Introduction Pharmacokinetic (PK) parameters are the backbone of drug development. They tell us how a drug moves through the body — how it's absorbed, distributed, broken down, and finally excreted. These details help determine whether a drug is safe and effective. As the pharmaceutical industry grows more competitive, protecting innovations around PK parameters is more important than ever. Companies want exclusive rights to their discoveries, especially when they lead to better drugs or easier manufacturing processes. But patenting PK-related inventions is not simple. Patent disputes are common, and legal battles can slow down or block important breakthroughs. Understanding these challenges helps businesses avoid costly lawsuits and protect their research. Understanding Pharmacokinetic Parameters and Their Role in Drug Development What Are Pharmacokinetic Parameters? PK parameters include measures like absorption rate, distribution volume, metabolism speed, and excretion ...
Comprehensive Guide to the Generic Approval Pathway in the United Arab Emirates Introduction Getting a generic medicine approved in the UAE is a vital process for pharmaceutical companies. It ensures that quality, safety, and effectiveness are upheld for patients. As the UAE’s healthcare system grows, so does the need for quick and clear approval routes for generic drugs. These pathways help decrease healthcare costs while making medicines more accessible. Striking the right balance between safe medicines and affordability is the key goal of the approval process. This guide explains how the UAE approves generics step by step. Understanding the Regulatory Landscape in the UAE Overview of the UAE Ministry of Health and Prevention (MOHAP) The UAE’s main regulator for drugs is MOHAP. It makes sure medicines are safe and effective before they reach the market. It handles registration, quality control, and post-market surveillance. For any pharmaceutical company looking to sell generic...