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What is meaning of Common Technical Document (CTD)?

Posted on04 Dec 2023

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The Common Technical Document (CTD) is a set of specification for application dossier for the registration of Medicines. And it is designed to be used across Europe, Japan and the United States. It was developed by the European Medicines Agency (EMA,Europe), the Food and Drug Administration (FDA, U.S.) and the...

What is the meaning and significance of ‘First to File’ Generics?

Posted on04 Dec 2023

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The first to file generics submits a substantially completed Abbreviated New Drug Application to receive marketing exclusivity for 180 days. Let us understand the concept better. A generic drug is a pharmaceutical drug that is equivalent to a brand-name product in dosage, strength, route of administration, quality, performance and intended use. In most cases, generic products...

What is a CDMO?

Posted on04 Dec 2023

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A Contract Development and Manufacturing Organization (CDMO) serves clients various services from drug development to contract manufacturing. Services offered by CMOs include, but are not limited to: pre-formulation, formulation development, stability studies, method development, pre-clinical and Phase I clinical trial materials, late-stage clinical trial materials, formal stability, scale-up, registration batches and...

How much is the average ideal royalty rate in pharmaceutical and biopharmaceutical business deal?

Posted on04 Dec 2023

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What is the difference between Market withdrawal and Product Recall?

Posted on04 Dec 2023

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Product Recalls are actions taken by a firm to remove a product from the market. by FDA request, or by FDA order, whereas Market withdrawal occurs when a product has a minor violation that would not be subject to FDA legal action. Product Recalls are actions taken by a firm...

What is difference between phase IIa and Phase IIb clinical trial?

Posted on04 Dec 2023

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Phase II studies are sometimes divided into Phase IIA and Phase IIB. Phase IIA is specifically designed to assess dosing requirements (how much drug should be given). Objectives may focus on dose-response, type of patient, frequency of dosing. Phase IIB is specifically designed to study efficacy, how well the drug...

What is PIC/S? Is India part of PIC/S?

Posted on04 Dec 2023

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The Pharmaceutical Inspection Co-operation Scheme (PIC/S) is a non-binding, informal co-operative arrangement between Regulatory Authorities in the field of Good Manufacturing Practice (GMP) of medicinal products for human or veterinary use. Pharmaceutical Inspection Co-operation Scheme (PIC/S) is the international instruments between countries and pharmaceutical inspection authorities, i.e regulatory bodies. The...

What is the difference between purity and potency?

Posted on04 Dec 2023

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Purity means relative freedom from extraneous matter in the finished product, whether or not harmful to the recipient or deleterious to the product. Purity includes but is not limited to relative freedom from residual moisture or other volatile substances and pyrogenic substances. The word potency is interpreted to mean the...

What are DACH region? Which countries are part of DACH region?

Posted on04 Dec 2023

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The DACH region is part of Europen. DACH region comprises of Austria, Germany, and Switzerland. DACH countires are basically German Speaking Countries. DACH is an acronym for D — Deutschland (Germany) A — Austria CH — Confœderatio Helvetica (Switzerland)

What is difference between New Drug Application and Marketing Authorization Application?

Posted on04 Dec 2023

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Process of reviewing and assessing the dossier to support a medicinal product in view of its marketing (also called licensing, registration, approval, etc.), obviously finalized by granting of a document also called marketing authorization (equivalent: product license). This process is performed within a legislative framework which defines the requirements necessary...