1. Describe the significance of phase 4 in the process of new drug approval. What is...

1. Describe the significance of phase 4 in the process of new drug approval. What is a goal of postmarketing surveillance (PMS) in a new drug approval process?

Expert Solution

All studies of Phase IV are not study of post-marketing surveillance (PMS) but all study of PMS is a study of phase IV. Phase IV is an essential part of development of drug. In special, the drug efficacy as assesed in an non-interventional, observational test in a naturalistic arrangement that complements the effectiveness of information that emerge from a pre-marketing randomized controlled test (RCT). In man made environment, number of patients are studied pre marketing does'nt matter, the correct drug safety outline is classified by measuring safety surveillance only through a sudden unfavourable event recording system also a post-marketing surveillance.

Frequent pattern of practice can produce causes that could leads to far assesment of a new symptom through the RCT route. Disease reported are other alternatives as the large simple hybrid tests. Investigation of suddenly registered unfavourable events continues as long as product is selled. And hence, in that view Phase IV never ends.

PMS is the exercise of observing the pharmaceutical drug safety after it has been delivered on the market also is an essential part of the pharmacovigilance science.

gladiator answered 1 year ago

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