Unmet Clinical Needs and TPP
Response 1
An unmet clinical need is a medical niche that the current drug treatments lack the required benefit, cannot treat an existing ailment, and the solutions do not exist. Unmet clinical needs are solved by producing new drugs that offer advantages and benefits that the current drugs do not provide, or the new drugs treat a condition which the old drugs in the market cannot. A TPP there is an essential element during the early development of the drug that meets the unmet clinical needs. TPP helps the manufacturers develop initial tests that help them to clarify whether the drug is fit for purpose, thus allowing the new drug to pass from a bench trial to a bedside trial (Cocco et al., 2020). Medical tests are currently efficient methods and set down guidelines for developing a TPP, making feeling unmet clinical needs challenging.
Response 2
The primary purpose of a TPP is to guide the research and development of a product. The first aspect is the in-house TPP, which steers a product’s development towards specific characteristics that the manufacturer wants to input into the product. The features a TPP aims to achieve are end-user safety, desired product attributes, and efficacy characteristics (WHO, 2020). A TPP also helps the drug manufacturer work within the required market and FDA regulation of new drugs. The regulatory aspect of TPPs is always dependent on product dossiers. Dossiers help regulators such as FDA to determine whether the new drug is safe the patient usage and that its benefits surpass its drawbacks (Gupta, 2018). The dossier also shows the drugs’ contents, and the manufacturing process used in the drug manufacture is accepted in the industry. The TPP has to have a dossier that is in line with the unmet clinical needs that the new drug is to meet.
References
Cocco, P., Ayaz-Shah, A., Messenger, M. P., West, R. M., & Shinkins, B. (2020). Target product profiles for medical tests: A systematic review of current methods. BMC Medicine, 18(1). doi:10.1186/s12916-020-01582-1
Gupta, A. (2018, November 4). Registration dossier of pharmaceuticals. Retrieved from https://www.pharmatutor.org/articles/registration-dossier-pharmaceuticals
WHO. (2020, February 2). Target product profiles. Retrieved from https://www.who.int/research-observatory/analyses/tpp/en/
