What is USFDA Tentative Approval?
If a generic drug product is ready for approval before the expiration of any patents or exclusivities accorded to the reference listed drug product, FDA... Read More
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How to calculate compound annual growth rate (CAGR)?
Posted on29 Feb 2024
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The compound annual growth rate (CAGR) is a useful measure of growth over multiple time periods. It can be thought of as the growth rate... Read More
What is 351(k) biologics license application (BLA)?
Posted on29 Feb 2024
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351(k) biologics license application is the biosimilar application process in USFDA. Manufacturers must submit 351(k) biologics license application (BLA) to have a product reviewed as a... Read More
What are the key factors which affect royalty rate in pharmaceutical industry?
Determining the ideal royalty payment in the pharmaceutical industry is complex and depends on various factors. Some key considerations include: Market Value: The perceived value... Read More
How much is the ideal royalty payment in pharmaceutical industry?
A royalty payment is made to the legal owner of the property, patent, copyrighted work, or franchise by licensees or franchisees who wish to make... Read More
What is the meaning of Masking or Blinding?
A clinical trial design strategy in which one or more parties involved in the trial, such as the investigator or participants, do not know which... Read More
What is the meaning of me-too or follow on drugs?
Posted on22 Feb 2024
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Me-too drugs and Follow on drugs are the common terminologies which used by pharmaceutical marketer. A compound that is structurally very similar to already known... Read More
12 Skills what Product Manager should have!
Product managers play a crucial role in driving the success of a product. They need a diverse set of skills to navigate the complex and... Read More
What is the meaning of PIVOTAL TRIAL?
A pivotal trial can refer to a clinical trial or study intended to provide evidence for a drug marketing approval, e.g. by the US FDA.... Read More
What is difference between CAPEX and OPEX in business?
These are the two useful terminology what a strategic management professionals in pharma business. Capital expenditures (CAPEX or capex) are expenditures altering the future of... Read More
Case Study: Product Recall due to labeling error
In the pharmaceutical market we find many cases where product recall takes place due to labeling error. Here is an example. Company XYZ is voluntarily... Read More
What is a Stability-indicating assay method?
Posted on21 Feb 2024
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A stability-indicating assay method is a type of analytical technique used in pharmaceutical analysis to determine the stability of a drug substance or drug product... Read More