PHARMA BASICS: INN and USAN

Posted:September 22, 2021 | Tags: #drugdevelopment #pharmaceuticalportfolio #pharma #biotech #INN #USAN

An International Nonproprietary Name (INN) is an official generic and nonproprietary name given to a pharmaceutical drug or active ingredient. INN identifies pharmaceutical substances or active pharmaceutical ingredients. Each INN is a unique name that is globally recognized and is public property. A nonproprietary name is also known as a generic name. The INN system is managed by the World Health Organization (WHO). The INN system has been coordinated by the World Health Organization (WHO)...

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PHARMA BASICS: Drug Development Plan

Posted:September 22, 2021 | Tags: #drugdevelopment #pharmaceuticalportfolio #pharma #biotech

Drug development can be described as the process of obtaining the relevant information necessary to be included in your drug prescribing information. Development Plan (DP) is the strategic document that guides the lifecycle of a new product from the preclinical lead compound stage through Lifecycle Management (LCM). LCM starts with the first approval of BLA/NDA (first Marketing Authorization) and encompasses the development of new indications. In mature pharma organizations, DP is approved...

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Short Guide to Pharmaceutical Product Management

Posted:September 22, 2021 | Tags: #drugdevelopment #pharmaceuticalportfolio #pharma #biotech

The pharmaceutical R&D portfolio is usually formed by combining several assets. It can include discovery, preclinical and development stage small molecules and biologics (Phase I-IV) or medical devices. Less mature biotech companies usually own either a single project or platform, and there is not yet an actual R&D portfolio to manage. Large pharma or biotech organizations have real and sometimes complex portfolios with numerous projects at various stages of development. Decisions around...

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