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Dear Sir/Ma’am,
The bioequivalence study is required for Creams and injections?
Thanks & Regards
Pravin P. Deotarse
Clinical, Integrated Product Development
Cipla Limited,
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Hi
You're asking about topical against iv?
Dr. Raj K. Singh Badhan
Lecturer in Pharmacokinetics
School of Pharmacy
Aston University
Birmingham
B4 7ET
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Dear Pravin,
If the injection is a solution, bioequivalence is not required. If the injection is a suspension,
bioequivalence is required.
If the cream has systemic absorption, bioequivalence should be applied. If the cream has not
systemic absortion, bioequivalence is not applied!
Regards
Enviado por Maurício Sampaio
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Dear Pravin,
Its not quite as simple as Maurice states- the following is the position in EU
Injection- if it is an iv solution normally no study is required. However if there is an excipient
that may interfere with absorption of the active drug or otherwise affect its disposition, a study
would be required, unless you can show the reference contains the same excipient in a very similar
amount. Emulsions may need a study. Other types of injection might also need a study,
Creams- if the active drug is not systemically absorbed, in principle you need a clinical study. You
might be able to avoid this with alternative evidence of similarity in safety and efficacy and some
convincing arguments.
The guidelines are freely available on the internet- I suggest in future you refer to the guidelines
to get a quicker answer.
Regards
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