Clinical trials is a much specialised area and an important aspect of drug development. It is very intricate and involves several stakeholders and diverse factors that contribute to its study management and timelines. Clinical trials are a long drawn process and to be successful it must meet its objective in the planned timelines. Thus, the entire…
A Reference Listed Drug (RLD) is a brand-name drug developed by an innovator company and officially authorized by regulatory bodies like the U.S. Food and Drug Administration (FDA) to serve as the benchmark for generic copies of the innovator products. The FDA mandates that the generic manufacturers must demonstrate almost similar qualitative and quantitative composition to…
Comparator drugs are required for various reasons in the pharmaceutical industry. A right comparator remains an important participant for various research and development experiments. The researchers spend considerable time to find out the right comparator for their experiments and also try to work out how to obtain the right comparator from the right bonafide source.
The…
Biosimilar are generic copies of the innovator biological products. Biological products are produced from a variety of sources. These include yeasts, bacteria, and animal cells etc. that generate complex biological chemicals from live organisms that have potential use as medicines. Biological products can be produced from variety of biological matter and can have different inventive manufacturing…
The direct to patient (DTP) service is a healthcare model in which medical providers interact and collaborate with patients directly, without the need of typical intermediaries or channels. In order to establish the direct communication channel, Direct To Patient service engages use of technology and personalized communication strategies to strengthen patients and increase access to…
Precision medicine, often referred to as personalized medicine or stratified medicine, is a method of providing customized and individualized healthcare to the patient. This involves customizing medical therapies and specific preventative strategies to meet the unique needs of each patient by taking into account individual variances in genes, lifestyle, and environment. Precision treatment takes into…
Generic drugs are canopies on the original innovator brands available once the patent of the innovators cease to exist. Generic medicinal products need to prove themselves of being bioequivalent to the original brand for making themselves available in the market. They are identical to their branded equivalents in terms of active components, dosage form, potency,…
Direct-to-patient shipments, also known as direct-to-consumer or direct-to-patient delivery, are the processes of delivering healthcare supplies or pharmaceutical products directly to the patients under a specific bonafide scheme. Direct-to-patient shipments have received a lot of attention in recent years, thanks to technological improvements, changes in healthcare legislation, and a growing need for personalized and patient-centric…
Few illnesses such as post major surgeries, oral surgeries and critical illnesses prohibit taking food orally. In these situations, the nutritional support for the patients is given externally. Enteral feeding tubes are medical devices that provide nutrition directly into the gastrointestinal system of the patients. They are typically employed when the patient's oral intake is restricted…
Intermittent drug shortages are not new, but currently they have become more severe as a result of the pandemic and other recent global events. This is making it difficult for many patients to get the medications they require. Sometimes, the access to the medicines does not exist as the required medicines are not yet licensed…
Rare diseases are rare in their occurrence and affect a small population in the community. These uncommon, usually serious, incapacitating, chronic, and lethal diseases are categorized as rare and/ or orphan diseases. Only a small portion of the population is afflicted with such rare diseases. There is no universal agreement on the threshold at…
The definition of rare diseases or rare health conditions in different nations is based on the disease prevalence and the national population. The word rare signifies that a particular disease or an ailment is not a common occurrence. Therefore, the most common criteria i.e. frequency of the disease with respect to the population is usually…