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Schedule Y Appendices Clinical Trial Data

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Kirti Krishna
Kirti Krishna

Schedule Y ( A standard Guidelines for Conduct Clinical Trial in India )

Gesundheit & MedizinBusinessTechnologie
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Schedule Y By: Kirtikrushna
Appendices ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Appendices ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
APPENDIX I ,[object Object]
APPENDIX I ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
APPENDIX I ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
2.2. Physicochemical Data ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
2.3.      Analytical Data ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
2.4. Complete monograph specification including ,[object Object],[object Object],[object Object],[object Object]
2.5. Validations ,[object Object],[object Object],[object Object]
2.6.  Stability Studies ,[object Object],[object Object],[object Object]
2.7. Data on Formulation ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Data on Formulation (Contd..) ,[object Object],[object Object],[object Object],[object Object],[object Object]
Data on Formulation (Contd..) ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
3.       Animal Pharmacology ,[object Object],[object Object],[object Object],[object Object],[object Object]
4.       Animal Toxicology ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
5.   Human / Clinical pharmacology (Phase I) ,[object Object],[object Object],[object Object],[object Object],[object Object]
6.       Therapeutic exploratory trials (Phase II) ,[object Object],[object Object]
7.       Therapeutic confirmatory trials (Phase III) ,[object Object],[object Object]
8.       Special studies ,[object Object],[object Object],[object Object],[object Object],[object Object]
9.       Regulatory status in other countries ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
10.   Prescribing information ,[object Object],[object Object]
11.   Samples and Testing Protocol/s ,[object Object]
APPENDIX I-A ,[object Object]
APPENDIX I-A ,[object Object],[object Object],[object Object],[object Object]
2. Chemical and pharmaceutical information ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
3. Marketing information ,[object Object],[object Object]
4. Special studies conducted with approval of Licensing Authority ,[object Object],[object Object]
Appendix II ,[object Object]
Appendix II ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Appendix II ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Appendix II ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Appendix II Appendices to Clinical trial report ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Appendix III ,[object Object],[object Object]
Appendix III ,[object Object],[object Object]
General Principles ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
1.1 Systemic Toxicity Studies ,[object Object],[object Object]
Single-dose Toxicity Studies ,[object Object],[object Object],[object Object],[object Object]
1.1.2    Repeated-dose Systemic Toxicity Studies ,[object Object],[object Object]
Repeated-dose Systemic Toxicity Studies ,[object Object],[object Object]
Repeated-dose Systemic Toxicity Studies ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
1.2    Male Fertility Study ,[object Object],[object Object],[object Object],[object Object],[object Object]
Male Fertility Study ,[object Object],[object Object],[object Object],[object Object],[object Object]
1.3     Female Reproduction and Developmental Toxicity Studies ,[object Object]
1.3.1 Female Fertility Study (Segment I): ,[object Object],[object Object],[object Object]
Female Fertility Study (Segment I): ,[object Object],[object Object],[object Object],[object Object]
Female Fertility Study (Segment I): ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Female Fertility Study (Segment I): ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
1.3.2     Teratogenicity Study (Segment II): ,[object Object],[object Object],[object Object]
Teratogenicity Study (Segment II): ,[object Object],[object Object],[object Object]
Teratogenicity Study (Segment II): ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
1.3.3     Perinatal Study (Segment III): ,[object Object],[object Object]
Perinatal Study (Segment III): ,[object Object],[object Object],[object Object]
Perinatal Study (Segment III): ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
1.4   Local toxicity ,[object Object],[object Object],[object Object]
Local toxicity ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
1.5   Allergenicity/ Hypersensitivity: ,[object Object],[object Object]
1.6        Genotoxicity ,[object Object],[object Object],[object Object]
1.7    Carcinogenicity ,[object Object],[object Object],[object Object]
1.8 Animal toxicity requirements for clinical trials and marketing of a new drug.
Route of administration Duration of proposed human administration Human Phase(s) for which study is proposed to be conducted Long term toxicity requirements Oral or Parenteral or Transdermal Single dose or several doses in one day, Upto 1wk I,II,III 2sp,2wk   > 1 wk but upto 2wk I,II,III 2sp;4wk   > 2 wk but upto 4wk I,II,III 2sp;12wk   Over 1mo I,II,III 2sp;24wk Inhalation (general anaesthetics, aerosols) Upto 2 wk I,II,III 2sp;1mo; (Exposure time 3h/d, 5d/wk)   Upto 4wk I,II,III 2sp;12wk, (Exposure time 6h/d, 5d/wk)   > 1 4wk I,II,III 2sp;24wk, (Exposure time 6h/d, 5d/wk)
Dermal Upto 2 wk I,II 1sp;4wk     III 2sp;4wk   > 2 wk I,II,III 2sp;12wk Ocular or Otic or Nasal Upto 2 wk I,II 1sp;4wk     III 2sp;4wk   > 2 wk I,II,III 2sp;12wk Vaginal or Rectal Upto 2 wk I,II 1sp;4wk     III 2sp;4wk   > 2 wk I,II,III 2sp;12wk
1.9 Number of animals required for repeated-dose toxicity studies   14-28 days 84-182 days Group Rodent (Rat) Non-rodent (Dog or Monkey) Rodent (Rat) Non-rodent (Dog or Monkey)   M F M F M F M F Control 6-10 6-10 2-3 2-3 15-30 15-30 4-6 4-6 Low dose 6-10 6-10 2-3 2-3 15-30 15-30 4-6 4-6 Intermediate dose 6-10 6-10 2-3 2-3 15-30 15-30 4-6 4-6 High dose 6-10 6-10 2-3 2-3 15-30 15-30 4-6 4-6
2.0 Laboratory parameters to be included in toxicity studies. ,[object Object],[object Object],[object Object],[object Object]
Haematological parameters Haemoglobin Total RBC Count Haematocrit Reticulocyte Total WBC Count Differential WBC Count Platelet Count Terminal Bone Marrow Examination ESR (Non-rodents only) General Blood Picture: A special mention of abnormal and immature cells should be made. Coagulation Parameters (Non-rodents only): Bleeding Time, Coagulation Time, Prothrombin Time, Activated Partial Thromboplastin Time
Urinalysis Parameters Colour Appearance Specific Gravity 24-hour urinary output Reaction (pH) Albumin Sugar Acetone Bile pigments Urobilinogen Occult Blood   Microscopic examination of urinary sediment.
Blood Biochemical Parameters Glucose Cholesterol Triglycerides HDL Cholesterol (Non-rodents only) LDL Cholesterol (Non-rodents only) Bilirubin SGPT (ALT) SGOT (AST) Alkaline Phosphatase (ALP) GGT (Non-rodents only) Blood Urea Nitrogen Creatinine Total Proteins Albumin Globulin (Calculated values) Sodium Potassium Phosphorus Calcium  
Gross and Microscopic Pathology Brain*: Cerebrum, cerebellum, Midbrain (Spinal Cord) Eye (Middle Ear) Thyroid (Parathyroid) Spleen* Thymus Adrenal* (Pancreas) (Trachea) Lung* Heart* Aorta Oesophagus Stomach Duodenum Jejunum Terminal ileum Colon (Rectum) Liver* Kidney* Urinary bladder Epididymis Testis* Ovary Uterus* Skin Mammary gland Mesenteric lymph node Skeletal muscle
For Phase I studies: ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
For Phase I studies: ,[object Object],[object Object],[object Object]
Phase II Clinical Trials ,[object Object],[object Object]
Phase II Clinical Trials ,[object Object],[object Object],[object Object]
Phase III Clinical Trials ,[object Object],[object Object],[object Object]
Phase III Clinical Trials ,[object Object],[object Object],[object Object],[object Object]
Phase IV Clinical Trials ,[object Object]
Application Of Good Laboratory Practices (GLP) ,[object Object],[object Object]
Appendix IV ,[object Object]
Appendix IV ,[object Object],[object Object],[object Object],Specific Pharmacological studies General Pharmacological studies
Appendix IV ,[object Object],[object Object],[object Object],[object Object],[object Object]
Appendix IV ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Appendix IV ,[object Object],1.2.1 Essential Safety Pharmacology 1.3 Follow up & supplemental safety pharmacological studies: ,[object Object],[object Object],[object Object],[object Object],[object Object]
Appendix IV ,[object Object],[object Object],[object Object]
Appendix V ,[object Object]
Appendix V ,[object Object],[object Object],[object Object],[object Object],[object Object]
Appendix V ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],1.1 Essential Elements of ICF
Appendix V ,[object Object],[object Object],[object Object],1.1 Essential Elements of ICF
Appendix V ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],1.1 Essential Elements of ICF
Appendix V ,[object Object],[object Object],[object Object],[object Object],[object Object],1.1 Essential Elements of ICF
Appendix V ,[object Object],[object Object],[object Object]
Appendix V ,[object Object],[object Object],1.2 Additional elements, which may be required
Appendix V ,[object Object],[object Object],1.2 Additional elements, which may be required
Format of ICF ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Appendix VI ,[object Object]
Appendix VI ,[object Object],[object Object],[object Object]
Appendix VI ,[object Object],[object Object],[object Object]
Appendix VI ,[object Object],[object Object],[object Object]
Appendix VI ,[object Object],[object Object],[object Object],[object Object],[object Object]
Appendix VI ,[object Object],[object Object],[object Object],[object Object]
Appendix VI ,[object Object],[object Object],[object Object],[object Object],[object Object]
Appendix VII ,[object Object]
Appendix VII ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Appendix VII ,[object Object],[object Object],[object Object],[object Object],[object Object]
Appendix VIII ,[object Object]
Appendix VIII ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Appendix VIII ,[object Object],[object Object],[object Object],[object Object],[object Object]
Appendix IX ,[object Object]
Appendix-IX ,[object Object],[object Object],[object Object],[object Object],[object Object]
Appendix-X ,[object Object]
Appendix-X ,[object Object],[object Object],[object Object],[object Object],[object Object]
Appendix-X Title Page contd ,[object Object],[object Object]
Appendix-X ,[object Object],[object Object],[object Object],[object Object],[object Object]
Appendix-X ,[object Object],[object Object],[object Object]
Appendix-X ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Appendix-X ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Appendix-X ,[object Object],[object Object],[object Object]
Appendix-X ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Appendix-X ,[object Object],[object Object],[object Object],[object Object]
Appendix-X ,[object Object],[object Object],[object Object]
Appendix-X ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Appendix-X ,[object Object],[object Object],[object Object],[object Object],[object Object]
Appendix-X ,[object Object],[object Object],[object Object],[object Object],[object Object]
Appendix-X ,[object Object],[object Object],[object Object],[object Object],[object Object]
Appendix-X ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Appendix-X ,[object Object],[object Object],[object Object],[object Object]
Appendix-X ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Appendix-X ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Appendix-X ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Appendix-XI ,[object Object]
Appendix-XI ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Appendix-XI ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Appendix-XI ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Appendix-XI ,[object Object],[object Object],[object Object],[object Object],[object Object]
Appendix-XI ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Appendix-XI ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
 
[object Object]
[object Object]
24 H 7 D 14 D 14 D
Loopholes in Schedule Y ,[object Object],[object Object],[object Object],[object Object]
Loopholes in schedule Y ,[object Object],[object Object],[object Object]
Unattended Areas ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Thank you

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Schedule Y Appendices Clinical Trial Data

  • 1. Schedule Y By: Kirtikrushna
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  • 60. 1.8 Animal toxicity requirements for clinical trials and marketing of a new drug.
  • 61. Route of administration Duration of proposed human administration Human Phase(s) for which study is proposed to be conducted Long term toxicity requirements Oral or Parenteral or Transdermal Single dose or several doses in one day, Upto 1wk I,II,III 2sp,2wk   > 1 wk but upto 2wk I,II,III 2sp;4wk   > 2 wk but upto 4wk I,II,III 2sp;12wk   Over 1mo I,II,III 2sp;24wk Inhalation (general anaesthetics, aerosols) Upto 2 wk I,II,III 2sp;1mo; (Exposure time 3h/d, 5d/wk)   Upto 4wk I,II,III 2sp;12wk, (Exposure time 6h/d, 5d/wk)   > 1 4wk I,II,III 2sp;24wk, (Exposure time 6h/d, 5d/wk)
  • 62. Dermal Upto 2 wk I,II 1sp;4wk     III 2sp;4wk   > 2 wk I,II,III 2sp;12wk Ocular or Otic or Nasal Upto 2 wk I,II 1sp;4wk     III 2sp;4wk   > 2 wk I,II,III 2sp;12wk Vaginal or Rectal Upto 2 wk I,II 1sp;4wk     III 2sp;4wk   > 2 wk I,II,III 2sp;12wk
  • 63. 1.9 Number of animals required for repeated-dose toxicity studies   14-28 days 84-182 days Group Rodent (Rat) Non-rodent (Dog or Monkey) Rodent (Rat) Non-rodent (Dog or Monkey)   M F M F M F M F Control 6-10 6-10 2-3 2-3 15-30 15-30 4-6 4-6 Low dose 6-10 6-10 2-3 2-3 15-30 15-30 4-6 4-6 Intermediate dose 6-10 6-10 2-3 2-3 15-30 15-30 4-6 4-6 High dose 6-10 6-10 2-3 2-3 15-30 15-30 4-6 4-6
  • 64.
  • 65. Haematological parameters Haemoglobin Total RBC Count Haematocrit Reticulocyte Total WBC Count Differential WBC Count Platelet Count Terminal Bone Marrow Examination ESR (Non-rodents only) General Blood Picture: A special mention of abnormal and immature cells should be made. Coagulation Parameters (Non-rodents only): Bleeding Time, Coagulation Time, Prothrombin Time, Activated Partial Thromboplastin Time
  • 66. Urinalysis Parameters Colour Appearance Specific Gravity 24-hour urinary output Reaction (pH) Albumin Sugar Acetone Bile pigments Urobilinogen Occult Blood   Microscopic examination of urinary sediment.
  • 67. Blood Biochemical Parameters Glucose Cholesterol Triglycerides HDL Cholesterol (Non-rodents only) LDL Cholesterol (Non-rodents only) Bilirubin SGPT (ALT) SGOT (AST) Alkaline Phosphatase (ALP) GGT (Non-rodents only) Blood Urea Nitrogen Creatinine Total Proteins Albumin Globulin (Calculated values) Sodium Potassium Phosphorus Calcium  
  • 68. Gross and Microscopic Pathology Brain*: Cerebrum, cerebellum, Midbrain (Spinal Cord) Eye (Middle Ear) Thyroid (Parathyroid) Spleen* Thymus Adrenal* (Pancreas) (Trachea) Lung* Heart* Aorta Oesophagus Stomach Duodenum Jejunum Terminal ileum Colon (Rectum) Liver* Kidney* Urinary bladder Epididymis Testis* Ovary Uterus* Skin Mammary gland Mesenteric lymph node Skeletal muscle
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  • 138. 24 H 7 D 14 D 14 D
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