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

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66(iv) Drug substances intended for storage below -20°C shall be treated on acase-by-case basis.(v)Stability testing of the formulation after constitution or dilution, if applicable,should be conducted to provide information for the labeling on the preparation,storage condition, and in-use period of the constituted or diluted product. Thistesting should be performed on the constituted or diluted product through theproposed in-use period.Appendix XTRIALSCONTENTS OF THE PROPOSED PROTOCOL FOR CONDUCTING CLINICAL1. Title Pagea. Full title of the clinical study,b. Protocol / Study number, and protocol version number with datec. The IND name/number of the investigational drugd. Complete name and address of the Sponsor and contract researchorganization if anye. List of the Investigators who are conducting the study, their respectiveinstitutional affiliations and site locationsf. Name(s) of clinical laboratories and other departments and/or facilitiesparticipating in the study.2. Table of ContentsA complete Table of Contents including a list of all Appendices.1. 1. Background and Introductiona. a. Preclinical experienceb. b. Clinical experience
67Previous clinical work with the new drug should be reviewed here and a description ofhow the current protocol extends existing data should be provided. If this is an entirelynew indication, how this drug was considered for this should be discussed. Relevantinformation regarding pharmacological, toxicological and other biological propertiesof the drug/biologic/medical device, and previous efficacy and safety experienceshould be described.2. 2. Study RationaleThis section should describe a brief summary of the background information relevantto the study design and protocol methodology. The reasons for performing this studyin the particular population included by the protocol should be provided.3. Study Objective(s) (primary as well as secondray) and their logical relation to thestudy design.3. 3. Study Designa. Overview of the Study Design: Including a description of the type of study(i.e., double-blind, multicentre, placebo controlled, etc.), a detail of the specifictreatment groups and number of study Subjects in each group and investigativesite, Subject number assignment, and the type, sequence and duration of studyperiods.b. Flow chart of the studyc. A brief description of the methods and procedures to be used during the study.d. Discussion of Study Design: This discussion details the rationale for the designchosen for this study.5. Study Population: the number of Subjects required to be enrolled in the study at theinvestigative site and by all sites along with a brief description of the nature of the Subjectpopulation required is also mentioned.6. Subject Eligibility
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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
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 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: 65(i) Study conditions for drug sub
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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