Biologic drug (recombinant drug) considerations A recombinant drug (a biologic) is produced through the application of biological processes involving DNA technologies. Biologic drugs are intended to be used to treat and manage diseases and health conditions in patients. Clinical trials would be used to obtain answers about the pharmacological product (Chow & Liu, 2013). However, they are carried out after approvals from relevant bodies in different countries. A clinical trial involves four stages, which must all be passed to prove that a biologic drug is safe to use and produces good biological effects (Chow & Liu, 2013). The clinical phases and considerations in each phase are summarized as follows: Phases     Considerations                                    * Safety                           Phase I      * Pharmacodynamics                              * Pharmacokinetics                              * Tolerability                                  * Efficacy                         Phase II     * Toxicity                                      * Dosing requirements                           * Patients and healthy individuals              * Size                                          * Duration                         Phase III    * Expenses                                      * Approval                                      * Consumer response                             * Pharmacovigilance                Phase IV     * Technical support                             * Drug interactions                             * Aggressive marketing              Figure 1. A table with a summary of the 4 phases of clinical trials. Phase I Phase I considerations for a biologic drug would include the following:   * Safety   * Pharmacodynamics   * Pharmacokinetics   * Tolerability Safety Drug safety is an important aspect that is assessed in clinical trials. The goal of assessing the safety of a drug is to ensure that it does not cause more adverse reactions than expected therapeutic benefits in the human body. The safety of the chosen recombinant drug would be determined in cases of pregnancy and overdose, among others (Chow & Liu, 2013). It will be important to determine the level of drug benefits in the scenarios because they may lead to adverse drug reactions. Although much information regarding the safety of the drug would be obtained from human subjects participating in the clinical trials, some information would be accessed from medical literature and pharmacovigilance agreements (PVAs). The safety consideration would encompass some aspects that would greatly determine the overall assessment in terms of safety. Adverse drug reactions are undesirable side effects that are caused by a drug. The drug benefit is defined as a therapeutic good that is associated with a drug. Efficacy is the level to which a pharmacological product produces good efficacy. Harm is the extent to which a drug causes tissue damage. Effectiveness of a drug is the extent to which a drug is metabolized. Drug metabolism determines how a drug produces good efficacy levels in the human body (Chow & Liu, 2013). The safety assessment in human subjects will mainly focus on comparing the benefits and limitations of the drug. It has been shown that drugs that produc