What is product specific guidance?

Increased transparency on product-specific guidances gives applicants seeking to develop generic drugs a better opportunity to efficiently allocate resources. The agency aims to ensure that policies and regulations – and scientific standards – keep pace with the science of equivalence.

What is bioequivalence FDA?

Two products are considered to be bioequivalent when they are equal in the rate and extent to which the active pharmaceutical ingredient (API) becomes available at the site(s) of drug action.

What is an FDA draft guidance?

Guidances are documents prepared for FDA staff, the regulated industry, and/or the public that describe the Agency’s interpretation of, or policy on, a regulatory issue. Unlike statutes and regulations, guidances themselves cannot generally create legally binding requirements.

What is bioequivalence study?

Bioequivalence studies are special type of studies where two drugs or two sets of formulation of the same drug are compared to show that they have nearly equal bioavailability and PK/PD parameters. These studies are often done for generic drugs or when a formulation of a drug is changed during development.

What is generic drug product development?

The key steps in generic product development are usually characterization of the reference product, design of a pharmaceutically equivalent and bioequivalent product, design of a consistent manufacturing process and conduct of the pivotal bioequivalence study.

What is Cmax and AUC?

In bioequivalence studies, the maximum concentration (Cmax) is shown to reflect not only the rate but also the extent of absorption. Cmax is highly correlated with the area under the curve (AUC) contrasting blood concentration with time.

What is the difference between bioavailability and bioequivalence?

Bioavailability studies focus on determining the process and time frame by which a drug substance is released from the oral dosage form and moves to the site of action. On the other hand, bioequivalence studies focus on the performance of the drug product and usually involve comparisons of two drug products: T and R.

How do you write a guidance document?

Good guides vs bad guides: tips for writing guidelines

  1. Explain the purpose. Right up front, briefly explain:
  2. Write for your audience.
  3. Swap shoes.
  4. Break it down.
  5. Use plain English.
  6. Be direct.
  7. Establish a pattern.
  8. Add images.

What is bioavailability and bioequivalence?

Bioequivalence is determined based on the relative bioavailability of the innovator medicine versus the generic medicine. It is measured by comparing the ratio of the pharmacokinetic variables for the innovator versus the generic medicine where equality is 1.