Issue link: https://resources.nanotempertech.com/i/1267034
Target discovery & validation - Hit screening, lead validation, and optimization Animal Pharmacology and Toxicology Studies - Preclinical data to permit an assessment as to whether the product is reasonably safe for initial testing in humans FDA: Center of Drug Evaluation and Research (CDER) evaluates the IND and allows clinical trials to proceed, or issues a "clinical hold" if more information is needed Clinical Trials - Phase 1 - Phase 2 - Phase 3 FDA: CDER reviews NDA to provide doctors and patients with the information they need to use medicines wisely Approved or Not Approved Post-marketing safety monitoring Patent expires 20 years a er approval For every 5,000-10,000 compounds that enter the research and development (R&D) pipeline, ultimately only one receives approval 8 Nearly 14% of all drugs in clinical trials eventually win approval from the FDA 9 Only 30% or less of initial drug candidates make it to approved NDA status The cost per single therapeutic developed and approved can range from $19 million to $5 billion 10 General stability requirements for IND l Information sufficient to support stability of the drug substance during the toxicological studies and the planned clinical studies General stability requirements for NDA l Minimum of 12 month (long-term) and 6-month (accelerated) for three primary batches l Any available supporting stability data l Appropriate statistical analysis, if needed l Stability data on reconstitution/ dilution/admixing at initial and final time points l Data from forced degradation and photostability studies l Appropriate post approval stability commitments IND Investigational New Drug Application NDA New Drug Application Year 1 Year 2 Year 4 Year 8-9 Year 10-11 Year ~30 High throughput, low volume requirement (e.g., nanoDSF, DSF, CD, SEC) Full complement of stability assays: (e.g., nanoDSF, DSF, CD, SEC Full complement of stability assays Full complement of stability assays Stability studies at the Investigational New Drug (IND) stage provide impurity profiles for investigational products used during non-clinical toxicological studies. These tests ensure that the quality and safety of the investigational drug is acceptable throughout the clinical trial period. At the New Drug Application (NDA) stage, stability studies establish appropriate retest or expiration guidelines, long-term storage conditions, and provide evidence of the effect of various environmental conditions on the quality of the drug substance (active ingredient) and drug product (finished dosage form). Journey of a mAb through IND and NDA filing 3