New drug substances

International Conference on Harmonisation Draft Guidance on Specifications Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products Chemical Substances Notice, Fed Regist. Docket No. 97D-0448, 1997. 

HHS/FDA International Conference on Harmonisation Stability Testing of New Drug Substances and Products Guideline Availability Notice, Federal Register, September 22, 1994... 

HHS/FDA International Conference on Harmonisation, Guidelines Availability Impurities in New Drug Substances Notice, Federal Register, January 4, 1996 An FDA Perspective on Bulk Pharmaceutical Chemicals, Edmund M. Fry, Pharmaceutical Technology, February 1984, Pages 48-53... 

Fig. 13-2. Establishing procedures for chiral new drug substances and new medicinal products containing new chiral drug substances.

GL3 Stability 1 Stability testing of new drug substances and products... 

A guideline for evaluation of the photostability of new drug substances and dosage forms was published in 1997 [39]. Subsequently, a joint study was undertaken by the U.S. Food and Drug Administration (FDA) and Pharmaceutical Research and Manufacturers of America to evaluate the ICF1 guideline. A draft chapter for the United States Pharmacopeia, based on the guideline and the joint study, has been published in Pharmacopeial Forum [40]. 

The goals of the program are, therefore, (1) to establish the necessary physicochemical parameters of a new drug substance, (2) to determine its kinetic rate profile,... 

It is advantageous with a new drug substance to be able to estimate what its solubility will be prior to carrying out dissolution experiments. There are several systems of solubility prediction, most notably those published by Amidon and Yalkowsky [14-16] in the 1970s. Their equation for solubility of p-aminobenzo-ates in polar and mixed solvents is a simplified two-dimensional analog of the Scatchard-Hildebrand equation and is based on the product of the interfacial tension and the molecular surface area of the hydrocarbon portion of a molecule. 

It is important for the formulator of a new drug substance to know with which excipients he can work and with which he cannot. Some pharmaceutical incompatibilities are known to the formulator, e.g., magnesium stearate/aspirin, and glucose/amines [53],... 

The preparation of a new drug substance or dosage form for evaluation in clinical trials must meet the same regulatory requirements and controls as a marketed product. The cGMP requirements for clinical trial products are outlined by FDA and are discussed in Chapter 20. 

This revision not only concerned itself with new drug substances, but was extended to cosmetics and devices. 

Because of today s myriad regulations, the NDA submission has become a compilation of information that could be compared in size with any one of the well-known encyclopedias. Before 1962, only a few volumes were necessary for an NDA submission [11]. Today it is not uncommon for this justification to consist of as many as 200 volumes of information (see Table 2). It is important for the pharmacy and medical practitioner to have some sensitivity to the many requirements and high cost placed on manufacturers who develop and market new drugs (especially new drug substances) today. 

Description of the source and preparation of any new drug substance used as a component... 

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