mindyhausler
8 posts
Jun 19, 2025
7:13 PM
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Drug consistency evaluation includes in-vitro pharmaceutical consistency and in-vivo bioequivalence between generic drugs and RLD, which aims to ensure that generic drugs have the same safety and efficacy as RLD. Pharmacokinetics is the most commonly used method to evaluate bioequivalence evaluation (BE). However, pharmacokinetic methods are not recommended for evaluation when the following conditions occur.
There is no correlation between plasma drug concentration and clinical efficacy.
The concentration of drugs or metabolites in plasma or urine is too low or even negligible.
The concentration of target drugs or metabolites cannot be accurately measured by existing analytical methods.
The measured drug concentration cannot accurately evaluate drugs' effectiveness and safety.
The above conditions can be studied for bioequivalence using validated pharmacodynamic methods. Pharmacodynamic methods describe the relationship between the concentration of a drug at the site of action in an organism and its pharmacological effects or adverse effects.
Alfa Chemistry provides a full range of one-stop bioequivalence (including pre-BE and formal BE) solutions for generic drug manufacturers, with a large number of BE success cases. We support manufacturers' use of clear, quantifiable, and objective pharmacodynamic studies of generic drugs comparing generic drugs with RLD to assess bioequivalence when no feasible pharmacokinetic study method is available.
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