Blood cancer affects millions of people worldwide, creating a challenging situation. A study predicts that in 2025, 66,890 new cancer cases and 23,540 cancer deaths will occur in the United States due to leukemia.
Decentralized Clinical Trials (DCTs) have transformed how clinical trials are conducted. This makes the clinical trial process more flexible and patient-friendly. This minimizes the requirement of participants to visit a trial site frequently. DCTs use technology to manage trials at remote locations with high efficiency, effectively managing clinical trial supply at different locations.…
Comparator drugs play a pivotal role in determining the quality, efficacy, and safety of the generic drug. It acts as a standard drug that will be used to compare the generic copies. It is essential to source the right comparator drug from genuine manufacturers, as there are many challenges in this process. Comparator sourcing can…
Bringing a new drug to market is not a straight path — it’s a long, highly regulated journey filled with scientific testing, regulatory reviews, and careful safety evaluations. The drug development process typically takes 10 to 15 years and can cost over $2.6 billion before a single medicine reaches patients.
From early laboratory discovery to…
The drug development process is quite complex, consisting of numerous steps. This includes discovering the drug, developing dosage forms, conducting research, carrying out clinical trials, seeking approval, and commercializing the drug. Drug development processes also require adherence to authorities like the FDA (Food and Drug Administration) and EMA (European Medicines Agency).
This streamlined…
Managing the storage, distribution, and supply chain of pharmaceutical products requiring special storage conditions is very crucial. This stage ensures the integrity, efficacy, and safety of pharmaceutical products for marketing, as well as products that are to be used for clinical trial supply. Efficient cold-chain management is needed for shipping pharmaceutical products from manufacturers to…
Managing clinical trial supplies isn’t just a behind-the-scenes task—it plays a crucial role in ensuring that trials run smoothly and successfully. From sourcing the right drugs to maintaining the safety of temperature-sensitive materials during transit, every step is critical.
In this guide, we’ll walk you through how to manage clinical trial supplies efficiently,…
What Is NCE-1 and How Does It Work?
New Chemical Entity (NCE-1) is an application submitted to the U.S. Food and Drug Administration (FDA) for a new drug. This process is also known as a paragraph IV filing. The NCE-1 drug represents a slight modification of an existing approved drug. The term “minus 1” implies…
What is a New Chemical Entity (NCE)?
A New Chemical Entity (NCE) represents a significant milestone in pharmaceutical science. It is a new chemical compound that has never before been approved for human therapeutic use by any regulatory authority worldwide.
According to the U.S. Food and Drug Administration, an NCE is defined as a novel…
A tablet is a pharmaceutical oral dosage form containing medicinal substances, with or without additional ingredients. According to the Indian Pharmacopoeia, pharmaceutical tablets are solid, flat, or biconvex units created by compressing drugs or a mixture of drugs, with or without diluents. These tablets come in various shapes, sizes, colors and weights, which depend on…