What is DS and DP?

What is DS and DP?

Biologic drug development consists of two fundamental components: the drug substance (DS) development, which can include the master and working cell bank development, manufacturing process development, and scale-up; and the drug product (DP) development, which includes the filling of the drug substance into the primary …

What is DS in thermodynamics?

There exists for every thermodynamic system in equilibrium an extensive scalar property called the entropy, S, such that in an infinitesimal reversible change of state of the system, dS = dQ/T, where T is the absolute temperature and dQ is the amount of heat received by the system.

What is DP manufacturing?

DP Manufacturing Inc. manufactures and distributes construction equipment. The Company offers products such as winches, hoists, gear drives, slewing ring bearings, and hydraulic pumps. DP Manufacturing markets its products to oilfield, government, utility, construction, and mining sectors globally.

What is dH DP at constant?

So, (dH over dP) is now – T (dV over dT) + V. For ideal gas, V equals to RT over P from the equation of state. Then, (dH over dP) at constant T becomes zero. Thus, enthalpy does not depend on pressure at constant T and it is a function of temperature only.

Is API the same as drug substance?

“An active pharmaceutical ingredient (API) is a substance which is used in the preparation of a drug product. API and excipients (inert materials) together form a drug product which is used for the treatment of diseases in human beings. The API is also called as a drug substance.”

What is bulk drug substance?

Bulk drug substance means any substance that is represented for use in a drug and that, when used in the manufacturing, processing, or packaging of a drug, becomes an active ingredient or a finished dosage form of the drug, but the term does not include intermediates used in the synthesis of such substances.

What is DS DV?

dv/ds is a differential form of velocity by displacement. Though this is not directly used for any purpose whatsoever, if you mutliply this with v, it forms v.dv/ds. v.dv/ds = a ; where a = acceleration and v = velocity. Explanation: v=dv/dt.

What is DH in thermodynamics?

The enthalpy per unit mass is the specific enthalpy, h = u + pv. It is a function of the state of the system. In a general thermodynamic process: dh = du + pdv + vdp = dq + vdp, where dq is the path dependent heat transfer to the system.

Is API a drug substance?