Drug development Flashcards
A newly discovered VEGF inhibitor for cancer has just finished FDA approval November 2010 and was released to doctors and patients early 2011. Dr. Bueno, a medical oncologist, wanted to show the efficacy of the new drug to her patients with metastatic ovarian cancer Roche, a pharmaceutical company gave her a grant to gather all adverse events of the said drug
A. Phase 1
B. Phase 2
C. Phase 3
D. Phase 4
D
Phase 4 of Clinical trials is post-marketing surveillance where adverse events are monitored after the drug is released to the market
Scientists want to discover the effects of the Zea mays plant on insulin resistance. A clinical trial conducted using rat models monitored the concentration of the plant in the kidneys using clot analysis and real time PCR. They also measured the blood sugar, serum insulin, and HBA1C
A. Phase 1
B. Phase 2
C. Pre-clinical
D. Phase 4
C
Pre-Clinical testing pertains to laboratory and animal testing done to determine drug safety and efficacy
A new drug just got FDA approval. The test design included administration of 25 mg to 25 healthy patients. Results show T1/2 of ___ and Cmax of ____.
A. Phase 1
B. Phase 2
C. Phase 3
D. Phase 4
A
Phase 1 is testing the drug to 20-100 healthy volunteers, geared towards determining the safe dosing range and pharmacokinetic properties of the drug.
______-inferiority, open-labeled, randomized control trial involving ultra-long acting basal insulin was recently published in the Lancet. The study was conducted in 69 sites worldwide, involving Type 1 DM patients, and compared degludec with the long acting insulin Lantus. Results showed that there was a fall of 0.4% in the HbA1c using degludec. The manufacturer has already submitted the dossier to the FDA but has not been approved for marketing.
A. Phase 4
B. Phase 2
C. Phase 3a
C
Phase 3a consists of randomized multi-center drug trials done before new drug application to determine drug efficacy
The efficacy and safety of the ophthalmic solution Diquafasol was conducted in patients with Dry Eye Syndrome. The pilot study is a randomized, double-blind, multicenter, parallel-group, placebo controlled trial involving 286 Japanese patients who were randomized to either the drug group or placebo group. Results showed that 1% and 3% diquafasol is effective and safe.
A. Phase 1
B. Phase 2a
C. Phase 2b
D. Phase 2c or 3 (?)
B
Phase 2a studies evaluate the drug’s safety and efficacy in selected populations of patients with the disease to be treated, diagnosed or prevented. Objectives may focus on dose-response, type of patient, frequency of dosing or other safety and efficacy characteristics.
Phase 2b studies evaluate the drug’s safety and efficacy in patients with the disease to be treated, diagnosed or prevented. These studies represent the most rigrous demonstration of the drug’s efficacy, refered to as pivotal trials
Dr. Ramos and his group of scientists wanted to study the newly discovered molecule GA101 on cancer patients. They used rat models showing the pharmacodynamics and pharmacokinetics of the molecule and were able to prove that it was able to decrease the size of the mass.
A. Pre-clinical
B. Phase 1
C. Phase 2
D. Phase 3
A
Comparative study on effects of carvedilol vs metoprolol, randomized, 100 participants with DM2
A. Phase 1
B. Phase 2
C. Phase 3
D. Phase 4
B
Phase 2 trials evaluate the drug’s effectiveness in 1100-500 patients with the disease.
Bevacuzimab (Avastin) is a newly discovered chemotherapeutic drug released and marketed since
2011. Dr. Bernardo wanted to determine the effects of the drug to his ovarian cancer patients. Roche, a pharmaceutical company, gave him a grant to determine the adverse effects of the drug.
A. Phase I
B. Phase II
C. Phase III
D. Phase IV
D
A group of scientists want to discover the effects of the makahiya plant on insulin resistance. A clinical trial was conducted using rat models, and monitored the concentration of the plant in the kidneys using western blot analysis. Also measured blood sugar, serum insulin, and HBA1C levels
A. Phase I
B. Phase II
C. Pre-clinical
D. Phase IV
C
RCT, open-labelled, humans, 600+ DM Type 2, 69 worldwide sites
A. Phase I B. Phase II C. Phase III D. Phase IV
C
Efficacy of drug with Dry Eye Syndrome. Trial involving 200 patients
A. Phase I
B. Phase II
C. Phase III D. Phase IV
B
True of the legal requirements for herbal medicines:
a. allowed to have active ingredients, excipients, and isolates from the same plant
b. Plant authentication for the source of the herbal medicine from FDA-recognized taxonomist
c. should abide by the limits set on heavy metals, aflatoxin, pesticide residue, etc.
d. should submit pre-clinical toxicity studies (both short and long term)
A
Executive Order No. 175 – May 22, 1987: Act to ensure “purity, safety, efficacy and quality of drugs and devices”.
Product registration requires submission to BFAD of all required data including animal and/or clinical tissues.
BFAD should supervise
Administrative Order No. 172 S 2004 – 16 Sept. 2004
“Guidelines on the Registration of Herbal Medicines”
Section 13. Evidence of safety and efficacy.
Herbal Medicine: finished labeled products that contain as active ingredients aerial or underground part/s of plants or other materials or combination thereof, whether in the crude state or as plant preparation, plant material includes prices, juices, gums, fatty oils, essential oils and other substances of this nature.
Herbal medicine however, may contain excipients in addition to the active ingredients. Medicines containing plant material/s combined with chemically defined isolated constituents of plants, are not considered to be herbal medicine/s.
The RA No. 9502, the Universally Accessible Cheaper and Quality Medicines Act of 2008 defines drugs and medicines
A. as any chemical compound and biological substances other than food, intended for use in the treatment, prevention or diagnosis of disease in humans or animals
B. as any article other than food intended to affect the structure or any function of the human body or animals
C. to include herbal and/or traditional drugs which are the articles of plants or animals origin used in folk medicine which are recognized in the Philippines National Drug Formulary
D. All of the above
D
Pre-Clinical Testing of drugs and herbal products using animal
A. An Institutional Animal Research Committee should be established to ensure compliance with the ethical and technical requirements.
B. Investigators and other personnel shall be appropriately qualified and experienced for conducting procedures on living animals. The personnel should be given protection from zoonotic diseases and inappropriate exposure to hazardous chemicals and substances.
C. For surgical or other painful procedures, it is no longer needed to give anesthesia on animals paralyzed by clinical agents.
D. a and b only
D
The guidance on the Non-clinical safety studies for the conduct of human clinical trials required by the 2009 ICH of technical requirements for registration of pharmaceuticals for human use include:
A. As its specific objective, to reduce the use of animals in accordance with 3R (reduce, replace, re) principles
B. To use new in vitro alternative methods for safety evaluation
C. As its scope assessment of carcinogenicity potential for drugs that have special cause for concern
D. A and B
D
