Veeprho Group

Summary of ICH M9 So, according to ICH M9, a product is applicable for a biowaiver if the drug substance is either Class I or Class III. This means that a highly soluble and highly permeable drug substance (Class I), or a highly soluble but low permeability drug substance (Class III), can be granted a biowaiver. Composition must be the same or similar to the reference product, and the similarity factor when calculated for the test and reference product should be more than 50 in all media. The product should show a very fast or fast dissolution rate. Eligibility Criteria As per this guideline, the drug product is eligible for the BCS-based biowaiver if the drug substance complies with the criteria of solubility and permeability. Class I and Class III drug substances thus qualify for the biowaiver when they comply with solubility, permeability and other criteria. Class I drugs are highly soluble and highly permeable, while Class III drugs are highly soluble but have low permeability. ... Continue reading →

The growing number of product recollects in contemporary months has again enchanted us of how important the purity of drug ingredients is. The existence of unwanted chemicals, even in small amounts, may influence the efficacy and safety of pharmaceutical products. Numerous analytical techniques are applied for purity checks. Any medicine directed to or taken by a patient either a pill or capsule can be administered orally or a medicinal injection is known as a drug product. There are two main components of any drug product that are a drug substance (also known an "active pharmaceutical ingredient" or "API") and excipients. A drug substance is accountable for a medicine’s required therapeutic effect. Any other intended ingredients in a drug product are known as  Excipients or inactive ingredients or impurities. Excipients do not employ any purposeful clinical effect, but  have other essential roles in the final drug product such as being a ... Continue reading →