Recently, a few clinical trial sponsors approached us because they were facing a challenge in distinguishing between a genuine and counterfeit pack of an Immuno-Oncology Drug.
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.…
Imagine a scenario where your clinical trial team orders a reference-listed drug with an approved shelf life of 24 to 36 months. However, when it reaches a clinical trial site, you have an RLD with less than 12 months to use.
Case in Point
Pertaining to a recent case involving an immuno-oncology blockbuster. Despite its…
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…
Introduction of Drug Development Process
The development of medicines is a long process that involves several steps and stages. The drug development takes approximately 10 to 15 years. This includes the time from the initial discovery of a molecule to FDA approval, covering time spent in a market release. It's not only time-consuming but…
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 approach to…
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 temperature-sensitive 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…
The success rate of clinical trials depends on a systematically controlled management of clinical trial supplies. Apart from managing many other important activities for the success of a clinical trial program, efficient clinical trial supply management is a prerequisite for getting reliable research outcomes.
Let's know in depth about this one of the most crucial…
A New Chemical Entity (NCE) minus 1 filing, also known as a paragraph IV filing, is a type of application submitted to the U.S. Food and Drug Administration (FDA) for a new drug that represents a slight modification of an existing approved drug. The term "minus 1" indicates that the NCE is only one small…
A New Chemical Entity (NCE) refers to the discovery of new compound in the pharmaceutical industry. This compound has a novel structure, possibly a new chemical class that the innovator has discovered. NCE also implies that such a compound is entirely new and has never been approved for medical use by any regulatory authority worldwide.…