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REGULATORY GUIDELINES FOR PRECLINICAL AND CLINICAL VALIDATION OF TRADITIONAL MEDICINES. BY. Dr. Basavaraj K. Nanjawade Associate Professor of Pharmaceutics Department of Pharmacology JN Medical College Belgaum-10 e-mail: bknanjwade@yahoo.co.in. Traditional Medicine.

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regulatory guidelines for preclinical and clinical validation of traditional medicines

REGULATORY GUIDELINES FOR PRECLINICAL AND CLINICAL VALIDATION OF TRADITIONAL MEDICINES

BY

Dr. Basavaraj K. Nanjawade

Associate Professor of Pharmaceutics

Department of Pharmacology

JN Medical College

Belgaum-10

e-mail: bknanjwade@yahoo.co.in

KLE University, Belgaum, India

traditional medicine
Traditional Medicine

“Traditional medicine refers to health practices, approaches, knowledge and beliefs incorporating plant, animal and mineral based medicines, spiritual therapies, manual techniques and exercises, applied singularly or in combination to treat, diagnose and prevent illnesses or maintain well-being”

KLE University, Belgaum, India

traditional medicine cam
Traditional Medicine/CAM
  • Non-Industrialized countries population uses for primary health care needs.

E.g. Africa up to 80%

  • In industrialized countries, adaptations of traditional medicine are “Complementary” or “Alternative” medicine

E.g. USA, EU, Australia etc.

KLE University, Belgaum, India

use and popularity of tm cam
Use and Popularity of TM/CAM
  • 30%-50% of the total medicinal consumption - China.
  • 60% first line treatment - Ghana, Nigeria and Zambia
  • Over 50% of the population have used CAM at least once – Europe & North America
  • 75% of people living with HIV/AIDS use TM/CAM - San Francisco, London & South Africa.

KLE University, Belgaum, India

use and popularity of tm cam5
Use and Popularity of TM/CAM
  • 158 million of the adult population use complementary medicines – US
  • US $ 17 billion was spent on traditional remedies in 2000
  • In UK annual expenditure on alternation medicine is US $ 230 million
  • The global market for herbal medicines currently stands at over US $ 60 billion annual and is growing steadily

KLE University, Belgaum, India

tcm products
TCM Products
  • Traditional Chinese Medicine products are taken to mean “finished TCM products and proprietary products”
  • A finished product is one that has undergone all stages of production, including packaging in its final containers and labeling.
  • A single TCM formula or product may contain between six to twenty different ingredients

KLE University, Belgaum, India

tcm products7
TCM Products
  • Chines medicinal materials showed that 86.8%, 12.5% and 0.7% of the products examined could be classified as herb, animal and mineral, respectively.

KLE University, Belgaum, India

natural products platform
"Natural Products" platform

KLE University, Belgaum, India

pre clinical studies
Pre-clinical studies
  • Pre-clinical studies serve a vital role in the drug discovery and development processes.
  • These studies can be used to identify lead compounds likely to possess favourable biopharmaceutic and pharmacokinetic properties in humans.
  • In addition, they can facilitate transition through the discovery - development interface and decrease the need for expensive and time-consuming clinical studies.

KLE University, Belgaum, India

pre clinical studies include
Pre-clinical studies include

-in vivo animal models- isolated perfused liver, kidney,intestine,

hind limb and heart- animal and human liver microsomes

- bioavailability studies- pharmacokinetic studies- prediction of oral absorption in humans- determination of mechanisms of intestinal

absorption

KLE University, Belgaum, India

pre clinical studies include11
Pre-clinical studies include

- assessment of transport, distribution and

elimination of compounds- validated models for cytochrome P450

enzymes- metabolism studies in human liver

microsomes- assessment of potential for metabolic drug –

drug interactions- analysis of drugs and metabolites in

biological matrices 

KLE University, Belgaum, India

limitations of preclinical studies
Limitations of preclinical studies

1.Suitable pharmacological models have not

yet been developed for many common

diseases

2.Toxicity testing is time-consuming &

expensive.

3. Large numbers of animals must be used.

4. Extrapolation of toxicity data from animals to

humans is not completely reliable.

5. Rare adverse effects are unlikely to be detected

KLE University, Belgaum, India

clinical studies include
Clinical studies include

Two types of clinical research

1. Methodology/study design

2. Clinical trials

a. Phase one study

b. Phase two study

c. Phase three study

d. Phase four study/Late Phase three-Post

Marketing

KLE University, Belgaum, India

slide15

INFORMATION TO BE PROVIDED IN AN IND FOR A BOTANICAL DRUG

IND

for a Botanical

Drug Product

General principles;

format and contents

(slid No. 16)

Initial clinical trial of a marketed

botanical product with no

known safety issues (Slid No. 17)

Initial clinical trial of a nonmarketed botanical

product or marketed botanical product with

known safety issues (Slid No. 19)

Expanded clinical Trial of any

botanical product (Slid No. 22)

Documentation of use limited CMC

information; previous human

experience may be sufficient

to support safety

More documentation of use and

more CMC information (Slid No. 17)

Same documentation of use but more

detailed CMC information; standard

nonclinical toxicology

studies may be needed (Slid 19)

Is the

product a

traditional

preparation?

No

Yes

If the product is marketed only

outside the U.S. additional CMC

and nonclinical safety information

may be needed (Slid. No. 17)

Previous human experience may be

sufficient to support safety (Slid. No 19)

Additional nonclinical safety

information may be needed (Slid No. 19)

KLE University, Belgaum, India

general principal format and contents
General principal & format and contents

A.IND information for different categories of botanicals

B. Basic format for INDs

1. Cover sheet

2.Table of contents

3. Introductory statement and general investigational plan

4. Investigators Brochure

5. Protocol

6.Chemistry, Manufacturing and Controls

7. Pharmacology and Toxicological Information

8. Previous Human Experience with the Product

KLE University, Belgaum, India

initial clinical trial of a marketed botanical product with no known safety issues
Initial clinical trial of a marketed botanical product with no known safety issues

A.Description of Product and Documentation of Human Use

  • Description of Botanicals Used
  • Currently Marketed Use

B. Chemistry, Manufacturing, and Controls

  • Botanical Raw Material
  • Botanical Drug Substance
  • Botanical Drug Product

a. Quantitative description

b. The composition or quantitative description manufacturer's

certificate of analysis

4. Placebo

5. Labeling

6. Environmental Assessment or Claim of Categorical Exclusion

KLE University, Belgaum, India

initial clinical trial of a marketed botanical product with no known safety issues18
Initial clinical trial of a marketed botanical product with no known safety issues

C. Pharmacology

  • All Marketed Botanical Products
  • Foreign- Marketed Botanical Products

D. Bioavailability

E. Clinical Considerations

KLE University, Belgaum, India

slide19
Initial clinical trial of a nonmarketed botanical product or marketed botanical product with known safety issues

A. Description of Product & Documentation of Human Use

1. Description of Botanicals Used

2. History of Use

3. Current Investigational Use

B. Chemistry, Manufacturing, & Controls

  • Botanical Raw Material
  • Botanical Drug Substance
  • A Quantitative
  • The quantitative description (strength)
  • Manufacturer (Processor)
  • Manufacturing process
  • Quality control tests

KLE University, Belgaum, India

slide20
Initial clinical trial of a nonmarketed botanical product or marketed botanical product with known safety issues

f. Container

g. Container label

3. Botanical Drug Product

  • Qualitative description
  • Composition, or quantitative description
  • Manufacturer
  • Manufacturing process
  • Quality control test
  • Container/Closure
  • Stability data on the drug product

4. Placebo

5. Labeling

KLE University, Belgaum, India

slide21
Initial clinical trial of a nonmarketed botanical product or marketed botanical product with known safety issues

6. Environmental Assessment or Claim of Categorical Exclusion

C. Preclinical Safety Assessment

  • Traditional Preparations
  • Others

D. Bioavailability

E. Clinical Considerations

KLE University, Belgaum, India

expanded clinical trial of any botanical product
Expanded clinical Trial of any botanical product
  • Description of Product & Documentation of Human Experience
  • Chemistry, Manufacturing, & Controls
  • Botanical raw material
  • Botanical drug substance
  • Qualitative identification
  • Chemical identification
  • Specifications
  • Manufacturing process
  • Quality control tests
  • Test methods
  • Reference standards
  • Containers & closure

KLE University, Belgaum, India

expanded clinical trial of any botanical product23
Expanded clinical Trial of any botanical product
  • Stability data
  • Container label

C. Botanical drug product

  • Qualitative description & the composition
  • Acceptance specifications
  • Manufacturing process
  • Quality control tests
  • Test methods
  • Containers & closure
  • Stability data

d. Placebo

e. Labeling

f. Claim of categorical exclusion

KLE University, Belgaum, India

expanded clinical trial of any botanical product24
Expanded clinical Trial of any botanical product

2. End-of-Phase 3 Clinical Studies & Pre-NDA Considerations

  • Botanical raw materials
  • Manufacturing process
  • Batch-to-batch consistency
  • Specifications
  • Analytical methods & test procedures
  • Reference standard
  • Stability-indicating analytical
  • Comparison of the similarities and/or differences in CMC among preclinical and clinical
  • Manufacturing and testing facilities
  • Claim for categorical exclusion

KLE University, Belgaum, India

expanded clinical trial of any botanical product25
Expanded clinical Trial of any botanical product

C. Preclinical Safety Assessment (including Pre-NDA)

  • Repeat-Dose General Toxicity Studies
  • Non-clinical Pharmacokinetic/Toxic-kinetic Studies
  • Reproductive Toxicology
  • Genotoxicity Studies
  • Carcinogenicity Studies
  • Special Pharmacology/Toxicology Studies
  • Regulatory Considerations

D. Bio-availability & Drug-Drug Interactions

E. Clinical Considerations

KLE University, Belgaum, India

slide26

The New Drug Development Process

KLE University, Belgaum, India

traditional ind
Traditional IND

KLE University, Belgaum, India

slide34

Conclusions of Exploratory IND

KLE University, Belgaum, India

slide35

Conclusions of Exploratory IND

KLE University, Belgaum, India

nda process
NDA Process

KLE University, Belgaum, India

generic drug anda process
Generic Drug (ANDA)Process

KLE University, Belgaum, India

otc drug monograph process
OTC Drug Monograph Process

KLE University, Belgaum, India

slide39

THANK YOU.....

e-mail: bknanjwade@yahoo.co.in

KLE University, Belgaum, India