Biologics R&D
Preparation that are used to stimulate the body's immune response against diseases. Required specialized assay and testing to assure their quality and safety on a lot-to-lot basis.
What is a vaccine?
Constant _______ assures the reproducibility of safety and efficacy
What is quality?
One of the core ethical principles that refers to the duty to protect research subjects from harm
What is beneficence?
Refers to creation of the mind such as inventions, literary and artistic works , designs, symbols, names, an images used in commerce.
What is intellectual Property.
Established in 1990 by the regulatory agencies and industry associations of Europe, Japan , and the US to achieve harmonisation in the interpretation and application of technical guidelines and requirements for pharmaceutical product development and registration.
What is the ICH?
Pre-clinical testing is a prerequisite to moving a candidate vaccine from the laboratory to the clinic. It involves _________ before testing in humans.
What is testing in animals?
A single pure active constituent is isolated, purified, and standardized. Herbal formulations are _______ of active principles.
What is a multicomponent?
An integral component of respect for persons which means the right to self determination?
What is autonomy?
Number of years of protection given to patents is _____ while ____number of years is given to utility models
What is 20 and 7 respectively?
GMP is for Manufacturing Quality Control, _____ is for non-clinical studies with animals.
What is GLP?
Immunogenicity studies involve use animals such as mice, rabbits, or monkey. A primary concern in immunogenicity studies is __________.
What is how close the animal model assemble the disease and immune response in humans?
Developing a herbal drug involves collection and authentication of the material, pharmacognostic, phytochemical, and pharmacologic evaluation, b_____, and s________.
What is bioassay and standardization?
Research studies in the university are registered to the ______________
What is Research Ethics Board?
IPs are a type of ________ property
What is intangible?
Defined as the percentage reduction in the incidence rate of specific disease in vaccinated individuals as compared to that in unvcccinated individuals. Measure of direct protection.
What is vaccine efficacy?
Is a scientific procedure to determine the nature, biological effects or potency of the substance through the use of intact animal or plant(in vivo) or use of isolated organ, tissue, or cell (in vitro)
What is bioassay?
International ethical and scientific quality standard for designing, conducting, monitoring, auditing, recording, analyzing, and reporting clinical research.
The foundation of clinical trials that involve human subjects.
What is Good Clinical Practice?
Is the government agency mandated to administer and implement State policies on intellectual property (IP) to strengthen the protection of IP rights in the country.
What is IPOPHL?
ICH's mission is to achieve greater harmonisation worldwide to ensure that ____, _____, and _____are developed, and registered and maintained in the most resource efficient manner whilst meeting high standards.
What is safe, effective, and high quality?
The protection rate conferred by vaccination in a specified population?
What is vaccine effectiveness?
Standardization of botanicals refers to the production of plant preparation that is consistent in terms of c_____ and e_____
What is composition and efficacy?
The _______ ensures the safety of volunteers in clinical research while the _________checks research misbehavior in the university.
What is Research Ethics Board and Office of Research Integrity?
To be patentable, an invention in the Philippines must be new, involves an inventive step, and ________.
What is industrially applicable?
Retrospective inspection or audit is not effective to protect integrity of data. Preventive and pro____ approach i employed in GxPs
What is proactive?