Bioequivalence and Bioavailability Forum • regulatory requirement for Injection products

balakotu
★

India,
2014-03-18 08:34
(4484 d 02:59 ago)

Posting: # 12643
Views: 3,095

regulatory requirement for Injection products [Regulatives / Guidelines]

Dear All,

Please clarify the below query

We are planning to submit a ANDA for USA submission for an injectable solution product meant for subcutaneous route of administration.

The product is a sterile, colorless clear isotonic solution in a glass cartridge which is preassembled into a disposable deliver device (pen).

Please suggest on whether biostudy is required or we can proceed based on biowaiver for such type of products.

Regards
Kotu

luvblooms
★★

India,
2014-03-19 06:24
(4483 d 05:09 ago)

@ balakotu
Posting: # 12662
Views: 2,514

regulatory requirement for Injection products

Post reply

Dear Kotu

First look for the available recomendations at this link.

If information not available, look for the related compounds of similar category for Eg. Enoxaparin Sodium and Dalteparin Sodium.

IF still unable to get the information, initiate the control correspondence with FDA.

(If I am getting it right, your drug is either a low molecular weight heparin, in that condition you need to do detailed Q1/Q2 analysis and have to meet following five criteria for demonstrating active ingredient sameness of the test and reference products are:

Equivalence of physicochemical properties
Equivalence of heparin source material and mode of depolymerization
Equivalence in disaccharide building blocks, fragment mapping, and sequence of oligosaccharide species
Equivalence in biological and biochemical assays
Equivalence of in vivo pharmacodynamic (PD) profile)

I may be wrong but!!!

Regards

—
~A happy Soul~