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SAFETY FIRST: Assessing Drugs Early Can Preclude Regulatory and Health Issues

A Guide to When & Why to Evaluate ADME/PK & Drug-Drug Interactions

With a thorough and well-executed development plan and proper risk assessment, pharmaceutical manufacturers can be confident about the safety of their drugs—and so can the patients who need those medicines. Failure to plan and execute a thorough preclinical program can lead to consequences that stop a drug from advancing to the clinic. One must explore each new drug candidate’s victim and perpetrator potential in order to successfully meet regulators’ expectations of drug safety testing, but sponsors planning DDI and ADME preclinical work need to be aware that there is no one-size-fits-all model for program design. 89.5% of drug candidates in preclinical development drop out along the way or fail to meet requirements for entry to clinical trials. This 26 page ebook outlines:

  • A safe drug starts with a solid plan
  • Pharmacokinetics expose drug-drug interaction potential
  • Preclinical studies identify risk of drug-drug interactions
  • A more complete picture of drug activity


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