IND Enabling Studies FDA

Medicilon provide the IND filing for the preclinical services. Medicilon could submit the application for both US FDA and CFDA for your new drug. Medicilon is the first CRO to offer preclinical animal testing service for the global pharmaceutical companies in China. Medicilon is the CRO that fulfill both the Chinese and US GLP standards. Since 2004, we have successfully helped our clients to submit their new drug application to US FDA and CFDA and met the requirements of the US FDA and CFDA. We have undergone several inspections and passed all of them.  Medicilon will provide an efficient, cost-effective and professional service to help our clients to achieve their goals.

IND Preclinical Studies

IND-enabling studies are conducted to evaluate potential toxicity risks prior to human studies and to estimate starting doses for clinical trials. An IND (Investigational New Drug) is required to conduct a clinical trial of an unapproved drug or an approved product for a new indication or in a new patient population new indication or in a new patient population.

IND-enabling pharmacology, DMPK & toxicology studies

Need to align with clinical route of administration, dose schedules, & duration of treatment. Design to identify: PK/PD responses, target organs, dose response, exposure multiples & safety margins.

IND-Enabling (Pivotal) GLP

•  Typically 14-28 day repeat dose to support SAD & MAD Ph I clinical studies;

• Intended as survey studies. Expected to include endpoints relevant to molecular class,anticipated toxicity,PD identification;

• Dose selection intended to elicit toxicity;

• Primary endpoints are clinical pathology & anatomical pathology assessments with TK profile correlates;

• Goals: Identify target organ toxicity/pathology, translational predictive safety biomarkers, assess reversibility or progression, assess local tolerance, determine adverse effects with NOAEL & exposure ratios;

• Basis for selecting initial clinical doses & escalation.

IND-Enabling Toxicology

Specific Assessments as Indicated

• Local effects (ex. injection or application site);

• Specific safety biomarkers as appropriate(clinical pathology or specialty assay);

• Immunogenicity as warranted (anti-drug antibody);

• Immune suppression or cytokine storm.

Common Concerns / Issues

• Blood volume limitations for large animals;

• TA consumption substantial;

• TA preferred same batch as Ph I;

• Maintain purity of purpose = IND enabling. Avoid discovery investigations; pitfall for including unneeded endpoints.

Development Timelines and Resources

Chemical Development (6-8 months)

– Synthetic process improvement & production of gram batches;
– Chemical synthesis process development for 1-10 Kg batch;
– API characterization and stability established;
– Initial non-clinical & clinical formulations developed;
– Drug product characterization supporting early clinical use.

Drug Safety and Metabolism (8-10 months)

– In vitro DMPK studies;
– Pilot pharmacokinetic & toxicology studies;
– Drug safety IND-enabling toxicity studies(14-28day rodent and non-rodent);
– Genotoxicity assays;
– Safety pharmacology profile.

Program Outcome

– IND filed 10 – 12 months after lead selection, barring any technical or safety issues. Requires parallel activities including IND preparation and clinical plan determination (15-18 months for biologics);
– Commercially-viable prototype API process developed and demonstrated.

Contact Us 

Email : marketing@medicilon.com
Tel : +86 021 58591500

Tips:  Above is part of IND Enabling Studies FDA and FDA IND Service. You can also CONTACT US with any question or enquiry you may have. We will be happy to discuss your needs in detail and design an appropriate plan of action.

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