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

More documents

Recommendations

Info

40Oral or Parenteralor TransdermalInhalation (generalanaesthetics,aerosols)Single dose orseveral doses inone day, Upto1wk> 1 wk but upto2wk> 2 wk but uptostudy isproposedto beconductedI,II,IIII,II,IIII,II,III2sp,2wk2sp;4wk2sp;12wk4wkOver 1mo I,II,III 2sp;24wkUpto 2 wk I,II,III 2sp;1mo; (Exposure time3h/d, 5d/wk)Upto 4wk I,II,III 2sp;12wk, (Exposure time6h/d, 5d/wk)> 1 4wk I,II,III 2sp;24wk, (Exposure time6h/d, 5d/wk)Local Toxicity StudiesDermal Upto 2 wk I,II 1sp;4wkIII2sp;4wk> 2 wk I,II,III 2sp;12wkOcular or Otic or Upto 2 wk I,II 1sp;4wkNasalIII2sp;4wk> 2 wk I,II,III 2sp;12wkVaginal or Rectal Upto 2 wk I,II 1sp;4wkIII2sp;4wk> 2 wk I,II,III 2sp;12wkSpecial Toxicity StudiesMale Fertility Study:• • Phase I, II, III in male volunteers/patients
41Female Reproduction and Developmental Toxicity Studies:• • Segment II studies in 2 species; Phase II, III involving female patients ofchild-bearing age.• • Segment I study; Phase III involving female patients of child-bearing age.• • Segment III study; Phase III for drugs to be given to pregnant or nursingmothers for long periods or where there are indications of possible adverseeffects on foetal development.Allergenicity/Hypersensitivity:• • Phase I, II, III - when there is a cause of concern or for parenteral drugs(including dermal application)Photo-allergy or dermal photo-toxicity:• • Phase I, II, III - if the drug or a metabolite is related to an agent causingphotosensitivity or the nature of action suggests such a potential.Genotoxicity:• • In-vitro studies - Phase I• • Both in-vitro and in-vivo - Phase II, IIIarcinogenicity:• • Phase III - when there is a cause for concern, or when the drug is to beused for more than 6 months.Abbreviations: sp-species; mo-month; wk-week; d -day; h-hour; I, II, III - Phases of clinicaltrial;Note:1.Animal toxicity data generated in other countries may be accepted and may notbe asked to be repeated/duplicated in India on a case to case basis depending uponthe quality of data and the credentials of the laboratory (ies) where such data hasbeen generated.2. Requirements for fixed dose combinations are given in Appendix VI.1.9 Number of animals required for repeated-dose toxicity studies14-28 days 84-182 daysGroup Rodent (Rat) Non-rodent Rodent (Rat) Non-rodent(Dog or(Dog orMonkey)Monkey)M F M F M F M FControl 6- 6-10 2-3 2-3 15- 15- 4-6 4-6
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: 39At least three dose levels should
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 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

You also want an ePaper? Increase the reach of your titles

Delete template?

Save as template?