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- 1. §§¯§¿§¬ ¨C §Ú§ã§ã§Ý§Ö§Õ§à§Ó§Ñ§ä§Ö§Ý§î: §ã§à§ä§â§å§Õ§ß§Ú§é§Ö§ã§ä§Ó§à §Ú§Ý§Ú ?§á§Ñ§Ý§Ü§Ñ §Ó §Ü§à§Ý§Ö§ã§Ö? - §à§á§í§ä §â§Ñ§Ò§à§ä§í §§¯§¿§¬ §¯§¸§©§¥ §®§Ñ§ã§Ý§à§Ó§Ñ §°.§ª.,§¯§Ñ§Þ§Ñ§Ù§à§Ó§Ñ-§¢§Ñ§â§Ñ§ß§à§Ó§Ñ §.§³., §´§Ñ§Û§Ò§å§Ý§Ñ§ä§à§Ó §¯.§ª., §¥§Ö§ß§Ú§ã§à§Ó§Ñ §².§£., §²§å§Ù§Ñ§Ö§Ó§Ñ §¦.§±. §¶§¤§¢§¯§µ §¯§Ñ§å§é§ß§í§Û §è§Ö§ß§ä§â §Ù§Õ§à§â§à§Ó§î§ñ §Õ§Ö§ä§Ö§Û 6 §Ñ§á§â§Ö§Ý§ñ 2015§Ô.
- 3. §§à§Ü§Ñ§Ý§î§ß§í§Û §¯§Ö§Ù§Ñ§Ó§Ú§ã§Ú§Þ§í§Û §¿§ä§Ú§é§Ö§ã§Ü§Ú§Û §¬§à§Þ§Ú§ä§Ö§ä = §§¯§¿§¬ §±§â§Ú§Ü§Ñ§Ù §à §ã§à§Ù§Õ§Ñ§ß§Ú§Ú §§¯§¿§¬ §¶§¤§¢§¯§µ §¯§¸§©§¥ (§ß§Ñ 5 §Ý§Ö§ä, +§ß§Ö §Þ§Ö§Õ§Ú§Ü, +§ß§Ö §â§Ñ§Ò§à§ä§Ñ§ð§ë§Ú§Û §Ó §è§Ö§ß§ä§â§Ö) §³§°§±: §Ô§à§Ý§à§ã§à§Ó§Ñ§ß§Ú§Ö §á§à §á§Ö§â§Ó§Ú§é§ß§à§Û §Õ§à§Ü§å§Þ§Ö§ß§ä§Ñ§è§Ú§Ú=50% §à§ä §ã§à§ã§ä§Ñ§Ó§Ñ §§¯§¿§¬ + 2§é§Ö§Ý§à§Ó§Ö§Ü§Ñ §Ú§Ù §ã§à§ã§ä§Ñ§Ó§Ñ §§¯§¿§¬
- 4. §¬§Ñ§Õ§â§í §á§â§à§Ó§Ö§Õ§Ö§ß§Ú§ñ §¬§ª §Ú §¯§ª§² -§ã§á§Ú§ã§à§Ü §Ô§Ý§Ñ§Ó§ß§í§ç §Ú§ã§ã§Ý§Ö§Õ§à§Ó§Ñ§ä§Ö§Ý§Ö§Û -§ã§á§Ú§ã§à§Ü §ã§à§Ú§ã§ã§Ý§Ö§Õ§à§Ó§Ñ§ä§Ö§Ý§Ö§Û -§Þ§à§ß§Ú§ä§à§â§Ú§ß§Ô §ã§Ö§â§ä§Ú§æ§Ú§Ü§Ñ§ä§à§Ó GCP -§Ý§Ö§Ü§è§Ú§Ú §Ú §Ù§Ñ§ß§ñ§ä§Ú§ñ §ã§à §ã§ä§Ñ§â§ê§Ú§Þ§Ú §ã§×§ã§ä§â§Ñ§Þ§Ú, §Ù§Ñ§Ó.§Ñ§á§ä§Ö§Ü§à§Û, ¡¡¡. -§ã§á§Ú§ã§Ü§Ú §Ñ§ã§á§Ú§â§Ñ§ß§ä§à§Ó, §Õ§à§Ü§ä§à§â§Ñ§ß§ä§à§Ó, §ã§à§Ú§ã§Ü§Ñ§ä§Ö§Ý§Ö§Û
- 5. §²§Ñ§Ù§â§Ö§ê§Ñ§ð§ë§Ú§Ö §Õ§à§Ü§å§Þ§Ö§ß§ä§í: - §á§â§à§Ó§Ö§â§Ü§Ñ §ß§Ñ§Ý§Ú§é§Ú§ñ 5-§Ý§Ö§ä§ß§Ö§Ô§à §ã§ä§Ñ§Ø§Ñ §â§Ñ§Ò§à§ä§í §á§à §á§â§à§æ§Ú§Ý§ð §¬§ª - §á§â§à§Ó§Ö§â§Ü§Ñ §ß§Ñ§Ý§Ú§é§Ú§ñ §ã§Ö§â§ä§Ú§æ§Ú§Ü§Ñ§ä§Ñ §á§à §á§â§à§ç§à§Ø§Õ§Ö§ß§Ú§ð ?§¯§Ñ§Õ§Ý§Ö§Ø§Ñ§ë§Ö§Û §Ü§Ý§Ú§ß§Ú§é§Ö§ã§Ü§à§Û §á§â§Ñ§Ü§ä§Ú§Ü§Ú? (GCP)
- 6. §±§â§à§ç§à§Ø§Õ§Ö§ß§Ú§Ö §è§Ú§Ü§Ý§à§Ó §á§à GCP -§á§à§ã§ä§à§ñ§ß§ß§í§Û §Þ§à§ß§Ú§ä§à§â§Ú§ß§Ô §ã§à§ä§â§å§Õ§ß§Ú§Ü§à§Ó + §Ñ§ã§á§Ú§â§Ñ§ß§ä§í, §Õ§à§Ü§ä§à§â§Ñ§ß§ä§í, §ã§à§Ú§ã§Ü§Ñ§ä§Ö§Ý§Ú §©§Ñ §á§à§ã§Ý§Ö§Õ§ß§Ú§Ö 5 §Ý§Ö§ä §à§Ò§å§é§Ö§ß§Ú§Ö §á§â§à§ê§Ý§Ú 211§ã§à§ä§â§å§Õ§ß§Ú§Ü§à§Ó (§ã§Ö§â§ä§Ú§æ§Ú§Ü§Ñ§ä §Õ§Ö§Û§ã§ä§Ó§Ú§ä§Ö§Ý§Ö§ß 5 §Ý§Ö§ä, §ß§Ñ§Õ§à ?§Ò§Õ§Ú§ä§î?, §Ö§ã§Ý§Ú §à§ß §Ù§Ñ§Ü§Ñ§ß§é§Ú§Ó§Ñ§Ö§ä§ã§ñ §Ó §á§â§à§è§Ö§ã§ã§Ö §Õ§Ñ§ß§ß§à§Ô§à §¬§ª)5
- 7. §§à§Ü§Ñ§Ý§î§ß§Ñ§ñ §Õ§à§Ü§å§Þ§Ö§ß§ä§Ñ§è§Ú§ñ -§ã§à§Ù§Õ§Ñ§ß§Ñ §©§Ñ§ñ§Ó§Ü§Ñ §Ó §§¯§¿§¬ §ß§Ñ §¬§ª -§ã§à§Ù§Õ§Ñ§ß§í §Ý§à§Ü§Ñ§Ý§î§ß§í§Ö §Õ§à§Ü§å§Þ§Ö§ß§ä§í §á§â§Ú §á§à§Õ§Ñ§é§Ö §á§Ö§â§Ó§Ú§é§ß§à§Û §Õ§à§Ü§å§Þ§Ö§ß§ä§Ñ§è§Ú§Ú, §à§Ò§ñ§Ù§Ñ§ä§Ö§Ý§î§ß§à §á§â§à§ã§Ú§Þ §æ§Ú§â§Þ§å §á§â§Ú§Ü§Ý§Ñ§Õ§í§Ó§Ñ§ä§î §Õ§Ú§ã§Ü §ã §Õ§à§Ü§å§Þ§Ö§ß§ä§Ñ§Þ§Ú!!! -§ã§à§Ù§Õ§Ñ§ß §Ñ§Ý§Ô§à§â§Ú§ä§Þ §Õ§Ö§Û§ã§ä§Ó§Ú§Û §Ú §Õ§à§Ü§å§Þ§Ö§ß§ä§à§Ó §Ó §ã§Ý§å§é§Ñ§Ö §Ú§ã§á§à§Ý§î§Ù§à§Ó§Ñ§ß§Ú§ñ §á§â§Ö§á§Ñ§â§Ñ§ä§à§Ó off label -§ã§æ§à§â§Þ§Ú§â§à§Ó§Ñ§ß§í §Õ§à§Ü§å§Þ§Ö§ß§ä§í §Õ§Ý§ñ §Ñ§ã§á§Ú§â§Ñ§ß§ä§à§Ó, §Õ§à§Ü§ä§à§â§Ñ§ß§ä§à§Ó, §ã§à§Ú§ã§Ü§Ñ§ä§Ö§Ý§Ö§Û §á§â§Ú §å§ä§Ó§Ö§â§Ø§Õ§Ö§ß§Ú§Ú §ä§Ö§Þ§í §Õ§Ú§ã§ã§Ö§â§ä§Ñ§è§Ú§Ú
- 8. §±§â§Ú§×§Þ §á§Ö§â§Ó§Ú§é§ß§à§Û §Õ§à§Ü§å§Þ§Ö§ß§ä§Ñ§è§Ú§Ú -§Ñ§ß§Ñ§Ý§Ú§Ù §á§â§Ö§Õ§ã§ä§Ñ§Ó§Ý§Ö§ß§ß§à§Û §Õ§à§Ü§å§Þ§Ö§ß§ä§Ñ§è§Ú§Ú (§à§ã§à§Ò§Ö§ß§ß§à §ª§, §ª§³, §á§â§à§ä§à§Ü§à§Ý§Ñ, §Ü§â§Ú§ä§Ö§â§Ú§Ö§Ó §Ó§Ü§Ý§ð§é§Ö§ß§Ú§ñ-§Ú§ã§Ü§Ý§ð§é§Ö§ß§Ú§ñ) +§Ñ§ß§Ñ§Ý§Ú§Ù §Õ§à§Ü§å§Þ§Ö§ß§ä§à§Ó §Õ§Ý§ñ §§¯§¿§¬ §à§ä §Ô§Ý§Ñ§Ó§ß§à§Ô§à §Ú§ã§ã§Ý§Ö§Õ§à§Ó§Ñ§ä§Ö§Ý§ñ +§á§à§Ý§å§é§Ö§ß§Ú§Ö §à§ä§Ó§Ö§ä§à§Ó §ß§Ñ §Ó§à§á§â§à§ã§í §é§Ý§Ö§ß§à§Ó §§¯§¿§¬ (3 §Ú§ã§ã§Ý§Ö§Õ§à§Ó§Ñ§ß§Ú§ñ §Ò§í§Ý§Ú §à§ä§Ü§Ý§à§ß§Ö§ß§í §Ú§Ù-§Ù§Ñ §ß§Ö§ï§ä§Ú§é§ß§à§Ô§à §à§æ§à§â§Þ§Ý§Ö§ß§Ú§ñ §á§â§à§ä§à§Ü§à§Ý§Ñ)
- 9. §²§Ñ§Ù§Õ§Ö§Ý 8 §¯§Ñ§è§Ú§à§ß§Ñ§Ý§î§ß§à§Ô§à §ã§ä§Ñ§ß§Õ§Ñ§â§ä§Ñ §²§¶ ?§¯§Ñ§Õ§Ý§Ö§Ø§Ñ§ë§Ñ§ñ §Ü§Ý§Ú§ß§Ú§é§Ö§ã§Ü§Ñ§ñ §á§â§Ñ§Ü§ä§Ú§Ü§Ñ? §°§ã§ß§à§Ó§ß§í§Ö §Õ§à§Ü§å§Þ§Ö§ß§ä§í §Õ§Ý§ñ §á§â§à§Ó§Ö§Õ§Ö§ß§Ú§ñ §Ü§Ý§Ú§ß§Ú§é§Ö§ã§Ü§à§Ô§à §Ú§ã§ã§Ý§Ö§Õ§à§Ó§Ñ§ß§Ú§ñ: 8.2 ¨C§á§Ö§â§Ö§Õ §ß§Ñ§é§Ñ§Ý§à§Þ §Ü§Ý§Ú§ß§Ú§é§Ö§ã§Ü§à§Û §æ§Ñ§Ù§í §Ú§ã§ã§Ý§Ö§Õ§à§Ó§Ñ§ß§Ú§ñ 8.3 ¨C §Ó§à §Ó§â§Ö§Þ§ñ §Ü§Ý§Ú§ß§Ú§é§Ö§ã§Ü§à§Û §æ§Ñ§Ù§í §Ú§ã§ã§Ý§Ö§Õ§à§Ó§Ñ§ß§Ú§ñ - §â§Ñ§Ò§à§ä§Ñ §ã§à §Ó§ä§à§â§Ú§é§ß§à§Û §Õ§à§Ü§å§Þ§Ö§ß§ä§Ñ§è§Ú§Ö§Û !!!!! 8.4 ¨C§á§à§ã§Ý§Ö §Ù§Ñ§Ó§Ö§â§ê§Ö§ß§Ú§ñ §Ú§Ý§Ú §á§â§Ö§Ü§â§Ñ§ë§Ö§ß§Ú§ñ §Ú§ã§ã§Ý§Ö§Õ§à§Ó§Ñ§ß§Ú§ñ (§ß§Ñ§Ú§Þ§Ö§ß§à§Ó§Ñ§ß§Ú§Ö §Õ§à§Ü§å§Þ§Ö§ß§ä§Ñ, §è§Ö§Ý§î, §ß§Ñ§ç§à§Õ§Ú§ä§ã§ñ §Ó §æ§Ñ§Û§Ý§Ñ§ç §Ú§ã§ã§Ý§Ö§Õ§à§Ó§Ñ§ä§Ö§Ý§ñ/§ã§á§à§ß§ã§à§â§Ñ)
- 10. §¦§Ø§Ö§Ô§à§Õ§ß§í§Ö §á§â§à§Ó§Ö§â§Ü§Ú §§¯§¿§¬ -§á§â§Ö§Õ§å§á§â§Ö§Õ§Ú§ä§î (?§á§Ö§â§î§ñ §á§à§é§Ú§ã§ä§Ú§ä§î?) -§á§à§Þ§à§é§î -§å§ß§Ú§é§ä§à§Ø§Ö§ß§Ú§Ö §Õ§à§Ü§å§Þ§Ö§ß§ä§Ñ§è§Ú§Ú -§á§â§à§Ó§Ö§â§Ú§ä§î: §à§æ§à§â§Þ§Ý§Ö§ß§Ú§Ö §Ú§Ù§Þ§Ö§ß§Ö§ß§Ú§ñ §ã§à§ã§ä§Ñ§Ó§Ñ §Ú§ã§ã§Ý§Ö§Õ§à§Ó§Ñ§ä§Ö§Ý§Ö§Û, §ã§Ö§â§ä§Ú§æ§Ú§Ü§Ñ§ä§Ñ §à §ã§á§Ö§è§Ú§Ñ§Ý§Ú§Ù§Ñ§è§Ú§Ú, §Ô§à§Õ§ß§à§ã§ä§î §ã§Ö§â§ä§Ú§æ§Ú§Ü§Ñ§ä§Ñ GCP, §Õ§â§å§Ô§à§Ö¡¡..
- 11. §´§Ö§Ü§å§ë§Ñ§ñ §â§Ñ§Ò§à§ä§Ñ §ã §ã§à§ä§â§å§Õ§ß§Ú§Ü§Ñ§Þ§Ú: -§ã§à§Ò§Ý§ð§Õ§Ö§ß§Ú§Ö §á§â§Ñ§Ó§Ú§Ý §ç§â§Ñ§ß§Ö§ß§Ú§ñ §ä§Ö§Ü§å§ë§Ö§Û §Õ§à§Ü§å§Þ§Ö§ß§ä§Ñ§è§Ú§Ú §¬§ª -§ß§Ñ§Ý§Ú§é§Ú§Ö §ã§á§Ö§è§ê§Ü§Ñ§æ§à§Ó §Ó §à§ä§Õ§Ö§Ý§Ö§ß§Ú§ñ§ç -§æ§à§â§Þ§Ú§â§à§Ó§Ñ§ß§Ú§Ö §Õ§à§Ü§å§Þ§Ö§ß§ä§à§Ó §Ù§Ñ§Ü§à§ß§é§Ö§ß§ß§à§Ô§à §¬§ª (§Ö§ã§ä§î §Ñ§â§ç§Ú§Ó, §ã§á§Ö§è§Ü§à§â§à§Ò§Ü§Ú) -§Ö§ã§ä§î §á§Ö§é§Ñ§ä§Ú §Ú §ê§ä§Ñ§Þ§á§í -§ç§â§Ñ§ß§Ú§Þ §Õ§à§Ü§å§Þ§Ö§ß§ä§í §ä§Ö§á§Ö§â§î, §Ó §â§ñ§Õ§Ö §ã§Ý§å§é§Ñ§Ö§Ó, §Ò§Ö§ã§ã§â§à§é§ß§à -§Õ§à§Ó§Ö§Õ§Ö§ß§Ú§Ö §Õ§à §ã§Ó§Ö§Õ§Ö§ß§Ú§ñ §ß§à§Ó§í§ç §á§â§Ú§Ü§Ñ§Ù§à§Ó §®§©, §³§à§Ó§Ö§ä§à§Ó §á§à §¿§ä§Ú§Ü§Ö 10
- 12. §§¯§¿§¬ §Ú §ã§à§ä§â§å§Õ§ß§Ú§Ü§Ú -§Ö§ã§ä§î §á§à§ã§ä§à§ñ§ß§ß§í§Û §Ü§Ñ§Ò§Ú§ß§Ö§ä -§Ö§ã§ä§î §ï§Ý§Ö§Ü§ä§â§à§ß§ß§Ñ§ñ §á§à§é§ä§Ñ -§Ö§ã§ä§î §ã§ä§Ö§ß§Õ §ã §Ú§ß§æ§à§â§Þ§Ñ§è§Ú§à§ß§ß§í§Þ§Ú §Þ§Ñ§ä§Ö§â§Ú§Ñ§Ý§Ñ§Þ§Ú (§Ó §Ô§Ý§Ñ§Ó§ß§à§Þ §Ü§à§â§á§å§ã§Ö) -§ã§Ó§ñ§Ù§í§Ó§Ñ§Ö§Þ§ã§ñ §á§à §ï§Ý§á§à§é§ä§Ö, §Þ§Ö§ã§ä§ß§í§Þ §Ú §Þ§à§Ò§Ú§Ý§î§ß§í§Þ §ä§Ö§Ý§Ö§æ§à§ß§Ñ§Þ -§á§à§Ý§å§é§Ñ§Ö§Þ §Ú§ß§æ§à§â§Þ§Ñ§è§Ú§ð §à§ä §Ú§ã§ã§Ý§Ö§Õ§à§Ó§Ñ§ä§Ö§Ý§Ö§Û §à §Ó§Ú§Ù§Ú§ä§Ñ§ç §Þ§à§ß§Ú§ä§à§â§Ñ, §Ñ§å§Õ§Ú§ä§Ö -§§¯§¿§¬ §Ú§ß§æ§à§â§Þ§Ú§â§å§Ö§ä §à §ß§à§Ó§í§ç §Õ§à§Ü§å§Þ§Ö§ß§ä§Ñ§ç (§Ú§Ù§Þ§Ö§ß§Ö§ß§Ú§ñ§ç §Ó §ã§à§ã§ä§Ñ§Ó§Ö §§¯§¿§¬, §ß§Ñ§Ù§Ó§Ñ§ß§Ú§ñ §è§Ö§ß§ä§â§Ñ, §Ú§Ù§Þ§Ö§ß§Ö§ß§Ú§ñ§ç §Ó §³§°§±)
- 13. §±§à§Þ§à§ë§î §Ú§ã§ã§Ý§Ö§Õ§à§Ó§Ñ§ä§Ö§Ý§ñ§Þ - §Ó §á§Ö§â§Ö§á§Ú§ã§Ü§Ö ( §á§â§Ú§Þ§Ö§â ¨C §â§Ñ§Ò§à§ä§Ñ §ã §á§â§à§Ü§å§â§à§â§à§Þ) - §Ó §ã§à§Ù§Õ§Ñ§ß§Ú§Ú §ª§ §Ú §ª§³ §Õ§Ý§ñ §Õ§Ú§ã§ã§Ö§â§ä§Ñ§è§Ú§à§ß§ß§í§ç §â§Ñ§Ò§à§ä - §á§â§Ú §à§æ§à§â§Þ§Ý§Ö§ß§Ú§Ú §á§Ñ§Ü§Ö§ä§Ñ §Õ§à§Ü§å§Þ§Ö§ß§ä§à§Ó, §Ó §ã§Ý§å§é§Ñ§Ö §ß§Ö§à§Ò§ç§à§Õ§Ú§Þ§à§ã§ä§Ú §Ú§ã§á§à§Ý§î§Ù§à§Ó§Ñ§ß§Ú§ñ §á§â§Ö§á§Ñ§â§Ñ§ä§à§Ó off label, §à§Ò§ñ§Ù§Ñ§ä§Ö§Ý§î§ß§Ñ§ñ §á§â§à§Ó§Ö§â§Ü§Ñ §á§â§Ö§á§Ñ§â§Ñ§ä§Ñ §á§à §²§§³ (§ß§Ö §á§à §£§Ú§Õ§Ñ§Ý§ð §Ú §Õ§â§å§Ô§Ú§Þ §ã§á§â§Ñ§Ó§à§é§ß§Ú§Ü§Ñ§Þ) - §Ü §á§â§à§Ó§Ö§â§Ü§Ñ§Þ §²§°§³§©§¥§¡§£§¯§¡§¥§©§°§²§¡
- 14. §³§Ý§à§Ø§ß§à§ã§ä§î: §à§æ§à§â§Þ§Ý§Ö§ß§Ú§Ö §ã§ä§Ñ§ä§Ö§Û §é§Ö§â§Ö§Ù §§¯§¿§¬ ???