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Assisting Domestic Pharmaceutical
Industry
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| Improvements
in Manufacturing Technology |
Modified Film Coating Manufacturing Technology
Controlled Release Dosage Forms Technology
Dissolution Test Evaluation
BA/BE Evaluation for Domestic Products
Chinese and Western Medicine Analytical Methodologies
Chinese and Western Medicine Manufacturing Process
Technology
Verification of cGMP Status of Pharmaceutical Companies
GMP of Chinese Medicine Factories |
| Promote
Scientifically-Tested Modern Chinese Medicine |
Development of QC Technology for Chinese Herbs and
Herbal Preparations
Upgrade Chinese Herbal Products Manufacturing Process
Technology
Preparation and Supply of Chemical Markers for Chinese
Herbs |
| Development
of New Pharmaceutical Technology |
Development of Water-based Patches
Development of Controlled Release Dosage Forms
Technology for Semi-solid Dosage Forms
New Technology for Rapidly Dissolving Oral Drug
Dosage Forms
Micro-Analytical Techniques for Blood Samples and
Simultaneous Analytical Techniques for Multiple
Drugs |
| Pharmaceutical
industry personnel training |
Completed training of over 10,000 domestic industry
personnel |
| Promotion
of overseas marketing of domestic pharmaceuticals |
China ¡V Australia reciprocal GMP accreditation
Guidance in marketing of drugs to advanced countries |
| Validation
for pharmaceutical factories |
completed training of 500 industry personnel |
Assistance
in the improvement of manufacture and QC
technology of veterinary drugs |
Factory inspection and re-inspection of veterinary
drugs GMP
Education and training of factory inspectors
Gathering of local human drug cGMP articles, as
well as Mainland China, USA and Japan veterinary
drug articles |
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Assisting in the Promotion
of Pharmaceutical Policies in Taiwan
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| The
promotion of the sterilization process validation |
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Sterilization
process validation guideline |
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Training and
educational programs for seeding faculty |
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Educational and
consultation services for companies |
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carrying out
efficacy validation, calibration verification |
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of
sterilization equipment, temperature calibration
verification |
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| Activities
to promote medicinal stability testing |
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Setting up educational
programs on medicinal stability |
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testing
standards |
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| The
promotion of the current GMP -Total Validation |
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Establishing
operational standards for GMP validation |
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Producing validation
instruction handbooks
¡§Analytical Method Validation Guideline¡¨,
¡§Cleaning Validation Guideline¡¨,
¡§Water System Validation Guideline¡¨,
¡§Process Validation Guideline¡¨,
¡§Air Conditioning System Validation Guideline¡¨
and English translations of the guideline
validation for
analytical method, cleaning, water system,
and process |
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Conducting educational
and training programs for factory inspectors |
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| Guidance
for the change of pharmaceutical product formulas |
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The
recommendation draft for Taiwan regarding
to the Scale-up and post approval change guidance
for Immediate Release Solid Oral dosage forms |
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The
comparison of the regulatory requirement regarding
to the Scale-up and post approval change of
modified release dosage forms |
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Survey
on post approval changes of pharmaceutical
products in Taiwan |
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Survey
on the impact on the formulation and manufacturing
process due to manufacturing site change |
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Compiling
the related regulations from various countries
on bio-equivalency dissolution profiles comparison
and pharmaceutical excipients |
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The
regulatory requirement on the Scale-up and
post approval changes for modified and semisolid
dosage forms. |
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Auditing
of plant master file information from import
pharmaceutical |
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Revision of Guidelines
and checklist for plant master file
preparation |
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| Examination
of OTC pharmaceutical products |
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Revising of monographs
for products of vitamins and over the counter
drugs including ophthalmic, general cold,
gastrointestinal, and antihistamine preparations |
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Developing Technology that
is Cutting-edge, Critically Important and Universally
Applied
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Strategic
development plan for Taiwan¡¦s Chinese herbal
medicine industry |
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Surveying development
trends in herbal medicine sales
regulations, patents and market conditions
in the EU, USA,
Japan and China |
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Surveying local
Chinese herbal medicine industry, government
and academic research resources |
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Designing
in vitro and in vivo pharmacological screening
models for Chinese herbal medicines with development
potential |
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Drafting
examination criteria for Chinese herbal medicine
patents in Taiwan |
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Reporting
on the strategic development of Taiwan's
Chinese herbal medicine industry |
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| Developing
New Chinese Herbal Medicines |
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Pre-clinical
research platform technology for Chinese herbal
anti-gastric ulcer medicine (we have already
received permission from FDA Investigational
New Drug to conduct clinical testing).
- Extracting Technology for curative effects
- Atlas of Bioactivity and Chemical Fingerprint
- Chemistry, Manufacture and Control (CMC)
Technology |
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| Quality
control and analytical technique for Chinese herbs |
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Establishment
the specification of Chinese herbs and collection
standard herbs |
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Taxonomy
identification of standard herbs |
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Establishing
the HPLC fingerprint technology for 10 Chinese
herbs |
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Purification
and supply of chemical markers in Chinese
herbs |
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Establishing
the platform technology for examining heavy
metals in Chinese herbs |
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Establishing
the pre-treatment technology for the detection
of pesticide and heavy metals |
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Collection of
the processing methods for Chinese herbs from
domestic and foreign countries |
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| Developing
Technologies for new TCM dosage forms |
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New dosage forms
for water-based anti-inflammation and pain-relief
patch of Chinese herbs.
- Extraction and manufacturing technology
- Base formula technology for water-based
patch
- HPLC analytical technology for the Jin Si
Gau water-
¡@based patch
- Dosage form technology for the Jin Si Gau
water-based
¡@patch |
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Chinese herbal
ointment for burns
- Optimizing extraction technology for Zi
Yun Gau
- Standardized technology for mass production
- HPLC synchronized analytical technology
for multiple
¡@ingredients in Zi Yun Gau
- Evaluation and testing technology for efficacy
of
¡@treatment on burns |
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Chinese medicinal
diaphoretics and ointments
- Formula for Yin Qiao San ointment
- 500-day mass production manufacturing technology
and ¡@¡@
¡@standardization
- HPLC synchronized analysis technology for
multiple
¡@ingredients |
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Dissolvable antihypertensive
granule preparation of Chinese herbs
- Drinkable formula for Tian Ma Gou Teng YINN
- HPLC synchronized analysis technology for
multiple
¡@active ingredients
- Development of 500-day mass production manufacturing
¡@technology |
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| Technology
development for New Dosage Forms in Western Medicine |
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Develop an oral
mucosal medicine delivery system (OMDDS)
- Formula of OMDDS tabs
- Formula of OMDDS patch
- Create a diffusion testing and evaluation
technology for oral ¡@
¡@mucosal medicine delivery systems for rodent
and non-rodent
¡@mammals
- Technology to test and evaluate safety
- Methodologies for formulating, producing,
and analyzing
¡@vitamin B2 OMDDS tablets and dissolving testing
technology ¡@evaluation
- Methodologies for formulating, producing,
and analyzing
¡@vitamin B2 OMDDS patch and dissolving testing
technology ¡@evaluation |
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Formula for Triamcinolone
Acetonide (TA) OMDDS tablets
- Pre-formulation/Formulation / Production
- Analytical Technology
- Evaluation medicine released in vitro/ performance
of
Bio-adhesive agent |
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Dosage form technology
for testosterone OMDDS controlled-release
tablets
- Pre-formulation/Formulation / Production
- Analytical technology |
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Solid coating
engineering technology
- Development of mass production engineering
technology for ¡@10kg Omeprazole coated enteric
capsules
- Dosage form technology for the production
of Omeprazole
¡@20mg oil coated, powder-filled, enteric capsules
- Filling and sealing technology for Omeprazole,
oil-filled
¡@capsules
- Development of formula and engineering technology
for
¡@enteric-coating film of Omeprazole capsules |
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Design of platform
technology to screen pharmacological
activity in Chinese herbal medicine
- Effects on calmness, prostate hypertrophy,
digestive ulcers,
¡@cough suppressing, anti-inflammation, anti-depression,
¡@anti-anxiety, rheumatoid arthritis and sexual
function |
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Medical
and Pharmaceutical
Industry Technology and Development Center
7F, No 9,
Wuquan
Rd., Wugu Township, Taipei County 248, Taiwan, R.O.C
Tel:886-2-6625-1166
Fax:886-2-6625-1177
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