Guidelines for Evaluation of Drugs for Use in Man
İÇİNDEKİLERCONTENTS 1. Introduction........................ 2. General considerations ................... 2.1 Introductory comments................. 2.2 Steps in the development of a drug............ 2.3 Chemical and pharmaceutical aspects........... 2.4 Application of statistical procedures........... 3. Pre-clinical studies ..................... 3.1 General comments................... 3.2 Pre-clinical pharmacology................ 3.2.1 Pharmacodynamics............... 3.2.2 Pharmacokinetics................ 3.3 Pre-clinical toxicology................. 3.3.1 General comments............... 3.3.2 The drug.................... 3.3.3 Animals used ................. 3.3.4 Problems in the concurrent use of two or more drugs 3.3.5 Acute toxicity ................. 3.3.6 Long-term toxicity............... 3.4 Special toxicological studies............... 3.4.1 General comments ............... 3.4.2 Reproduction including teratogenicity....... 3.4.3 Carcinogenicity................. 3.4.4 Mutagenicity.................. 3.4.5 Relationship of mutagenesis and carcinogenesis . . . 3.4.6 Dependence liability .............. 4. Clinical evaluation............. 4.1 Ethical and legal aspects........ 4.1.1 Drugs for children....... 4.2 Early studies in man.......... 4.2.1 Justification and purpose..... 4.2.2 The first study in man...... 4.2.3 Clinical and laboratory facilities . . 4.2.4 Clinical and laboratory observations 4.2.5 Qualifications of the investigator. . 4.2.6 The clinical pharmacologist . . . 4.2.7 Experimental design....... 4.3 Controlled therapeutic trials....... 4.3.1 Principles........... 4.3.2 Experimental methods...... 4.3.3 Evaluation of results....... 4.4 Pharmacogenetics........... 4.5 Unavailability.............5. Post-registration surveillance........... 5.1 General comments............. 5.2 Monitored release............. 5.3 Monitoring of adverse reactions....... 5.4 Monitoring for efficacy........... 5.5 Information from poisonings and overdosage . 5.6 Continuing evaluation........... 5.7 New indications for registered drugs..... 5.8 Information for and education of the physician 6. Future research needs and further activities..... 6.1 Research................. 6.2 Further activities to be undertaken by WHO . References....................  |
