3 In the Drugs and Cosmetics Rules, 1945 - amam-ayurveda.org

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72Start date (and time) of onset of reactionStop date (and time) or duration of reactionDechallenge and rechallenge informationSetting (e.g., hospital, out-patient clinic, home, nursing home)5. OutcomeInformation on recovery and any sequelae; results of specific tests and/or treatment that mayhave been conductedFor a fatal outcome, cause of death and a comment on its possible relationship to the suspectedreaction; Any post-mortem findings.Other information: anything relevant to facilitate assessment of the case, such as medicalhistory including allergy, drug or alcohol abuse; family history; findings from specialinvestigations etc.6. Details about the Investigator*NameAddressTelephone numberProfession (specialty)Date of reporting the event to Licensing Authority:Date of reporting the event to Ethics Committee overseeing the site:Signature of the InvestigatorNote: Information marked * must be provided.”
73(F.No. X-11014/1/2003-DMS & PFA)(RITA TEOTIA),JOINT SECRETARY, GOVERNMENT OF INDIAFoot Note :- The Prinicipal Rules were published in the Official Gazette vide notificationNo. F. 28-10/45-H(I), dated the 21 st December, 1945 and last amended videG.S.R. (E) dated the
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42. CLINICAL TRIAL(1) Approval for
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7(5) Responsibilities of the Ethics
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9study and to determine the common
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11(1) Geriatrics.-Geriatric patient
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13(viii)For clinical trials conduct
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15(ii) Evaluation of the effect of
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172.6. 2.6. Stability Studies (for
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198.2. 8.2. Bio-availability / Bio-
Page 21 and 22: 21brief description of the trial de
Page 23 and 24: 2315. List of References16. Appendi
Page 25 and 26: 25whichever is higher) is recommend
Page 27 and 28: 27hours. Animals should be observed
Page 29 and 30: 29showing minimal toxicity in syste
Page 31 and 32: 31One male and one female from each
Page 33 and 34: 33taken. Formulation in volume comp
Page 35 and 36: 35the same route in a batch of 4 ma
Page 37 and 38: 37(i) (i) In-vitro exposure (with a
Page 39 and 40: 39At least three dose levels should
Page 41 and 42: 41Female Reproduction and Developme
Page 43 and 44: 43Reaction(pH)• • Bilepigments
Page 45 and 46: 45Allergenicity/Hypersensitivity te
Page 47 and 48: 47Specific and general pharmacologi
Page 49 and 50: 49These include ventricular contrac
Page 51 and 52: 511.6 Application Of Good Laborator
Page 53 and 54: 5313. Statement that participation
Page 55 and 56: 55Signatory’s Name: _____________
Page 57 and 58: 57Appendix VIIUNDERTAKING BY THE IN
Page 59 and 60: 59(ix) I agree to promptly report t
Page 61 and 62: 612. Format for Approval of Ethics
Page 63 and 64: 63Appendix IXSTABILITY TESTING OF N
Page 65 and 66: 65(i) Study conditions for drug sub
Page 67 and 68: 67Previous clinical work with the n
Page 69 and 70: 69d. Possible drug interactionse. C
Page 71: 71Appendix XIData Elements for repo
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3 In the Drugs and Cosmetics Rules, 1945 - amam-ayurveda.org

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