Description
This guidance provides recommendations to sponsors of new drug applications (NDA's), abbreviated new drug applications (ANDA's), and abbreviated antibiotic applications (AADA's) who intend, during the postapproval period, to change: 1) the components or composition; 2) the site of manufacture; 3) the scale-up/scale-down of manufacture; and/or 4) the manufacturing (process and equipment) of an immediate release oral formulation.
Scope & Applicability
Product Classes
3Applicable to tablets, capsules, and granules/powders for oral suspension.
General category for tablets and capsules discussed in the coating and drilling sections.
Scope of the bioequivalence guidance; Scope of the guidance document; Scope of the M13B guideline; Scope of the ICH M13B guideline
Stakeholders
2Employees handling RTE foods or cleaning equipment
The number of subjects provided in the table (N)
Regulatory Context
Attributes
9characteristic of a drug that increases risk of adverse effects if clearance is impaired
area under the concentration-time curve used to assess BE
Cmax may be more informative for safety
An f2 value between 50 and 100 suggests the two dissolution profiles are similar.
Reported in annual report for production batches
Three months of data required for Level 3 changes; Three months of data typically required for Level 2 and Level 3 changes.; Changes Being Effected supplement (all information including accelerated stability data)
manufacture representative of full manufacturing scale, minimum one tenth or 100,000 units
BCS classification parameter, potentially time-dependent
Defined as extent of absorption greater than 90%
Related CFR Sections (6)
- 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 →
- 21CFR320.1§ 320.1 Definitions.
The definitions contained in § 314.3 of this chapter apply to those terms when used in this part.Read full regulation →
- 21CFR314.70§ 314.70 Supplements and other changes to an approved NDA.
(a) Changes to an approved NDA.Read full regulation →
- 21CFR210.3§ 210.3 Definitions.
(a) The definitions and interpretations contained in section 201 of the act shall be applicable to such terms when used in this part and in parts 211 , 225 , and 226 of this chapter .Read full regulation →
- 21CFR314.3§ 314.3 Definitions.
(a) The definitions and interpretations contained in section 201 of the Federal Food, Drug, and Cosmetic Act apply to those terms when used in this part and part 320 of this chapter .Read full regulation →
- 21CFR310.3§ 310.3 Definitions and interpretations.
As used in this part:Read full regulation →
See Also (8)
- Topical Dermatologic Corticosteroids: in Vivo Bioequivalence (Status: Final)
- Metaproterenol Sulfate and Albuterol Metered Dose Inhalers In Vitro (Status: Final)
- CVM GFI #57 Preparation and Submission of Veterinary Master Files (Status: Final)
- Guidance for Industry for the Submission of Chemistry, Manufacturing, and Controls Information for a Therapeutic Recombinant DNA-Derived Product or a Monoclonal Antibody Product for In Vivo Use (Status: Final)
- Guía para la Industria: Formas de dosificación oral de liberación prolongada: elaboración, evaluación y aplicación de correlaciones in vitro/in vivo (Status: Final)
- Extended Release Oral Dosage Forms: Development, Evaluation, and Application of In Vitro/In Vivo Correlations (Status: Final)
- ANDAs:Pharmaceutical Solid Polymorphism: Chemistry, Manufacturing, and Controls Information: Guidance for Industry (Status: Final)
- Bioavailability and Bioequivalence Studies Submitted in NDAs or INDs — General Considerations (Status: Draft)