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

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501.4 Conditions Under Which Safety Pharmacology Studies Are NotNecessarySafety pharmacology studies are usually not required for locally applied agentse.g. dermal or ocular, in cases when the pharmacology of the investigationaldrug is well known, and/or when systemic absorption from the site ofapplication is low. Safety pharmacology testing is also not necessary, in thecase of a new derivative having similar pharmacokinetics andpharmacodynamics.1.5 Timing Of Safety Pharmacology Studies In Relation To ClinicalDevelopment1.5.1 Prior To First Administration In HumansThe effects of an investigational drug on the vital functions listed in theessential safety pharmacology should be studied prior to first administration inhumans. Any follow-up or supplemental studies identified, should beconducted if necessary, based on a cause for concern.1.5.2 During Clinical DevelopmentAdditional investigations may be warranted to clarify observed or suspectedadverse effects in animals and humans during clinical development.1.5.3 Before applying for marketing ApprovalFollow-up and supplemental safety pharmacology studies should be assessedprior to approval unless not required, in which case this should be justified.Available information from toxicology studies addressing safety pharmacologyendpoints or information from clinical studies can replace such studies.
511.6 Application Of Good Laboratory Practices (GLP)The animal studies be conducted in an accredited laboratory. Where the safetypharmacology studies are part of toxicology studies, these studies should also beconducted in an accredited laboratory.
Page 4 and 5: 42. CLINICAL TRIAL(1) Approval for
Page 7 and 8: 7(5) Responsibilities of the Ethics
Page 9 and 10: 9study and to determine the common
Page 11 and 12: 11(1) Geriatrics.-Geriatric patient
Page 13 and 14: 13(viii)For clinical trials conduct
Page 15 and 16: 15(ii) Evaluation of the effect of
Page 17 and 18: 172.6. 2.6. Stability Studies (for
Page 19 and 20: 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: 49These include ventricular contrac
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 and 72: 71Appendix XIData Elements for repo
Page 73: 73(F.No. X-11014/1/2003-DMS & PFA)(

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

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