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Risk Based Monitoring (Part-2)

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It’s been a while since we last discussed monitoring of bioequivalence studies. Thank you to everyone who enjoyed those blogs and have sought more information on the same.

In this series we take a look at how has this process evolved over the last couple of years, the practical nuances and regulatory observations.

The EMA regulators in the Inspection reports to the CRO, insert observations which fall under sponsor responsibility and they state so. Monitoring is one of them. Following have been some of the recent and most pertinent observations that sponsors have received and almost all of them have been categorised as major or critical.

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Bio-INDs

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We are starting a new topic in this series of blogs, and one that sometimes results in delay in execution of the BA/BE studies for either want of preparedness or planning. Yes, you got it right, we are picking up Bio-INDs for deliberation.

Bio-INDs are investigational new drug applications (INDs) submitted for bioavailability (BA) or bioequivalence (BE) studies under 21 CFR 320.31. The Bio-IND is required by regulations in specific instances to ensure that proposed drug products that contain no-new chemical entities are safe for use in human test subjects and do not expose them to undue risk.

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CT Rules India And Bioequivalence Studies (Part-2)

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Hello and greetings from all of us at Pharmadesk!!

We hope you have had a great start to the year and wish you continued success and look forward to partnering in your initiatives in conduct of efficient and regulatory compliant studies in India. We continue our series on the requirements mandated by the new CT Rules 2019, that include bioequivalence studies in its scope. The rules themselves are available both in Hindi and English as mandated by Government of India.

The overall broad construct of the document is as follows –

After the preliminary introduction of the basis of the rules and their scope, the document is further organised into 13 chapters which contain 107 rules, each of them serially numbered from the first chapter. The chapters range from the description of the licensing authority, definitions to ethic committee requirements, BA/BE Centre requirement and requirements for study conduct. The chapter also include rules on manufacture, sale, import of drugs for CT, compassionate use, labelling etc. Several miscellaneous topics are included in the last chapter titled ‘Miscellaneous’.

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CT Rules India And Bioequivalence Studies

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We are delighted to start the new year with continuation of our blogs and also take this opportunity to thank you for being with us in 2019 and hope you enjoyed the blogs last year and found them useful. 

In the next few sessions, we take the much enquired topic on the BA/BE requirements as per the new CT Rules of 2019 laid out by the CDSCO earlier this year. The focus of the discussions here is either things that one must be aware of to ensure day to day functioning or aspects that are controversial or unclear. Please note that the text in italics is quoted directly from the CT Rules.

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Critical Updates From ICH Meetings

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While we have been discussing critical attributes and QTLs in our recent offering, of what recent ICH updates after Singapore assembly meeting are indeed well timed. Several of these guideline updates will affect sponsors who are developing generic products and we are summarising them here.

During the recent meeting, the ICH Assembly adopted several guidelines for Step 4 of the ICH process, while several working groups advanced early stage efforts toward the development of new topics and upcoming revisions to existing guidelines.

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Quality Tolerance Limits (QTL)

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We hope you found the last blog on choosing a partner CRO practically useful and implementable.

We continue the series with an important aspect that a sponsor needs to ascertain about the CRO quality systems that may affect their studies or their approval ability when submitted and that is of setting Quality Tolerance Limits or QTL.

Since the new ICH E6 guidelines have been implemented, sponsors expect the CROs to adopt a risk based approach to their QMS and their studies.

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Qualifying the Right Partner for Your Bio-Studies.

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In the last session we discussed some of the critical aspects to reduce /control the risks if any to your bioequivalence studies.

Amongst the most important of these was to choose the right partner to work with. This time let’s look at some of the vital aspects which are not directly related to the QMS, but should be assessed and addressed at the time of qualification.

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Conduction Of Biostudies without Risk

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Bioequivalence studies done as part of ANDA submissions form a crucial basis of obtaining a marketing approval.

Considering that most studies run on well-known designs, analysed by validated methods at CROs who are experienced in these studies, ideally there is little that should go wrong. It indeed is the case, that most studies are done well. However, if a dossier is refused, or receives regulatory queries as part of a complete response letter, or the study is rejected for reasons of non-compliance to applicable regulations or GCP, it not only results in an opportunity cost due to the resulting delays and also may involve forfeiture of part or whole of the GDUFA fee (for USFDA).

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Critical Factors to A Sponsor CRO Partnership and Study Success

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Sponsors are conducting BA/BE studies often have multiple studies running at the same time, often at several CROs at the same time. Each CRO have their own set of systems and way of doing things and therefore study conduct and related documentation vary from CRO to CRO.

How does one harmonise these requirements to ensure that the studies are conducted as per protocol and the dossier does not invite avoidable queries?

There are certain aspects of the study that are critical and the sponsor must pay enough attention towards the documentation, execution and oversight of these.

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