Drug products defined

Bioavailahility is defined as the rate and extent to which the active ingredient or active moiety is absorbed from a drug product and becomes available at the site of action. 

The authorisation of generic medicinal products is covered by Article 10 of the Human Medicines Directive 2001/83/EC and Article 13 of the Veterinary Medicines Directive 2001/82/EC. A generic drug is defined as a medicinal product that has ... 

The final option is the Centralized Procedure. This is available for a defined list of product types (included in an Annex to the relevant Regulation) and for Orphan Drugs as defined by the Orphan Drug Committee. This procedure involves the appointment of... 

What defines a dietary supplement versus a drug As defined by Congress in the Dietary Supplement Health and Education Act (which became law in 1994), a dietary supplement is a product (other than tobacco) that ... 

Table 1. Pre-defined Analytical Method Transfer Acceptance Criteria for API and Drug Product (adapted from Agut et al., 2011)...

In this example, of transfer of a drug product dissolution method, the samples are independent (as test is destructive in nature) and additional variability due to different baths/standard sets are assumed to be negligible (dissolution baths were independently calibrated as per USP criteria). Based on the receiving site s familiarity with the methodology to be transferred, only one analyst/dissolution bath per site was used. The analyses were performed at USP level 2, i.e. 12 individual samples were tested. The standard deviation on 12 replicate analyses from an earlier study was 3.02 (Borman et al., 2009). The authors indicated that as this estimate is based on a limited number of replicates, it was good practice to use a pre-defined multiplier, which allows for uncertainty (Hahn and Meeker, 1991), in this case 1.255 (multiplier for... 

The FDA s dehnition of comparability protocol is a well-defined, written plan for assessing the effect of specific CMC changes in the identity, strength, purity, and potency of a specific drug product as these factors relate to the safety and effectiveness of the product. A comparability protocol describes changes that are covered under the protocol and specifies the tests and studies that will be performed, including analytical procedures that will be used, and acceptance criteria that will be achieved to demonstrate that specified CMC changes do not adversely affect the product. ... 

A stability-indicating method is a validated quantitative analytical procedure that can detect the changes with time in the pertinent properties of the drug substance and drug product under defined storage condition. A stability-indicating assay method accurately measures the active ingredient(s) without interference from other peaks and is sensitive... 

Drug substance and drug product undergo enormous testing efforts before they can be administered to patients. The specifications to ensure the product quality are defined in the early development phase and will be monitored through the whole life cycle. 

It is widely understood within the industry that risk is defined as the combination of the probability of harm and the severity of that harm. Within the pharmaceutical industry whenever risk is considered the equipment or product being assessed must be viewed in the context of the protection of the patient. From our perspective, analytical instruments may impact on the validity of data that determines the safety and efficacy of drug products, or on the quality of the drug product. They may also impact on the identity or potency of the drug product and therefore it is important to ensure that risk management is performed throughout the complete life cycle of the instrument. 

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