Bioequivalence and Bioavailability Forum • change of name in investigational products

vivekanand
☆

India,
2012-11-24 15:40
(4964 d 12:09 ago)

Posting: # 9580
Views: 4,467

change of name in investigational products [Regulatives / Guidelines]

Dear All

In a BA/BE study a protocol designed with two way crossover where the reference product name mentioned as XXXXX manufactured by XYZ.

In general IPs need to be received to CRO as per the details of protocol along with the regulatory approval (T-License) for the study (if applicable).

If Reference IPs received are not matching with details mentioned in protocol and regulatory approval 'like Name and manufactured by' can we conduct the study by generating an amendment to the protocol.

If not please mention in detail.

Regards
G.Balavivekanand

drgunasakaran1
★★

2012-11-24 16:06
(4964 d 11:42 ago)

@ vivekanand
Posting: # 9582
Views: 3,750

change of name in investigational products

Post reply

Dear Mr Balavivekanand,

If there is change only in the Trade Name of the Reference product and manufacturer details, you can raise protocol amendment for the same. You need to get Ethics committee approval for your amendments and send an Intimation letter to the Regulatory body along with your Ethics Committee approved protocol amendment before initiating the study.

Kindly be informed that if there is a change in the dosage form, strength of the reference product, frequency of administration etc., we need to get approval from both the Ethics Committee and Regulatory body before conducting the study.

—
Dr Gunasakaran Sambandan MD
Disclaimer: The replies/posts are my personal opinions, and they do not represent my company's views on the same. LinkedIn

Dr RCG
☆

2012-11-24 17:01
(4964 d 10:48 ago)

@ vivekanand
Posting: # 9586
Views: 3,741

change of name in investigational products

Post reply

❝ In a BA/BE study a protocol designed with two way crossover where the reference product name mentioned as XXXXX manufactured by XYZ. In general IPs need to be received to CRO as per the details of protocol along with the regulatory approval (T-License) for the study (if applicable). If Reference IPs received are not matching with details mentioned in protocol and regulatory approval 'like Name and manufactured by' can we conduct the study by generating an amendment to the protocol.

I my experience, reference product details is a part of study design. If any study design is changed inculding reference product details (not matching with protocol), you need to take approval for the change (version number of the protocol will be changed and submitted to DCGI for approval with ethics committee approval letter).

Present scenario of DCGI is not known :confused:

, so i am in doubt that DCGI will agree with only amendment made. Thanks.

Regards; RCG

drgunasakaran1
★★

2012-11-24 18:36
(4964 d 09:13 ago)

@ Dr RCG
Posting: # 9587
Views: 3,755

change of name in investigational products

Post reply

Dear Dr RCG,

❝ reference product details is a part of study design. If any study design is changed inculding reference product details (not matching with protocol),

As per the DCGI's Meeting conducted at IDMA office mumbai, DCGI states that those amendments which require prior permission before implementation of the amendments are

Change of Principal Investigator
Additional Patients to be recruited
Major changes in protocol with respect to study design, dose and treatment options

Source: Minutes of meeting on matters related to Global Clinical Trials,

CDSCO requires prior permission from DGCI before implementation of the protocol amendments only if there are major changes with respect to study design.
Only change in the Trade name and manufacturer details of the Reference product will not be considered as Major change and hence only intimation to DCGI is sufficient.
If the other reference product details changes such as dosage, formulation, frequency of administration, then they will be considered as Major change and we need to get approval from DCGI for the new version of protocol before conducting the study.

—
Dr Gunasakaran Sambandan MD
Disclaimer: The replies/posts are my personal opinions, and they do not represent my company's views on the same. LinkedIn

Helmut
★★★

Vienna, Austria,
2012-11-24 19:15
(4964 d 08:34 ago)

@ drgunasakaran1
Posting: # 9588
Views: 3,688

Bad idea, IMHO

Post reply

Dear Dr. Gunasakaran!

❝ As per the DCGI's Meeting conducted at IDMA office mumbai, DCGI states that those amendments which require prior permission before implementation of the amendments are […]

❝ Source: Minutes of meeting on matters related to Global Clinical Trials,

Sounds strange to me. Let’s play the devil’s advocate: The innovator markets the “same” (pun intended!) product in two countries under the same name, although the original authorization was based on “Variant A”. The product is manufactured at two different sites. “Variant B” differs for “A” in excipients, but the innovator has shown^* BE of “B” to “A”. The approved protocol is based on “A”, but we want to switch to “B” now (or worse: following Balavivekanand’s post we planned for “A” and the sponsor surprises us with “B”). What if one of the excipients in “B” (not contained in “A”) might cause allergic reactions (e.g., lactose)? Nothing is stated in the approved ICF and we might put subjects at risk.

According to the OP the products are manufactured at two different sites. That’s a major variation and would require an in vivo study anyway (even if the composition is the same; f₂ is sufficient here).

—
Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz

The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes

drgunasakaran1
★★

2012-11-27 15:25
(4961 d 12:23 ago)

@ Helmut
Posting: # 9605
Views: 3,224

Bad idea, IMHO

Post reply

❝ What if one of the excipients in “B” (not contained in “A”) might cause allergic reactions (e.g., lactose)? Nothing is stated in the approved ICF and we might put subjects at risk.

Dear Sir,
I fully agree.
If we are amending the protocol for a the new brand of reference product and if there are any changes in excipients which may cause allergic reactions (eg lactose) as you clearly stated, the same expected allergic reactions due to lactose in the new brand of reference product will be captured in the Amended-ICF and the same will be submitted to the Ethics Committee before initiating the study.

Amendment will also be raised for the Informed Consent Document (if there is a change in the reference product details) and whenever Amendment raised for Clinical Study Protocol.

—
Dr Gunasakaran Sambandan MD
Disclaimer: The replies/posts are my personal opinions, and they do not represent my company's views on the same. LinkedIn