DRUG DEVELOPMENT

FDA approval of your Investigational New Drug (IND) application is the result of a successful drug development program, which begins with STILLMEADOW, Inc.  Our AAALAC Accredited Lab with over 75,000 sq ft of lab space and a  trained staff can complete your testing just like we have been for the last 45 years.

From guidance in the creation of unique pilot studies and protocols, to evaluation of the safety and efficacy of your product, STILLMEADOW, Inc.’s experienced study directors and laboratory technicians support your IND drug development in meeting FDA guidelines for advancement to clinical trials.

  • Pharmacokinetic (PK) analysis of drug absorption, distribution, metabolism and excretion (ADME)
  • Acute and subchronic toxicological parameters
  • Dose range-finding studies
  • Multiple species
  • Creation of unique pilot studies and protocols to meet FDA guidelines

STILLMEADOW, Inc. performs pre-clinical safety and efficacy studies, pharmacokinetic studies, and ADME (adsorption, distribution, metabolism and excretion) studies.

Before testing a drug in people, researchers must find out whether it has the potential to cause serious harm, also called toxicity.  Starting with Acute screens and advancing to Sub Chronic studies we are available to help with your (IND) Initial New Drug development program.

FDA requires researchers to use good laboratory practices (GLP), defined in medical product development regulations, for preclinical laboratory studies.  The GLP regulations are found in 21 CFR Part 58.1: Good Laboratory Practice for Nonclinical Laboratory Studies. These regulations set the minimum basic requirements for:

  • study conduct
  • personnel
  • facilities
  • equipment
  • written protocols
  • operating procedures
  • study reports
  • and a system of quality assurance oversight for each study to help assure the safety of FDA-regulated product

Questions?
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