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The Meaning of IVIVC: Exploring In-Vitro In-Vivo Correlation

Posted on04 Mar 2024

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An in-vitro in-vivo correlation is abbreviated as IVIVC. An in-vitro in-vivo correlation has been defined as “a predictive mathematical model describing the relationship between an...

difference between Corrective Action and Preventive Action

What is the difference between Correction, Corrective Action, Preventive Action?

Posted on04 Mar 2024

TagsCAPA

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A correction is any action that is taken to eliminate a nonconformity. Correction is like first-aid, its the instant action that is taken to correct the...

What is the significance of Black Box Warning?

Posted on04 Mar 2024

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A black box warning is the sternest warning by the U.S. Food and Drug Administration (FDA) that a medication can carry and still remain on...

What is meaning of Pipeline in a Molecule?

Posted on04 Mar 2024

TagsPipeline in a Molecule

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We have seen in pharma strategic management, the meaning of pipeline. Which is nothing but the number of products company is having in pipeline. It’s...

What is Corrective action and preventive action (CAPA)?

Posted on04 Mar 2024

TagsCAPA

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Corrective Action and Preventive Action (CAPA) management is the focal point of an effective quality management system. FDA, ISO, EMEA, and other regulatory bodies expect...

Key pharmaceutical business region acronym

Posted on04 Mar 2024

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Followings are the key acronym which is used in pharmaceutical global business / international trade regularly. APAC: Asia-Pacific BENELUX: Belgium, Netherlands and Luxembourg. BRIC: Brazil, Russia,...

What is Code of Federal Regulations (CFR) from pharmaceutical?

Posted on04 Mar 2024

Tags21 CFR

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The Code of Federal Regulations (CFR) is the codification of the general and permanent rules and regulations (sometimes called administrative law) published in the Federal...

Inbound and outbound marketing in pharmaceuticals

Posted on04 Mar 2024

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Inbound Marketing is the process of attracting the attention of prospects, via content creation, before they are even ready to buy; it’s one of the...

Breakthrough Fast Track Priority Accelerated Approval

Write differences between Breakthrough Therapy Designation, Fast Track Designation, Priority Review Designation and Accelerated Approval

Posted on04 Mar 2024

TagsAccelerated Approval, Breakthrough Therapy Designation, Fast Track Designation, Priority Review Designation

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There is differences between Breakthrough Therapy Designation, Fast Track Designation, Priority Review Designation and Accelerated Approval. Here is a quick comparison of the USFDA drug...

What are the application of IVIVC?

Posted on03 Mar 2024

TagsIVIVC

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In vitro-in vivo correlation (IVIVC) models are having various applications. We are hereby listed IVIVC applications: Product development of new formulations, pre-formulation studies, laboratory scale...

What is Exploratory IND studies?

Posted on03 Mar 2024

TagsExploratory IND

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IND stands for Investigational New Drugs. Exploratory IND studies usually involve very limited human exposure and have no therapeutic or diagnostic intent. These studies can...