Blog - Royed Training

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...

What are the key factors which affect royalty rate in pharmaceutical industry?

Posted on29 Feb 2024

TagsRoyalty Rate

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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...

How much is the ideal royalty payment in pharmaceutical industry?

Posted on29 Feb 2024

TagsRoyalty Rate

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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...

What is the meaning of Masking or Blinding?

Posted on24 Feb 2024

TagsBlinding, MASKING

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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...

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...

12 Skills what Product Manager should have!

Posted on22 Feb 2024

TagsProduct Manager

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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...

What is the meaning of PIVOTAL TRIAL?

Posted on22 Feb 2024

Tagspivotal trial

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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....

What is difference between CAPEX and OPEX in business?

Posted on22 Feb 2024

TagsCAPEX, OPEX

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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...

Case Study: Product Recall due to labeling error

Posted on21 Feb 2024

Tagsproduct recall

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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...

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...

What are the difference between Wholesaler and Specialty Pharmacy?

Posted on21 Feb 2024

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There are clear cut difference between the two terms. The wholesalers are the first purchaser of the drug, directly from manufacturer. Specialty pharmacy involves in...

Case Study: Backward integration in Pharmaceutical Business

Posted on21 Feb 2024

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Backward integration refers to the process in which a company purchases or internally produces segments of its supply chain. In other words, it is the...