Recent blog posts
What is post marketing research?
"What" Series
2 min read
What is post marketing research?
21 December 2023
post marketing research of drugs refers to the research on the use and effect of drugs following a specific research scheme after they are approved for marketing.
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What are adverse drug reactions?
"What" Series
2 min read
What are adverse drug reactions?
19 December 2023
Adverse drug reaction (ADR) refers to the harmful reactions of qualified drugs that are unrelated to the purpose of medication under normal usage and dosage.
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What is withdrawal adverse?
"What" Series
2 min read
What is withdrawal adverse?
18 December 2023
If the drug is discontinued or tapered off too quickly, the body's regulation is disrupted, leading to functional issues, symptom resurgence, and worsened disease, known as withdrawal effects.
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What is pre marketing clinical trial? What is the purpose of pre marketing trials?
"What" Series
2 min read
What is pre marketing clinical trial? What is the purpose of pre marketing trials?
15 December 2023
Pre marketing clinical trials are clinical trials designed to obtain information about the effectiveness and safety of a new drug.
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What is a drug recall? Why are the production, sale and use of drugs suspended?
"What" Series
2 min read
What is a drug recall? Why are the production, sale and use of drugs suspended?
15 December 2023
Drug recall means that drug manufacturers recall drugs that have been sold on the market and have potential safety hazards in accordance with prescribed procedures.
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What are soft drugs?
"What" Series
2 min read
What are soft drugs?
15 December 2023
Soft drugs are pharmaceuticals that are easily metabolized and inactivated.
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What is the difference between a generic drug and an innovator drug?
"What" Series
2 min read
What is the difference between a generic drug and an innovator drug?
8 December 2023
Generic drugs are medications that have been approved by the FDA as equivalent to brand-name drugs in terms of safety, efficacy, and quality.
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What is CBER's role after a biological product is approved and in use?
"What" Series
2 min read
What is CBER's role after a biological product is approved and in use?
8 December 2023
CBER continues to monitor the safety and stability of biological products that have been approved.
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What is the EU Drug Regulatory System?
"What" Series
2 min read
What is the EU Drug Regulatory System?
7 December 2023
The European medicines regulatory system is based on a network of around 50 regulatory authorities from the 30 EEA countries (27 EU Member States plus Iceland, Liechtenstein and Norway), the European Commission and EMA.
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What is dose expansion and why is a dose expansion trial performed?
"What" Series
2 min read
What is dose expansion and why is a dose expansion trial performed?
7 December 2023
Dose expansion trials are clinical trials that evaluate the safety, pharmacokinetics, pharmacodynamics, and clinical activity of a new drug or treatment in a larger group of patients than in the initial dose escalation trial.
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What types of drugs are regulated by CBER?
"What" Series
2 min read
What types of drugs are regulated by CBER?
6 December 2023
CBER, or the Center for Biologics Evaluation and Research, is one Center within the Food and Drug Administration, an Agency within the United States Government's Department of Health and Human Services (HHS).
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What are the advantages of eCRF over CRF?
"What" Series
2 min read
What are the advantages of eCRF over CRF?
6 December 2023
The advantages of eCRF over CRF include:Digital format,Security,Transportation,Ease of use,Flexibility.
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