Compilation of herbal plants (description, geographical distribution, taxonomy, line drawings), biodiversity and herbarium.
Description of herbal and T&CM research, searchable publication and process from medicinal plant discovery to clinical trial in producing a high-quality registered herbal drug.
Definition and description of therapies, policy, training and education, research in the practise of (T&CM) and integrated medicine system.
MALAYSIAN HERBAL MONOGRAPH 2015 is available now!!! For more details, click here
Type of studies |
Observation |
Timing of study |
Pharmacodynamic studies |
|
Herbal Drug Discovery |
|
Prior to first administration in human (Preclinical testing) |
|
Safety pharmacology |
Effect on core system of the body: Central Nervous System, Respiratory System, Cardiovascular System.
|
Prior to first administration in humans (Preclinical testing): Conducted on core system of the body
Any follow-up or supplemental studies identified as appropriate, based on a cause for concern
During Clinical Development: Additional studies may be warranted to clarify observed or suspected adverse effects in animals and humans
Before clinical trial and product registration: Supplemental studies (if warranted) |
Toxicokinetic studies |
The study is conducted to quantify exposure of:
|
Single-dose toxicity studies: Early phase of development
Repeated-dose toxicity studies: |
|
Related to the duration, therapeutic indication and scope of propose clinical trial
Genotoxicity studies: In vitro (Preclinical testing) In vivo (During clinical trials)
Reproductive studies: Before phase III
Carcinogenicity studies: Case- by- case |
|
General toxicity studies |
These studies are conducted to obtain values as below:
|
During Preclinical testing |
The study is conducted in two mammalian species using both clinical and parenteral route of administration, with the objective to determine the mode of death and a quantitative evaluation of the approximate lethal dose. |
Prior to first administration in humans (Preclinical testing) |
|
The study is conducted in two mammalian species (one non-rodent) to obtain toxicity profile:
|
Prior to first administration in humans (2 Weeks)
During clinical development Before phase II: 2W – 6M Before phase III: 1M - chronic
|
|
Genotoxicity studies |
|
Prior to first administration in humans ( Genotoxicity in vitro)
During Clinical Development (Genotoxicity in vivo) |
Carcinogenicity studies |
|
Expected clinical use is continous for at least 6 months |
|
||
Reproduction toxicity studies |
The data should be obtained are as below:
- Foetal survival - Body weight - External and visceral examination
|
Prior to phase III |
The data should be obtained are as below:
|
According to site/s in clinical use |
|
Immunotoxicity studies |
Case-by-case |
Case-by-case |
Photosafety testing |
Case-by-case |
Case-by-case |
1. International Conference on Harmonisation (ICH) Tripartite Guideline. Preclinical Safety Evaluation of Biotechnology – Derived Pharmaceuticals S6 (R1). 12 June 2011.
Consumer data including medicinal herbs, dietary supplement monographs, health condition monographs and interactions and depletions.
Read MoreProfessional data organized into medicinal herbs, dietary supplement monographs, health condition monographs, T&CM herbs, formulas, health conditions, interactions and depletions.
Read MoreWe offer International linkages to provide extensive content pertaining to many facets of T&CM as well as Integrated Medicine. Please register for access.
Read More