What are comparability protocols?

What are comparability protocols?

According to FDA, a CP “is a comprehensive, prospectively written plan for assessing the effect of a proposed CMC postapproval change(s) on the identity, strength, quality, purity, and potency of a drug product or a biological product (i.e., product), as these factors may relate to the safety or effectiveness of the …

What is a comparability study?

Comparability Bridging Study: A study performed to provide nonclinical or clinical data that allows extrapolation of the existing data from the drug product produced by the current process to the drug product from the changed process. In some cases, nonclinical or clinical data might contribute to the conclusion.

What is comparability protocol FDA?

A Comparability Protocol (CP) is a highly specific, well-defined plan for the future implementation of a Chemistry, Manufacturing and Controls (CMC) change.

What is PK comparability?

A PK/PD focused comparability approach has been widely taken to support process changes prior to the conduct of large clinical efficacy and safety trials. Compared to data from a single dose PK/PD study, ADA data from a repeat-dose efficacy and safety trial would be more relevant for comparability assessment.

What is the difference between Biosimilarity and comparability studies?

The manufacture of biologics is a complex process involving numerous steps. A comparability assessment is distinct from a biosimilarity assessment, which involves extensive assessment of a biologic that is highly similar to the originator (reference product) in terms of quality, safety, and efficacy.

What is tox material?

Toxic materials are substances that may cause harm to an individual if it enters the body. Toxic materials may enter the body in different ways. These ways are called the route of exposure. The most common route of exposure is through inhalation (breathing it into the lungs).

What is a clinical bridging study?

A bridging study is defined as a supplemental study performed in the new region to provide pharmacodynamic or clinical data on efficacy, safety, dosage and dose regimen in the new region that will allow extrapolation of the foreign clinical data to the new region.

What is a registration batch in pharma?

Registration Batches means that batch or batches of Atamestane drug substance and/or drug product made under GMP conditions that is or are necessary to support the filing of a marketing application or a new drug application for Licensed Product.

What is a Japanese bridging study?

Bridging studies are clinical trials to compare the safety and effects of IMPs in different ethnic groups. Bridging studies can help sponsors get earlier approval for their IMPs in Japan. Since 1993, we’ve done many studies in healthy Caucasians for Japanese companies, large and small.

What is ICH E5?

The ICH-E5 guideline provides a general framework for evaluating the potential impact of ethnic factors on the acceptability of foreign clinical data, with the underlying objective of minimizing duplication of clinical data, and it also describes the requirement of bridging studies for extrapolation of foreign clinical …

Which is the best definition of a comparability protocol?

• A comparability protocol is a comprehensive, prospectively written plan for assessing the effect of a proposed CMC post-approval change(s) on the identity, strength, quality, purity and potency of a drug product or a biological product (i.e., product), as these factors may relate to the safety or effectiveness of the product (i.e., product

Which is the best definition of comparability assessment?

Assessment Concepts in Comparability Assessment (ICH Q5E) A determination that a product is “Comparable” indicates that products before and after a manufacturing change are highly similar and that no adverse impact on the quality, safety or efficacy of the drug product has occurred

What is the goal of the comparability exercise?

The goal of the comparability exercise is to ensure the quality, safety and efficacy of drug product produced by a changed manufacturing process, through collection and evaluation of the relevant data to determine whether there might be any adverse impact on the drug product due to the manufacturing process changes.

When to include nonclinical studies in comparability studies?

• However, where the relationship between specific quality attributes and safety and efficacy has not been established, and differences between quality attributes of the pre – and post-change product are observed, it might be appropriate to include a combination of quality, nonclinical, and/or clinical studies in the comparability exercise Pg#