Research Guidline safety & efficacy of herbal drug.pptx

The Research guidelines for evaluating the safety and efficacy of herbal medicines are intended to facilitate the work of research scientists and clinicians in this field and to furnish some reference points for the governmental, industrial and non-profit organizations that provide financial support for their work.
It must be emphasized that these guidelines are offered as a summary of scientific standards governing various aspects of the study of herbal medicines.

1. Quality Control & Standardization Of Herbals Research Guideline For Evaluating The Safety & Efficacy Of Herbal Medicines By Kaushal Kumar

2. Tabel Of Contents 01 02 03 04 Introduction Guidelines Research Guideline Scientific Guideline

3. The Research guidelines for evaluating the safety and efficacy of herbal medicines are intended to facilitate the work of research scientists and clinicians in this field and to furnish some reference points for the governmental, industrial and non-profit organizations that provide financial support for their work. It must be emphasized that these guidelines are offered as a summary of scientific standards governing various aspects of the study of herbal medicines. As such, they may be useful to the regulatory authorities who control the sale of these products and the governmental agencies and medical authorities who supervise their use in the health care system . Introduction

4. Research Guidelines The Research guidelines for evaluating the safety and efficacy of herbal medicines Guidelines for quality specifications of plant materials and preparations. Guidelines for pharmacodynamics and general pharmacological studies of herbal medicines. Guidelines for toxicity investigation of herbal medicines.

5. Scientific Guidelines ► Guidelines for quality specifications of plant materials and preparations ☺Information for Fresh, Dried and Processed Plant Materials → Name and characteristics → Quality specifications ⭧ Authenticity ⭧ Purity ⭧ Assay ⭧ Packaging, labelling and storage ☺Information for medicinal preparations of plant materials →Name and formula of the product → Quality specifications ○ Authenticity ○ Purity ○Assay ○ Packaging, labelling and storage

6. Scientific Guidelines ► Guidelines for Pharmacodynamics and General Pharmacological Studies of Herbal Medicines - Animals ⭧ Species ⭧ Disease Model Administration ⭧ Route Of Administration ⭧ Frequency ⭧ Control Group

7. Scientific Guidelines ► Guidelines for toxicity investigation of herbal medicines ☺ Acute Toxicity Test ○Animal Species ○Sex ○No. of Animals ○Rout of Administration ○Dose Level ○Frequency ○Observation ☺ Long Term Toxicity test ○Animal Species ○Sex ○No. of Animals ○Rout of Administration ○Dose Level ○Frequency ○Observation

8. Scientific Guidelines Observation & Examination → General signs, body weight, and food and water intake ⭧ Body Weight ⭧ Food Intake → Haematological examination → Renal and hepatic function tests → Other Function test

9. Scientific Guidelines Local Toxicity Test ◙ Skin sensitization test (Solid, Semi-Solid, Liquid) ◙ Experimental animal Adjuvant & Patch test Buehler test Draize test Maximization test Open epicutaneous test Optimization test Split Adjuvant test Freund’s complete adjuvant test ◙ Evaluation if test result ◙ Other local toxicity test

10. Scientific Guidelines ► Special Toxicity Test Mutagenic Test → Reverse Mutation Test in Bacteria ☺ Strain ☺Dose level ☺Control Group ☺Metabolic Activation → Chromosomal Aberration Test with Mammalian Cells in Culture ☻Cell ☻Dose level ☻ Control Group ☻ Metabolic Activation → Micronucleus Test with Rodents ◙ Animal ◙ No. of Animal ◙ ROA ◙ Dose Level ◙ Control Group

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