Question

All of these questions are related to my intro to pharmacy class, these are pharmacy questions

what are the primary outcomes of Phase I, II, III and IV clinical trials.

• what biologics are the responsibility of CDER and which are CBER’s responsibility

• how long is the overall steps to the NDA review process

• what does it means to be a part of a double-blinded study

• what is a case report form and adverse event report include

Answer 1

outcomes of clinical trial

phase I - to find out the appropriate dose of the drug with less side effect

phase II - determine the efficacy, side effects and check the drug works or not

phase III - efficacy, safety and effectiveness

phase IV - post marketing surveillance-closely monitor large group of people for drug action(some rare side effects are detected)

CDER responsibility

• Centre for Drug Evaluation and Research
• the main responsibility of CDER is to review the NDA to make sure the safety and efficacy of new drud
• it is coming under FDA
• it monitor the medicines defined in drug and cosmetic act.

CBER Responsibility

• Centre for Biologics Evaluation and Research
• the responsibility include the regulation of biological products intended for human use
• educate the individuals about the safe and effective use of biological products
• ensure the availability of biological products to those who need it

NDA review process

after phase III clinical trial the manufacturer submit the NDA(new drud application) to FDA.

FDA take 60 days to decide whether the provided information is enough for the formal review or not. If the information provided is insufficient they reject the application.

the time required for reviewing will vary depending on the type and nature of drug

the CDER take around 10 months for review.

Double-blinded study

double blinded study means that both the researcher and the patient is unaware about who is getting placebo and who is getting treatment.

it helps to prevent the bias in clinical trial.

Case report form

CRF is a tool used in the clinical trial.

it may be paper or electronic data form used to collect information from the patients.

all information about the participants is recorded in CRF.

it is prepared by the researcher according to the research protocol.

Adverse event report

adverse events are reported by doctors and other health care professionals.

the adverse effect of drugs as well as the devices are reported.

the adverse event report should include;

• description of event
• time of onset of reaction
• details of treatment provided
• demography of patient
• comorbidity and past medical history
• laboratory data
• report about the rechallange and dechallenge of suspected drug.