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1. Regulatory classification of pharmaceutical co-crystals

Publication:

Silver Spring, MD : Center for Drug Evaluation and Research, February 2018

Subject(s):

Chemistry, Pharmaceutical -- classification
Chemistry, Pharmaceutical -- standards
Crystallization -- classification
Investigational New Drug Application
Biological Availability
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

2. Liposome drug products: chemistry, manufacturing, and controls : human pharmacokinetics and bioavailability : and labeling documentation

Publication:

Silver Spring, MD : Center for Drug Evaluation and Research, April 2018

Subject(s):

Drug Compounding -- standards
Liposomes -- chemistry
Liposomes -- pharmacokinetics
Biological Availability
Chemistry, Pharmaceutical
Liposomes -- administration & dosage
Liposomes -- therapeutic use
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

3. Waiver of in vivo bioavailability and bioequivalence studies for immediate-release solid oral dosage forms based on a biopharmaceutics classification system

Publication:

Silver Spring, MD : Center for Drug Evaluation and Research, December 2017

Subject(s):

Biological Availability
Drugs, Investigational -- pharmacokinetics
Investigational New Drug Application
Therapeutic Equivalency
Administration, Oral
Biopharmaceutics -- classification
Drugs, Investigational -- administration & dosage
Excipients
Permeability
Prodrugs
Solubility
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

4. Compliance policy for the quantity of bioavailability and bioequivalence samples retained under 21 CFR 320.38(c)

Publication:

[Silver Spring, MD] : Center for Drug Evaluation and Research, August 2020

Subject(s):

Biological Availability
Therapeutic Equivalency
Biopharmaceutics
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

5. Bioavailability studies submitted in NDAs or INDs: general considerations

Publication:

Silver Spring, MD : Center for Drug Evaluation and Research, April 2022

Subject(s):

Biological Availability
Clinical Trials as Topic
Drug Approval
Drug Evaluation
Investigational New Drug Application
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

6. Extending expiration dates of doxycycline tablets and capsules in strategic stockpiles: guidance for government public health and emergency response stakeholders

Publication:

Silver Spring, MD : Center for Drug Evaluation and Research, April 2019

Subject(s):

Anthrax -- drug therapy
Civil Defense
Doxycycline -- supply & distribution
Doxycycline -- therapeutic use
Post-Exposure Prophylaxis
Strategic Stockpile
Biological Availability
Drug Stability
Drug Storage
Legislation, Drug
Biological Availability
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
United States.