Description
Antimicrobial drugs differ from other classes of drugs in that they are intended to affect microbial, rather than patient, physiology. For this reason, the technical reports of in vivo and in vitro effects on microorganisms are critical for establishing effectiveness.
Key Topics
Terms and concepts identified from this document
Scope & Applicability
Product Classes
1In vitro studies used to determine PD characteristics like susceptibility.
Stakeholders
2entity submitting marketing applications
individual receiving expanded access treatment; The individual receiving the investigational treatment and providing consent.
Regulatory Context
Regulatory Activities
2the studies should be completed prior to phase III studies
Trials conducted to support approval of drugs
Document Types
4Include a bibliography and copies of all published reports of studies
detailed bases for the assessment of individual subject responses
preparing the microbiology section of an application
technical section on microbiology data describing biochemical basis and antimicrobial spectrum
Attributes
2describe the stability of the drug in the presence of enzymes produced by microorganisms
determination of the drug's in vitro antimicrobial spectrum
Technical Details
Substances
1Ingested drugs that can potentially alter the ecology of the intestinal flora
Testing Methods
5Provide a detailed discussion of the development of a clinical laboratory susceptibility test method
quantitative susceptibility test results for each species, preferably obtained by diffusion testing methods
used to measure microbiologically active form
measures the microbiologically active form by either microbiological assays or chemical tests
effectiveness must be demonstrated against each indicated organism
Processes
2summarize the results of any efficacy studies in experimentally infected animals
characterization of PK profile in phase 1
Clinical Concepts
2provide a brief summary of resistance to the drug
Antimicrobial drugs are intended for use against infections in a variety of anatomic sites
Identified Hazards
Hazards
1Development of resistance in the microorganism is the greatest obstacle to the use of antimicrobials
Standards & References
Specifications
1the minimal inhibitory concentration (MIC) values when available
Related CFR Sections (2)
- 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 →
- 21CFR314.50§ 314.50 Content and format of an NDA.
NDAs and supplements to approved NDAs are required to be submitted in the form and contain the information, as appropriate for the particular submission, required under this section. Three copies of the NDA are required: An archival copy, a review copy, and a field copy. An NDA for a new chemical enRead full regulation →
See Also (8)
- Nonclinical Pharmacology/Toxicology Development of Topical Drugs Intended to Prevent the Transmission of Sexually Transmitted Diseases (STD) and/or for the Development of Drugs Intended to Act as Vaginal Contraceptives (Status: Final)
- Guidance for the Development of Vaginal Contraceptive Drugs (NDA) (Status: Final)
- Summary for New Drug and Antibiotic Applications--Format and Content of the Summary for New Drug and Antibiotic Applications (Status: Final)
- Formatting, Assembling and Submitting New Drug and Antibiotic Applications* (Status: Final)
- Format and Content of the Human Pharmacokinetics and Bioavailability Section of an Application (Status: Final)
- Nuclear Pharmacy Guideline Criteria for Determining When to Register as a Drug Establishment (Status: Final)
- ANDA Submissions – Prior Approval Supplements Under GDUFA: Guidance for Industry (Status: Final)
- CPG Sec. 400.210, Radiofrequency Identification Feasibility Studies and Pilot Programs for Drugs (Status: Final)