Key Principles of Pharmacology
5. Further Reading
- Guideline on Strategies to Identify and Mitigate Risks in First-in-Human Clinical Trials with investigational Medicinal Products
http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500002988.pdf
- Non-Clinical Safety Studies for the Conduct of Human Clinical Trials for Pharmaceuticals: link
- Preclinical safety evaluation of biotechnology-derived pharmaceuticals: here
- The Non-Clinical Evaluation of the Potential for delayed Ventricular Repolarisation (QT Interval Prolongation) by Human Pharmaceuticals: here
- Safety pharmacology studies for human pharmaceuticals: here
- Toxicokinetics: the assessment of systemic exposure in toxicology studies: here
- Position paper on the non-clinical safety studies to support clinical trials with a single micro dose: here
- Estimating the Maximum Safe Starting Dose in Initial Clinical Trials for Therapeutics in Adult Healthy Volunteers: here