Pharmaceutical Development As a Means For Ensuring Financial Success

Developing a new pharmaceutical active ingredient isn't just about developing a molecule with the best biological activity. The physical form has to be optimised to ensure the top possible performance and that no one can find a superior form and usurp your hard won patent position.

Pharmaceutical development is the progression of a new chemical entity found in early screening through to the later stages of clinical development. Pharmaceutical development includes the construction of a scaleable manufacturing process as well as refinement of the optimum physical form of the Active Pharmaceutical Ingredient (API).

Pharmaceutical development starts with an active compound that displays the desired response in an assay. However, in vivo (in the organism), the compound might not get to the point of action as it so easily did in vitro (lit. in glass). Pharmaceutical development is needed to turn the compound into a form that is stable, is biologically available and can be made into the most favourable formulation. A balance is needed between the water solubility and lipophilicity (ability to dissolve in fats) characteristics of the drug. Skilled scientists will be able to turn a compound with poor physical properties into one that can be crystallised and processed effectively. A Salt screen will lead to candidate compounds that can subsequently be selected and further optimised. A balance will need to be made between optimal drug performance and manufacturability.

It is essential to integrate manufacturing expertise with solid-state expertise using a diverse range of state-of-the-art equipment and facilities operating to current Good Manufacturing standards. Scale up and production of kilo quantities of the drug under GMP conditions completes the early pharmaceutical development phase. If properly conducted, the optimal physical form will be taken forward coupled with the means to manufacture. Ultimately your intellectual property will be secured and long term financial success guaranteed.

Static Dosing and Rhythmic Cycling

If your physician feels you are an ideal candidate for static dosing of bioidentical hormones, he or she will initially prescribe a low dosage of the hormones to test your body's response. Following several months of taking bioidenticals at a low dosage, doctors will then reorder blood samples, which will be scrutinized for your detailed hormonal levels. If your symptoms are somewhat alleviated and the levels remain relatively optimal, doctors will the set forth a regimen of taking bioidenticals on a daily basis, with an increase in dosage on the eighteenth and twenty-eighth day. The increase in dosage on these two days will mimic the natural physiology of a young woman's body, induce a period, and give a woman the full complement of hormonal attributes they enjoyed before the aging process.

The second method of taking in bio identical hormones for women involves charting and taking the hormones on a rhythmic cycle in concurrence with the lunar phases and tides. This process, although seemingly a little too out there for some women, really makes sense and attempts to mimic the reproductive and hormone cycles of women prior to the advent of modern society, and all the associated stress, irregular sleeping patterns, and in turn, irregular hormonal production levels. One of the more well-known processes of administering bioidenticals rhythmically is known as the Wiley Protocol, which advocates large dosing of hormones, natural and safe bioidentical hormones, to women in tailored ratios for their unique bodies. Many women have found a large amount of relief and overall happiness in the health and their lives while using rhythmic cycling and the Wiley Protocol

Every woman wants to take care of their body, for as long as possible. In many women cases today, the option to utilize hormonal replacement therapy is a wise and healthy decision, if made with the intention of using bioidentical hormones. The numerous side-affects, such as breast and ovarian cancer, associated with synthetic hormones, not to mention the lack of benefits in light of bioidentical hormone replacement therapy's offerings should truly be the deciding factor for any woman serious about living a long, healthy, happy lifestyle.

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