3 In the Drugs and Cosmetics Rules, 1945 - amam-ayurveda.org
3 In the Drugs and Cosmetics Rules, 1945 - amam-ayurveda.org
3 In the Drugs and Cosmetics Rules, 1945 - amam-ayurveda.org
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183.1. 3.1. Summary3.2. 3.2. Specific pharmacological actions3.3. 3.3. General pharmacological actions3.4. 3.4. Follow-up <strong>and</strong> Supplemental Safety Pharmacology Studies3.5. 3.5. Pharmacokinetics: absorption, distribution; metabolism; excretion4. 4. Animal Toxicology (for details refer Appendix III)4.1. 4.1. General Aspects4.2. 4.2. Systemic Toxicity Studies4.3. 4.3. Male Fertility Study4.4. 4.4. Female Reproduction <strong>and</strong> Developmental Toxicity Studies4.5. 4.5. Local toxicity4.6. 4.6. Allergenicity/Hypersensitivity4.7. 4.7. Genotoxicity4.8. 4.8. Carcinogenicity5. 5. Human / Clinical pharmacology (Phase I)5.1. 5.1. Summary5.2. 5.2. Specific Pharmacological effects5.3. 5.3. General Pharmacological effects5.4. 5.4. Pharmacokinetics, absorption, distribution, metabolism, excretion5.5. 5.5. Pharmacodynamics / early measurement of drug activity6. 6. Therapeutic exploratory trials (Phase II)6.1. 6.1. Summary6.2. 6.2. Study report(s) as given in Appendix II7. 7. Therapeutic confirmatory trials (Phase III)7.1. 7.1. Summary7.2. 7.2. <strong>In</strong>dividual study reports with listing of sites <strong>and</strong> <strong>In</strong>vestigators.8. 8. Special studies8.1. 8.1. Summary
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