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Conduct Safety Studies for Pharmaceuticals

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Prof. Dr. Basavaraj Nanjwade
Prof. Dr. Basavaraj Nanjwade
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Design and Conduct Safety Pharmacology & Toxicology Study for Pharmaceuticals Dr. Basavaraj K. Nanjwade M.Pharm., Ph.D Professor of Pharmaceutics Department of Pharmaceutics, KLE University, BELGAUM – 590010, Karnataka, India E-mail: [email_address] Cell No: +919742431000
R & D Pharmacology and Toxicology ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],HISTOPATHOLOGICAL AND BIOCHEMISTRY STUDIES 30/12/2009 Nepal Research Foundation., Birgunj, Nepal.
[object Object],30/12/2009 Nepal Research Foundation., Birgunj, Nepal.
Oncology ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],30/12/2009 Nepal Research Foundation., Birgunj, Nepal.
Oncology ,[object Object],[object Object],[object Object],[object Object],30/12/2009 Nepal Research Foundation., Birgunj, Nepal.
Pain and Inflammation ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],30/12/2009 Nepal Research Foundation., Birgunj, Nepal.
Pain and Inflammation ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],30/12/2009 Nepal Research Foundation., Birgunj, Nepal.
Pain and Inflammation ,[object Object],[object Object],[object Object],30/12/2009 Nepal Research Foundation., Birgunj, Nepal.
Metabolic Disorder ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],30/12/2009 Nepal Research Foundation., Birgunj, Nepal.
Respiratory Diseases ,[object Object],[object Object],[object Object],[object Object],[object Object],30/12/2009 Nepal Research Foundation., Birgunj, Nepal.
Psychopharmacology Models ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],30/12/2009 Nepal Research Foundation., Birgunj, Nepal.
[object Object],30/12/2009 Nepal Research Foundation., Birgunj, Nepal.
General Toxicology ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],30/12/2009 Nepal Research Foundation., Birgunj, Nepal.
In-Vivo Genotoxicity Studies ,[object Object],[object Object],[object Object],30/12/2009 Nepal Research Foundation., Birgunj, Nepal.
Development & Reproduction toxicology ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],30/12/2009 Nepal Research Foundation., Birgunj, Nepal.
Special Toxicity Studies ,[object Object],[object Object],[object Object],30/12/2009 Nepal Research Foundation., Birgunj, Nepal.
[object Object],30/12/2009 Nepal Research Foundation., Birgunj, Nepal.
In – Vitro Toxicology ,[object Object],[object Object],[object Object],30/12/2009 Nepal Research Foundation., Birgunj, Nepal.
In-Vitro Genotoxicity Studies ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],30/12/2009 Nepal Research Foundation., Birgunj, Nepal.
[object Object],30/12/2009 Nepal Research Foundation., Birgunj, Nepal.
Scope and Principle ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],29/12/2009 Nepal Pharmaceuticals Ltd., Birgunj, Nepal. 30/12/2009 Nepal Research Foundation., Birgunj, Nepal.
Definition of Safety Pharmacology ,[object Object],[object Object],[object Object],[object Object],30/12/2009 Nepal Research Foundation., Birgunj, Nepal.
Objectives of Studies ,[object Object],[object Object],[object Object],30/12/2009 Nepal Research Foundation., Birgunj, Nepal.
General Considerations in Selection and Design of Safety Pharmacology ,[object Object],[object Object],30/12/2009 Nepal Research Foundation., Birgunj, Nepal.
General Considerations in Selection and Design of Safety Pharmacology ,[object Object],[object Object],30/12/2009 Nepal Research Foundation., Birgunj, Nepal.
Test Systems ,[object Object],[object Object],[object Object],[object Object],[object Object],30/12/2009 Nepal Research Foundation., Birgunj, Nepal.
General Considerations on Test Systems ,[object Object],[object Object],30/12/2009 Nepal Research Foundation., Birgunj, Nepal.
Use of In Vivo and in Vitro Studies ,[object Object],[object Object],[object Object],[object Object],30/12/2009 Nepal Research Foundation., Birgunj, Nepal.
Sample Size and Use of Controls ,[object Object],[object Object],[object Object],[object Object],30/12/2009 Nepal Research Foundation., Birgunj, Nepal.
Route of Administration ,[object Object],[object Object],[object Object],30/12/2009 Nepal Research Foundation., Birgunj, Nepal.
Dose Levels or Concentrations of test Substance ,[object Object],[object Object],30/12/2009 Nepal Research Foundation., Birgunj, Nepal.
In Vivo Studies ,[object Object],[object Object],[object Object],30/12/2009 Nepal Research Foundation., Birgunj, Nepal.
In Vitro Studies ,[object Object],[object Object],[object Object],[object Object],30/12/2009 Nepal Research Foundation., Birgunj, Nepal.
Duration of Studies ,[object Object],[object Object],30/12/2009 Nepal Research Foundation., Birgunj, Nepal.
Studies on Metabolites, Isomers and Finished Products ,[object Object],[object Object],30/12/2009 Nepal Research Foundation., Birgunj, Nepal.
Studies on Metabolites, Isomers and Finished Products ,[object Object],[object Object],30/12/2009 Nepal Research Foundation., Birgunj, Nepal.
Safety Pharmacology Core Battery ,[object Object],[object Object],[object Object],30/12/2009 Nepal Research Foundation., Birgunj, Nepal.
Central Nervous System ,[object Object],[object Object],30/12/2009 Nepal Research Foundation., Birgunj, Nepal.
Cardiovascular System ,[object Object],[object Object],[object Object],30/12/2009 Nepal Research Foundation., Birgunj, Nepal.
Respiratory System ,[object Object],[object Object],[object Object],30/12/2009 Nepal Research Foundation., Birgunj, Nepal.
Follow-up and Supplemental Safety Pharmacology Studies ,[object Object],[object Object],[object Object],[object Object],30/12/2009 Nepal Research Foundation., Birgunj, Nepal.
Central Nervous System, Cardiovascular System & Respiratory System ,[object Object],[object Object],[object Object],30/12/2009 Nepal Research Foundation., Birgunj, Nepal.
Follow-up and Supplemental Safety Pharmacology Studies ,[object Object],[object Object],[object Object],[object Object],[object Object],30/12/2009 Nepal Research Foundation., Birgunj, Nepal.
Renal/Urinary System ,[object Object],[object Object],[object Object],30/12/2009 Nepal Research Foundation., Birgunj, Nepal.
Autonomic Nervous System ,[object Object],[object Object],[object Object],30/12/2009 Nepal Research Foundation., Birgunj, Nepal.
Gastrointestinal System ,[object Object],[object Object],[object Object],30/12/2009 Nepal Research Foundation., Birgunj, Nepal.
Other Organ Systems ,[object Object],[object Object],[object Object],30/12/2009 Nepal Research Foundation., Birgunj, Nepal.
Conditions Under Which Studies are Not Necessary ,[object Object],[object Object],[object Object],[object Object],[object Object],30/12/2009 Nepal Research Foundation., Birgunj, Nepal.
Timing of Safety Pharmacology Studies in Relation to Clinical Development ,[object Object],[object Object],[object Object],30/12/2009 Nepal Research Foundation., Birgunj, Nepal.
Studies prior to First Administration in Human ,[object Object],[object Object],[object Object],30/12/2009 Nepal Research Foundation., Birgunj, Nepal.
Studies During Clinical Development ,[object Object],30/12/2009 Nepal Research Foundation., Birgunj, Nepal.
Studies Before Approval ,[object Object],[object Object],30/12/2009 Nepal Research Foundation., Birgunj, Nepal.
Application of Good Laboratory Practice (GLP) ,[object Object],[object Object],[object Object],30/12/2009 Nepal Research Foundation., Birgunj, Nepal.
Application of Good Laboratory Practice (GLP) ,[object Object],[object Object],[object Object],30/12/2009 Nepal Research Foundation., Birgunj, Nepal.
Application of Good Laboratory Practice (GLP) ,[object Object],[object Object],30/12/2009 Nepal Research Foundation., Birgunj, Nepal.
[object Object],30/12/2009 Nepal Research Foundation., Birgunj, Nepal.
In-vivo DMPK Studies ,[object Object],[object Object],[object Object],[object Object],[object Object],30/12/2009 Nepal Research Foundation., Birgunj, Nepal.
In-vitro DMPK Studies ,[object Object],[object Object],[object Object],[object Object],30/12/2009 Nepal Research Foundation., Birgunj, Nepal.
Plasma Protein Binding ,[object Object],[object Object],[object Object],30/12/2009 Nepal Research Foundation., Birgunj, Nepal.
Drug –Drug Interaction Studies ,[object Object],[object Object],30/12/2009 Nepal Research Foundation., Birgunj, Nepal.
Special Analytical Studies ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],30/12/2009 Nepal Research Foundation., Birgunj, Nepal.
[object Object],30/12/2009 Nepal Research Foundation., Birgunj, Nepal.
Hematology ,[object Object],[object Object],[object Object],[object Object],30/12/2009 Nepal Research Foundation., Birgunj, Nepal.
Clinical Chemistry ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],30/12/2009 Nepal Research Foundation., Birgunj, Nepal.
Biomarkers ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],30/12/2009 Nepal Research Foundation., Birgunj, Nepal.
[object Object],30/12/2009 Nepal Research Foundation., Birgunj, Nepal.
General Pharmacology Equipments ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],30/12/2009 Nepal Research Foundation., Birgunj, Nepal.
General Pharmacology Equipments ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],30/12/2009 Nepal Research Foundation., Birgunj, Nepal.
List of Critical Equipment for Pharmacology ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],30/12/2009 Nepal Research Foundation., Birgunj, Nepal.
List of Critical Equipments for ADME and PK ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],30/12/2009 Nepal Research Foundation., Birgunj, Nepal.
List of Critical Equipment for Assay Development ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],30/12/2009 Nepal Research Foundation., Birgunj, Nepal.
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],List of Critical Equipment for Assay Development 30/12/2009 Nepal Research Foundation., Birgunj, Nepal.
List of Critical Equipments for Molecular Biology and Gene Expression ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],30/12/2009 Nepal Research Foundation., Birgunj, Nepal.
List of Critical Equipments for Molecular Biology and Gene Expression ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],30/12/2009 Nepal Research Foundation., Birgunj, Nepal.
PHARMACOLOGY LAB LAY OUT (ANIMAL HOUSE) Entrance Sterile room for exchange of clothes, belongings etc Restricted Entry HOD’s Office Discussion/Meeting Room Library Senior and Junior Research Officers Well equipped Sample’s Analysis Room Restricted Entrance Quarantine room Dosing Room Animal House for MICE Animal house for RATS Operation Room for invasive procedures Animal House for Rabbits Animal House for Guinea Pigs Dosing Room Mating Room for Rats and Mice 30/12/2009 Nepal Research Foundation., Birgunj, Nepal.
Rodent Facility ,[object Object],[object Object],30/12/2009 Nepal Research Foundation., Birgunj, Nepal.
International Guidelines ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],30/12/2009 Nepal Research Foundation., Birgunj, Nepal.
Thanking You 30/12/2009 Nepal Research Foundation., Birgunj, Nepal.

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Conduct Safety Studies for Pharmaceuticals

  • 1. Design and Conduct Safety Pharmacology & Toxicology Study for Pharmaceuticals Dr. Basavaraj K. Nanjwade M.Pharm., Ph.D Professor of Pharmaceutics Department of Pharmaceutics, KLE University, BELGAUM – 590010, Karnataka, India E-mail: [email_address] Cell No: +919742431000
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  • 75. PHARMACOLOGY LAB LAY OUT (ANIMAL HOUSE) Entrance Sterile room for exchange of clothes, belongings etc Restricted Entry HOD’s Office Discussion/Meeting Room Library Senior and Junior Research Officers Well equipped Sample’s Analysis Room Restricted Entrance Quarantine room Dosing Room Animal House for MICE Animal house for RATS Operation Room for invasive procedures Animal House for Rabbits Animal House for Guinea Pigs Dosing Room Mating Room for Rats and Mice 30/12/2009 Nepal Research Foundation., Birgunj, Nepal.
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  • 78. Thanking You 30/12/2009 Nepal Research Foundation., Birgunj, Nepal.