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

More documents

Recommendations

Info

4210 30 30Low dose 6-106-10 2-3 2-3 15-3015-30Intermediate 6- 6-10 2-3 2-3 15- 15-dose1030 30High dose 6- 6-10 2-3 2-3 15- 15-1030 304-6 4-64-6 4-64-6 4-62.0 Laboratory parameters to be included in toxicity studies.Haematological parameters• •• • Total • •• •HaemoglobinRBC Count HaematocritReticulocyte Count• • Total • •• •• •WBC CountDifferentialWBC CountPlatelet Count TerminalBoneMarrowExamination• • ESR • • General Blood Picture: A special mention of abnormal(Non-rodentsand immature cells should be made.only)• • Coagulation Parameters (Non-rodents only): Bleeding Time, Coagulation Time,Prothrombin Time, Activated Partial Thromboplastin TimeUrinalysis Parameters• •• •• •• • 24-ColourAppearance SpecificGravityhour urinaryoutput• • • • • • • •
43Reaction(pH)• • Bilepigments• •Albumin Sugar AcetoneUrobilinogen• •OccultBlood• • Microscopic examination of urinary sediment.Blood Biochemical Parameters• •• •• •• • HDLGlucoseCholesterolTriglycerideCholesterols(Non-rodents• • LDL• •• •only)• • SGOTCholesterolBilirubinSGPT(AST)(Non-rodents(ALT)only)• •• • GGT• •• •Alkaline(Non-rodentsBlood UreaCreatininePhosphataseonly)Nitrogen(ALP)• • Total• •• •• • SodiumProteinsAlbuminGlobulin(Calculated• •• •values)• •PotassiumPhosphorusCalciumGross and Microscopic Pathology• •Brain*:Cerebrum,cerebellum,Midbrain• •Thyroid• •Adrenal*• •(Spinal Cord)• •(Parathyroid)• •(Pancreas)• • Eye • • (MiddleEar)• •• •Spleen*Thymus• •• • Lung*(Trachea)
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: 41Female Reproduction and Developme
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?