Description
Biopharmaceutics studies are required by Part 320, Title 21, and by the Waxman-Hatch Amendments to the Federal Food, Drug and Cosmetic Act (the act).
Scope & Applicability
Stakeholders
3Entity submitting development data and knowledge; Entity performing the work process for change
Discusses humane needs and scientific requirements with the veterinarian
Specific office within the FDA center responsible for biopharmaceutics guidelines
Regulatory Context
Attributes
6Analysis by sex of clinical performance measures such as sensitivity
Ability to detect intended mechanism of action without interference; Performance characteristic to be validated
A component of precision validation; Reproducibility is assessed by means of an interlaboratory trial
Field B.2.2.2 describing the physical form of the VMP
controls in place to maintain the strength, composition, and purity
Operating parameter for the dissolution apparatus
Related CFR Sections (1)
- 21CFR10.90§ 10.90 Food and Drug Administration regulations, recommendations, and agreements.
(a) Regulations. FDA regulations are issued in the Federal Register under § 10.40 or § 10.50 and codified in the Code of Federal Regulations. Regulations may contain provisions that will be enforced as legal requirements, or which are intended only as guidance documents and recommendations, or both.Read full regulation →
See Also (8)
- Considerations for Waiver Requests for pH Adjusters in Generic Drug Products Intended for Parenteral, Ophthalmic, or Otic Use: Guidance for Industry (Status: Final)
- Final In Vivo Bioavailability-Bioequivalence Studies- Analytical (Status: Final)
- Topical Dermatologic Corticosteroids: in Vivo Bioequivalence (Status: Final)
- Bioresearch Monitoring Technical Conformance Guide (Status: Final)
- Data Integrity for In Vivo Bioavailability and Bioequivalence Studies (Status: Draft)
- Fixed-Combinations and Single-Entity Versions of Previously Approved Antiretrovirals for the Treatment or Prevention of Human Immunodeficiency Virus-One Under the President’s Emergency Plan for Acquired Immunodeficiency Syndrome Relief (Status: Draft)
- CVM GFI #171 - Demonstrating Bioequivalence for Soluble Powder Oral Dosage Form Products and Type A Medicated Articles Containing Active Pharmaceutical Ingredients Considered to Be Soluble in Aqueous Media (Status: Final)
- Statistical Approaches to Establishing Bioequivalence (Status: Draft)