary Patient Preference Information Throughout the Product Life Cycle The USFDA Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) have issued a draft...
News Articles / Pharmaceutical engineering
by samitfm · Published August 9, 2024 · Last modified December 30, 2024
Research and Development in the Pharmaceutical Industry Research and development in the pharmaceutical industry is an intricate and exciting path from idea to implementation. It’s the intersection of science and innovation, leading to significant...
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 / Pharmaceutical engineering
by samitfm · Published August 7, 2024 · Last modified January 8, 2025
3D Printing technology in Pharmaceuticals 3D Printing technology in Pharmaceuticals: Additive manufacturing, commonly known as 3D printing, is making significant strides in the pharmaceutical sector. This innovative technology allows for the creation of complex...
News Articles / Regulatory affairs
by samitfm · Published August 6, 2024 · Last modified January 8, 2025
What is Good Laboratory Practice (GLP) Good Laboratory Practice (GLP): The Principles of Good Laboratory Practice (GLP) set forth guidelines and standards for a quality system that manages the processes and conditions involved in...
Akums Drugs and Pharma shares surge by 7% after listing. Should you buy, sell, or hold? Akums Drugs Shares Akums Drugs Shares of Akum Drugs & Pharmaceuticals had a subdued debut on Dalal Street...
Regulatory Concepts Basic terminology,Guidelines, Regulations Regulatory Concepts Investigational Product Guidelines, Regulations Regulatory Concepts A newly developed medication created by a manufacturer.Basic terminology Phase III Clinical Study A randomized trial conducted by the manufacturer to...
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