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

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162. 2. Chemical and pharmaceutical information2.1. 2.1. Information on active ingredientsDrug information (Generic Name, Chemical Name or INN)2.2. 2.2. Physicochemical Dataa. Chemical name and StructureEmpirical formulaMolecular weightb. Physical propertiesDescriptionSolubilityRotationPartition coefficientDissociation constant2.3. 2.3. Analytical DataElemental analysisMass spectrumNMR spectraIR spectraUV spectraPolymorphic identification2.4. 2.4. Complete monograph specification includingIdentificationIdentity/quantification of impuritiesEnantiomeric purityAssay2.5. 2.5. ValidationsAssay methodImpurity estimation methodResidual solvent/other volatile impurities (OVI) estimation method
172.6. 2.6. Stability Studies (for details refer Appendix IX)Final release specificationReference standard characterizationMaterial safety data sheet2.7. 2.7. Data on FormulationDosage formCompositionMaster manufacturing formulaDetails of the formulation (including inactive ingredients)In process quality control checkFinished product specificationExcipient compatibility studyValidation of the analytical methodComparative evaluation with international brand(s) or approved Indian brands, ifapplicablePack presentationDissolutionAssayImpuritiesContent uniformitypHForce degradation studyStability evaluation in market intended pack at proposed storage conditionsPacking specificationsProcess validationWhen the application is for clinical trials only, the international non-proprietary name (INN)or generic name, drug category, dosage form and data supporting stability in the intendedcontainer-closure system for the duration of the clinical trial (information covered in item nos.2.1, 2.3, 2.6, 2.7) are required.3. 3. Animal Pharmacology (for details refer Appendix IV)
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: 15(ii) Evaluation of the effect of
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 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)(
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3 In the Drugs and Cosmetics Rules, 1945 - amam-ayurveda.org

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