qps toxicology and preclinical services
DESCRIPTION
GENERAL TOXICOLOGY QPS offers a complete range of standard toxicology protocols designed for supporting submissions to international regulatory agencies. With multiple test species available (including nonhuman primates), studies are overseen by Study Directors with vast experience gained from performing over 1000 GLP studies for local and international pharmaceutical and biotechnology companies within many different disease therapies in the past 12 years, thereby ensuring quality performance, delivery of high quality data as well as proper interpretation, review and reporting of every aspect of your study. REPRODUCTIVE TOXICOLOGY QPS has been performing developmental and reproductive toxicity studies for pharmaceutical and biotechnology products for over 12 years. Using internationally recognized guidelines, including International Conference of Harmonization (ICH), we offer overall developmental and reproductive toxicology program planning and individual study design to conduct safety assessments for your pharmaceutical and biotechnology products. CLINICAL PATHOLOGY QPS's experienced Clinical Pathology Group offers a complete range of laboratory testing services. Our laboratories are equipped to provide the highest level of support to your toxicology programs through leading-edge technologies, quality assurance measurements, and laboratory management programs. GENETIC TOXICOLOGY Genetic toxicology studies are conducted early in the safety testing program of your pharmaceutical and biotechnology products. QPS conducts its genetic toxicology studies in a tiered approach, starting with an Ames test and progressing to the conduct of mammalian cell and in vivo assays, which are designed to assess the toxicological relevance of any earlier observations. HISTOPATHOLOGY Microscopic evaluation of tissues, coupled with clinical pathology data, remains a cornerstone of toxicological evaluation of your pharmaceutical and biotechnology products. Our group of experienced pathologists has an average of 12 years experience in the field. We have experience with any type of study from animal model evaluation, through preliminary non-GLP toxicity studies to formal GLP studies. DERMAL IRRITATION AND CONTACT SENSITIZATION Evaluation of skin irritation and contact sensitizing of your test material is done by QPS to determine the potential to provoke ocular irritation, dermal irritation, or sensitization.TRANSCRIPT
Toxicology and Preclinical ServicesWith over two decades of experience in delivering comprehensive toxicology services, QPS offers high quality low cost solutions to support your IND and NDA regulatory submissions
T O X I C O L O G Y O V E R V I E W
G E N E R A L T O X I C O L O G Y
R E P R O D U C T I V E T O X I C O L O G Y
C L I N I C A L P A T H O L O G Y
G E N E T I C T O X I C O L O G Y
H I S T O P A T H O L O G Y
D M P K
B I O C O M P A T I B I L I T Y T E S T I N G
C L I N I C A L D R U G D E V E L O P M E N T
B I O A N A L Y T I C A L
P H A R M A C E U T I C A L
P R E C L I N I C A L
B I O T E C H N O L O G Y
T R A N S L A T I O N A L M E D I C I N E
G L O B A L C R O
D I S C O V E R Y
Q U A L I T Y S E R V I C E S
Introduction of QPS’ Center of Toxicology and Preclinical Services in Taiwan:
At QPS-CTPS Taiwan, our commitment is to provide our valued
customers with a fast and reliable route to clinical phase I-II
studies. We offer you a wide range of toxicity and DMPK studies
as well as other preclinical safety tests that are essential for
your preclinical drug development programs. As our valued
client, you maximally benefit from our long track record of
designing large and specialized studies.
C L I N I C A L D R U G D E V E L O P M E N T
B I O A N A L Y T I C A L
P H A R M A C E U T I C A L
P R E C L I N I C A L
B I O T E C H N O L O G Y
T R A N S L A T I O N A L M E D I C I N E
G L O B A L C R O
D I S C O V E R Y
Q U A L I T Y S E R V I C E S
Quality and flexibility are key factors in our work. We work closely together with you and ensure that no regulatory studies are overlooked that are required for your IND filing. As a direct result, we will design and execute the most cost effective development strategies for your drug candidates.
QPS-CTPS is an ISO/IEC 17025 certified and GLP compliant (DOH, TAF OECD), AAALAC accredited facility and is part of the Taiwanese Medical Products Agency GLP inspection program. All studies are performed in compliance with OECD GLP guidelines and complete quality assurance is performed on studies used for regulatory purposes.
The animal facility is a barrier-designed facility, which houses various species including mice, rats, hamsters, guinea pigs, rabbits and dogs. Animal care and husbandry are conducted according to AAALAC guidelines. All studies are approved by a local Animal Ethics Committee.
Our vast experience gained from performing GLP studies and compiling
dossiers for US FDA submission for local and international
pharmaceutical and biotechnology companies within many different
disease therapies in the past decades clearly proves our ability to
effectively deliver high quality data to our customers.
Find out how to achieve your next development milestone ahead of time.
Call to schedule your tour at our toxicology and preclinical services facilities in Taipei, Taiwan.
D E V E L O P M E D I C I N E S
B I O A N A L Y T I C A L
P H A R M A C E U T I C A L
R E S P E C T
B E N E F I C I A L P A R T N E R S H I P S
D E D I C A T E D E M P L O Y E E S
S C I E N T I F I C E X P E R T I S E
V O L U N T E E R W O R K
B E N E F I T P A T I E N T S
Chromosome Aberration Assay- In CHO cells- In human lymphocytes
Micronucleus Assays- Micronucleus assay in CHO cells- Mouse micronucleus assay
Histopathology: Tissue and Slide Preparation Tissue Image Pathology Consultation and Evaluation
US Board Certified Histopathologist
DMPK: Protein Binding Blood and Urine Sampling Plasma Concentration Dosing Formulation Analysis Distribution and Excretion
Our services include the following:
General Toxicology: Single Dose Toxicity Studies Repeated Dose Toxicity Studies- Up to 180 days in rodents and up to
9 months in non-rodents- Routes of administration: oral,
intravenous (injection and infusion), intramuscular, subcutaneous, intraperitoneal and others
- Animal species: mice, rats, guinea pigs, hamsters, rabbits and dogs
Reproductive Toxicology: Fertility Teratology- Animal species: rat and rabbit
Clinical Pathology: Urine Analyses Hermatology Serum Chemistry
Genetic Toxicology: Gene Mutation Assays- Ames Test- In Vitro mouse lymphoma assay
Biocompatibility Testing: Acute Systemic Toxicity Test Pyrogen and LAL Test- Animal species: rabbit
Intracutaneous Irritation Test Skin Sensitization Test Cytotoxicity Test In Vitro hemolysis Mutagenicity Test Implantation Test
Miscellaneous: Irritation Studies- Eye irritation test- Dermal irritation test- Animal species: rabbit
Skin Sensitization Testing- Buehler test- Maximization test- Animal species: guinea pig
General Safety Testing
1
1 QPS|Taiwan
Call to arrange for a tour at QPS’ Toxicology Laboratory in Taiwan today
Time is of the essence
in drug development,
so contact a member
of the QPS Business
Development Team today
and find out what QPS
can do for you.
HQ BD Office Lily Rosa (USA)
+1 512 350 2827 [email protected]
Company Values: Integrity - We make and keep promises and build trust through honesty, proactive communication and reliability - Quality - We bring the highest level of technical expertise and judgement to our work - Customer Focus - We tap our global resources to provide service that is fast, flexible and integrated - Commitment - We work hard to solve problems and deliver results - People - We treat people with dignity, respect and fairness, and embrace our differences - Culture - We are friendly and fun. We provide opportunities to grow, we value loyalty and teamwork, and we recognize and reward performance.