Glossary

Rapid Aseptic Fluid Transfer

Redundant Array of Independent Disks

Random Access Memory

Assignment of subjects to different treatments, interventions, or conditions according to chance rather than systematically (e.g., as dictated by the standard or usual response to their condition, history, or prognosis, or according to demographic characteristics). Random assignment of subjects to conditions is an essential element of experimental research because it makes more likely the probability that differences observed between subject groups are the result of the experimental intervention.

Chips which can be called read/write memory, since the data stored in them may be read or new data may be written into any memory address on these chips. The term random access means that each memory location (usually 8 bits or 1 byte) may be directly accessed (read from or written to) at random. This contrasts to devices like magnetic tape where each section of the tape must be searched sequentially by the read/write head from its current location until it finds the desired location. ROM memory is also random access memory, but they are read only not read/write memories. Another difference between RAM and ROM is that RAM is volatile, i.e. it must have a constant supply of power or the stored data will be lost.

(RAPD; pronounced 'rapid') A technique using single, short (usually 10-mer) synthetic oligonucleotide primers for PCR. The primer, whose sequence has been chosen at random, initiates replication at its complementary sites on the DNA, producing fragments up to about 2 kb long, which can be separated by electrophoresis and stained with ethidium bromide. A primer can exhibit polymorphism between individuals, and polymorphic fragments can be used as markers.

A protocol for labelling DNA in vitro. A sample of random oligonucleotides (6 or 14 nucleotides long) containing all possible combinations of nucleotide sequences is hybridized to a DNA probe. Then, in the presence of a DNA polymerase and the four deoxyribonucleotides – one of which is labeled – the 3’ hydroxy ends of the hybridized oligonucleotides provide initiation sites for DNA synthesis that uses the separated strands of the probe DNA as a template. This reaction produces labeled copies of portions of the probe DNA.

(ICH Q2 (R1))The range of an analytical procedure is the interval between the upper and lower concentration (amounts) of analyte in the sample (including these concentrations) for which it has been demonstrated that the analytical procedure has a suitable level of precision, accuracy and linearity.

(ISO) A limit check in which both high and low values are stipulated.

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A structured software requirements discovery technique which emphasizes generating prototypes early in the development process to permit early feedback and analysis in support of the development process.

(ICH Q6A) An immediate release solid oral drug product is considered rapidly dissolving when not less than 80% of the label amount of the drug substance dissolves within 15 minutes in each of the following media: (1) pH 1.2, (2) pH 4.0, and (3) pH 6.8.

Regulatory Affairs Professionals Society

Rare diseases, as define by the Orphan Drug Act, are those diseases or conditions affecting less than two hundred thousand persons in the United States at the time of designation. Or they may be diseases or conditions that affect more than two hundred thousand persons but for which the costs of developing a drug cannot be recouped within seven years from sales in the United States.

Using the known three-dimensional structure of a molecule, usually a protein, to design a drug molecule that will bind to it. Usually viewed as an alternative to drug discovery through screening many molecules for biological activity.

Resource Analysis Task Team (ISPE term)

Any worksheets, records, memoranda, notes, or exact copies thereof that are the result of original observations, measurements, recordings, etc. of an activity, such as a study, operation, investigation, etc., and are necessary for the reconstruction and evaluation of the report of that activity.In the event that exact transcripts of raw data have been prepared (e.g., tapes which have been transcribed verbatim, dated, and verified accurate by signature), the exact copy or exact transcript may be substituted for the original source as raw data. Raw data may include photographs, microfilm or microfiche copies, computer printouts, magnetic media, dictated observations, and recorded data from automated instruments. As such, the raw data may exist in either hard/paper copy or electronic format.

(ICH Q7) A general term used to denote starting materials, reagents, and solvents intended for use in the production of intermediates or APIs.

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