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Titles
- Bioavailability studies submitted in NDAs or INDs: general considerations1
- Compliance policy for the quantity of bioavailability and bioequivalence samples retained under 21 CFR 320.38(c)1
- Extending expiration dates of doxycycline tablets and capsules in strategic stockpiles: guidance for government public health and emergency response stakeholders1
- Liposome drug products: chemistry, manufacturing, and controls : human pharmacokinetics and bioavailability : and labeling documentation1
- Regulatory classification of pharmaceutical co-crystals1
- Waiver of in vivo bioavailability and bioequivalence studies for immediate-release solid oral dosage forms based on a biopharmaceutics classification system1