Quiz 5 Flashcards
5 step process of FDA drug approval
- discovery/concept
- preclinical research
- clinical research
- FDA review
- FDA post-market safety monitoring
phases of human clinical studies
Phase 1: Small # people, without disease, exposed for toxicity or side effects
Dose finding
(can skip phase 1)
Phase 2: Tested on small patient population to evaluate therapeutic effect and dosage range
** “Open label”, no control group
Phase 3: Multi-center, RCTs
Drug safety is continually monitored, Compares outcome with drug versus no drug or another drug
Phase 4: Post-marketing surveillance
Drug safety is monitored throughout the life of the drug
Reports sent to FDA
Pharmacokinetics
the study of the time course of drug absorption, distribution, metabolism and excretion
(how does it move around)
Pharmacodynamics
the relationship between drug concentration at the active pharmacologic site and the response
Toxicology
study of toxins and how they affect the body in drug use
Pharmacogenetics
Study of how genetic facts affect drug use or results
generic name drug
(chemical name)
referring to the chemical makeup of a drug rather than to the advertised brand name under which the drug is sold
trade name drug
a standard term in the pharmaceutical industry for a brand name or trademark name
measuring performance skills
strength/rom/dexterity/sensation (MMT, dynamometer, goniometry, dexterity tests, sensation tests)
cognition/home environment/culture (MOCA, home safety checklist, cultural competency checklist)
balance/pain/perception (berg balance test, visual analog scale, McGill pain, test of visual perception)
measuring performance patterns
habits/routines/rituals/roles (interview, COPM, role and interest checklists)
coxa norma
angle of inclination = 125 degrees
coxa valga
increased angle (>125)
coxa vara
decreased angle (<125)
angle of torsion
one line parallel to the posterior femur condyles and a line through the head and neck of the femur. Normally ~15 degrees
anteversion of femur
Inward rotation of the femur
Excessive anteversion overloads the anterior hip including labrum and joint capsule
Causes: congenital or femur fracture
s/s: in-toeing, pain in hips and snapping at hip while walking
*cam impingement
retroversion of femur
Backward rotation of the femur
Excessive retroversion crushes the labrum
Causes: abnormal development of acetabulum (too deep), lesions in the head-neck juncture of hip ball, abnormal twist in the femur
s/s: external rotation when weight-bearing, poor balance, poor push off when running, can have out-toeing
*pincer impingement
lateral pelvic tilt - hip hike side
weak glut medius, tight quads and adductors
lateral pelvic tilt - hip drop side
tight glut medius, weak quads and weak/elongated adductors
would do hip alignment
function of medial and lateral meniscus of knee
Crescent shaped bands that are attached to the tibia
Absorbs shock and stabilizes the knee
Stabilizes against valgus and varus motions
normal angles of tibiofemoral alignment of knee
Long axis of femur and tibia intersect to create physiological valgus at the knee joint (185-190 degrees)
genu valgum
knock knees
compressive forces on lateral condyle
genu varum
bow legged
compressive forces on medial condyle
open pack position of knee
25 degrees flexion
Position of least amount of joint congruency
Capsule and ligaments are lax
Accessory motion/joint play is maximized
closed pack positions of knee
Knee extension
Position of most joint congruency
Capsule and ligaments maximally tight
Accessory motions minimized
