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Bone safety
Bone Structure

A. Align to Biomechanical Loading

Anatomical structure of bones depends mainly on the genetic and biomechanical influences to their length, width, shape and contour, and strength. In general, mechanical rules, structure alignment streams along the loading axis.

B.Cortex and Trabecular

Bone has cortical shell as the predominant weight bearing component and trabeculae as the sponge cushion within the marrow.

C.Blood Supply

Bone marrow is the source for hematopoiesis, therefore has conspicuous blood supply networks.


Bone Resorption VS. Bone Formation

At PharmaLegacy, our scientists have cumulated more than 30 years of experiences in bone physiopathology, especially in bone safety, metabolic bone diseases, osteoarthritis and osteoporosis. Our familiarity with IND/NDA and SOP driven GLP quality assurance operations can aid your regulatory submission.Maintenance on bone integrity is crucial to hematopoiesis, locomotion, and muscles/tendons insertion; and is pivotal to calcium homeostasis, hormonal metabolism and weight bearing daily activities. The gain on bone mass is through modeling where bone formation is greater than that of bone resorption. The bone loss during aging is through greater bone resoption to that of bone formation in remodeling.

Drug Effects

Maintenance of bone mass is through the balance between amount of bone resorbed and formed by cumulative sum from the outputs of BMUs. Drugs that distributed through blood flow can easily affect the balance of bone resorption and formation. The known chemicals, such as fluoride, aluminum, lead, etc. and inflammation/immune modulator medicine, such as cyclosporine, steroids, conjugated antibody, etc. can have detrimental effects on bone physiology and lead to bone pathology with increased risk of fracture as the end results. It is, therefore, prudent to examine the influence of medicinal products either small molecules or protein-based agents on bone for safety purpose.


Bone Safety Studies
We are able to perform bone safety studies in the following situations:

·     compound that is known to modify the bone remodeling process;

·     compound that may have an effect on calcium homeostasis, PTH/CT/1,25VitD axis Compound that alters the differentiation of marrow cells;

·     compound that is composed of heavy metals Compound that may affect gonadal hormone status;

·     compound that will be given to pediatric or renal patients;

·     compound that may have an effect at the pituitary/hypothalamus axi.

Tools used by the bone biologist:

·     Bone markers (Turnover, Formation and Resorption Markers)

·     Bone Mass/ Mineral Density Determinations (X-ray, DXA, pQCT, CT scan  and Micro-CT) Bone Strength Determinations (Biomechanical Testing)

·     Bone Histomorphometry

·     Histopathology


Histomorphometry Parameters

Static parameters:

·     Bone Area & Perimeter

Dynamic Parameters:

·     Bone Formation Rate

Cellular Parameters:

·     Osteoblasts & Osteoclasts

Unusual Tissues:

·     Fibrosis, Woven Bone, Excessive Osteoid, Diffused Bone Formation, Defect and Repair Area, Implant/ Bone Surface

Exotic Parameters:

·     Wall Width, Activation Frequency, Mineralization Lag Time

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