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American Family Children's Hospital

Late Stage Preclinical Development

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Drug Manufacturing


Drug manufacturing provides specific information necessary for the IND submission such as:

  • Data which supports the purity, identity, strength and stability under various conditions (such as temperature, light and time)
  • Impurity profile consistent with the material used in nonclinical toxicology studies
  • Formulation consistent between the drug used in nonclinical studies and clinical formulation

While the intent of drug development is to provide a formulation that provides the appropriate drug delivery characteristics necessary for clinical trials, drug formulation used in Phase 1 clinical trials may simply be an oral solution or a suspension dose which may be different than the final manufactured product.




Pharmacology/Toxicology (Pharm/Tox)


The Pharm/Tox supporting sections of the IND contain an integrated summary of the information obtained from the nonclinical studies. The intent of nonclinical toxicology and pharmacology studies typically performed on large animal models is to:

  • Identify a safe starting dose or dose escalating scheme for the proposed clinical trial
  • Monitor toxic effects on organs for identification of organ toxicity that should be specifically monitored in the proposed clinical trial
  • Evaluate carcinogenicity and teratogenicity risks

Common toxicology testing may include:

  • Repeat dose toxicity
  • Absorption, distribution, metabolism, and excretion studies (ADME)
  • Genotoxicity
  • Carcinogenicity
  • Immunotoxicity
  • Reproductive toxicity

However, the exact toxicology testing required will depend on the intended clinical use.


Additionally, a very limited assessment of safety pharmacology should be performed. Core battery tests should include evaluation of vital organ function: cardiovascular, respiratory, and central nervous system.




Clinical Protocol/IND Submission


OTRS can help make connections for clinical protocol development and the IND process as well as assist with the IND application submission.


Please refer to IND section for the list of requirements necessary for the IND submission.

In addition to IND application items, the following details for the clinical protocol are extremely important in the submission:

  • Starting dose
  • Dose escalation
  • Inclusion/exclusion criteria for the population to be studied
  • Definition of dose-limiting toxicity
  • Monitoring of adverse effects