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What are GLP preclinical studies and why are they important in drug development?

Unlike the early phases of pre-clinical research, drug safety studies should be completed using the recommended documentation procedures found in the GLP (Good Laboratory Practices) standards. GLP standards aim to produce records suitable for regulatory organizations. To learn more about GLP preclinical studies and why they are important for drug development, click on the links below.

• NCRR and Indiana University: Pharmacology & Toxicology – The Basics

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FDA Guidance

• FDA: Regulation Relating to Good Clinical Practice for Nonclinical Laboratory Studies
• FDA: Guidance on Pharm / Tox Studies
• FDA: Guidance on Clinical Pharmacology
• FDA: Guidance for Industry – Nonclinical Safety Studies for the Conduct of Human Clinical Trials for Pharmaceuticals

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