See comments below.
Regards,
Brian Matthews.
Quoting Prasoon Mishra <pkmishra@promedgroup.com>:
> We have set up a new formulation unit for sterile small volume liquid
> products, using Blow-Fill-Seal technology. We are now planning to
> enter the regulated pharmaceutical markets of US, Europe, Brazil.
>
> We are developing ophthalmic Suspension/ emulsion formulation
> (Generic Product) for regulated market like ANDA, first to file. Our
> products are under development phase.
>
> We need to evaluate the feasibility of projects in terms of clinical
> trial activity (Phase III).
>
> For your information, drug is indicated for open angle glaucoma.
>
> You are kindly requested to suggest probable information about
> following queries:
>
> 1) Is it required for organization (CRO) to be approved by
> regulatory bodies viz US FDA, MHRA, and ANVISA for conducting
> clinical trial?
AS FAR AS I AM AWARE CROS ARE NOT 'APPROVED' PER SE.
> 2) How many number & type of patient would be required for
> conducting clinical trial (phase III) on ophthalmic molecule?
THIS HAS TO BE DETERMINED FROM THE POWER OF THE STUDY. BIOSTATS
INPUT WILL BE REQUIRED FOR EACH PRODUCT.
> 3) How & who will approve study protocol?
IN MOST CASES THE PROTOCOLS NEED TO BE INCLUDED IN A CLINICAL TRIAL
APPLICATION / INVESTIGATIONAL NEW DRUG
APPLICATION WHICH WILL BE SUBMITTED TO THE RELEVANT COMPETENT AUTHORITIES.
> 4) Does the clinical trial conducted in India will be
> acceptable in above said countries?
THIS WILL NEED TO BE DISCUSSED IN THE MARKETING AUTHORISATION
APPLICATION / NEW DRUG APPLICATION / ABBREVIATED NEW
DRUG APPLICATION. IT IS LIKELY TO DEPEND ON THE RELEVANCE OF THE
PATIENT POPULATION INCLUDED IN THE TRIAL TO THE
POPULATION OF THE TARGET COUNTRY.
>
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