Which Phase Of Testing Is Followed With Presenting The Drug For Marketing Authorisation To The FDA For Approval?

Which Phase Of Testing Is Followed With Presenting The Drug For Marketing Authorisation To The FDA For Approval? Phase 3 studies (typically involve several hundred to about 3,000 people). The pre-NDA period, just before a new drug application (NDA) is submitted. A common time for the FDA and drug sponsors to meet. Submission of an

Why Do Research Studies Fail?

Why Do Research Studies Fail? Failures can arise from a lack of efficacy, issues with safety, or a lack of funding to complete a trial, as well as other factors such as failing to maintain good manufacturing protocols, failing to follow FDA guidance, or problems with patient recruitment, enrollment, and retention. Why do Phase 1

Which Is Better Case Control Or Cohort Studies?

Which Is Better Case Control Or Cohort Studies? Cohort studies can be retrospective or prospective. Retrospective cohort studies are NOT the same as case-control studies. … Therefore, cohort studies are good for assessing prognosis, risk factors and harm. The outcome measure in cohort studies is usually a risk ratio / relative risk (RR). Why is

What Is The Strength Of A Randomized Trial?

What Is The Strength Of A Randomized Trial? The strength of the RCT rests on its excellent internal validity, which is based largely on the power of randomisation to ensure that the only difference between two treatment arms is their exposure to the treatment of interest. What makes a good Randomised control trial? All RCTs

What Are The Benefits And Risks Of Using Stem Cells?

What Are The Benefits And Risks Of Using Stem Cells? The risks to research participants undergoing stem cell transplantation include tumour formation, inappropriate stem cell migration, immune rejection of transplanted stem cells, haemorrhage during neurosurgery and postoperative infection. What are the risks of using stem cells? The risks to research participants undergoing stem cell transplantation

Why Is Cancer Study Important?

Why Is Cancer Study Important? The goal of studying cancer is to develop safe and effective methods to prevent, detect, diagnose, treat, and, ultimately, cure the collections of diseases we call cancer. The better we understand these diseases, the more progress we will make toward diminishing the tremendous human and economic tolls of cancer. Why

What Does Blinding Do In A Study?

What Does Blinding Do In A Study? Blinding, in research, refers to a practice where study participants are prevented from knowing certain information that may somehow influence them—thereby tainting the results. What is the purpose of randomization and blinding in research studies? What is the purpose of randomization and blinding in research studies? Both randomization