Clinical investigation of the pharmacokinetics of therapeutic proteins - Scientific guideline
Human
Scientific guidelines
This document underlines the specific problems related to the pharmacokinetics of protein products that need careful consideration during drug development.
Keywords: Therapeutic proteins, pharmacokinetics
Current effective version
Related content
- Clinical efficacy and safety: clinical pharmacology and pharmacokinetics
- Directive 2001/83/EC
Questions and answers: Positions on specific questions addressed to the Pharmacokinetics Working Party- Evaluation of the pharmacokinetics of medicinal products in patients with impaired hepatic function
- Evaluation of the pharmacokinetics of medicinal products in patients with decreased renal function
- ICH E3 Structure and content of clinical study reports
- ICH E6 (R1) Good clinical practice
- ICH E8 General considerations for clinical trials
- ICH S6 (R1) Preclinical safety evaluation of biotechnology-derived pharmaceuticals
- Investigation of bioequivalence
- Investigation of drug interactions
- Pharmacokinetic studies in man